Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tedizolid
TR-701 FA single infusion · 7 trials · 7 indications
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. The number of participants who discontinued study treatment due to an AE were reported.
Hematopoietic cytopenia is a condition where there is a lower-than-normal amount of one or multiple kinds of blood cells. A standardized Medical Dictionary for Regulatory Activities (MedDRA) query for hematopoietic cytopenia was conducted. The number of participants with a hematopoietic cytopenia were reported.
Early clinical response is defined as responder if there is \>=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.
The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.
AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of pharmacokinetic (PK) outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate AUC0-last for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate AUC0-inf for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate Cmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate Tmax for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK outcomes in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, tedizolid phosphate t½ for multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol.
AUC0-last of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate AUC0-last for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.
AUC0-inf of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate AUC0-inf for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this endpoint and were excluded from this protocol-specified analysis.
Cmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate Cmax for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.
Tmax of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate Tmax for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.
t½ of tedizolid phosphate was quantified in participants receiving tedizolid phosphate. As specified in the protocol, tedizolid phosphate t½ for single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1) were not included in this outcome and have been reported separately in the record. Tedizolid phosphate PK analysis was not planned or conducted in Part B (Groups 4, 5, 6), per protocol. Participants in Group 2 Cohort 2 study arm did not meet the criteria for PK per protocol analysis population for this outcome and were excluded from this protocol-specified analysis.
AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-last for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, AUC0-inf for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Cmax for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, Tmax for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. Protocol specified analysis of PK endpoints in Group 1 was done irrespective of age (28 days to \<24 months, across ages in Cohorts 1 and 2). As specified in the protocol, t½ for tedizolid metabolite in multiple dose (Part A Group 2 Cohort 2, Group 3 Cohort 2) and Part B (Groups 4, 5, 6) were not included in this endpoint and have been reported separately in the record.
AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. This was analyzed in the per protocol population consisting of the subset of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit treatment effects, based on the underlying scientific model and had data available for this endpoint. As specified in the protocol, AUC0-last for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.
Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, Cmax for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.
Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, Tmax for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.
AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach to be used in this noncompartmental analysis would allow data collected to generate single concentration listing. However, protocol-specified PK sampling did not characterize the terminal elimination phase; therefore, AUC0-inf of tedizolid metabolite could not be estimated for multiple dose study arms (Part A Group 2 Cohort 2 and Part A Group 3 Cohort 2). As specified in the protocol, AUC0-inf for tedizolid metabolite in single dose (Part A Group 1\[Cohorts 1 and 2\],Group 2 Cohort 1, Group 3 Cohort 1; Part B\[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.
t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach to be used in this noncompartmental analysis would allow data collected to generate single listing. However, protocol-specified PK sampling did not characterize the terminal elimination phase; therefore, t½ could not be estimated for multiple dose study arms (Part A Group 2 Cohort 2 and Part A Group 3 Cohort 2). As specified in the protocol, t½ for tedizolid metabolite in single dose (Part A Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 3 Cohort 1; Part B \[Groups 4, 5, 6\]) were not included in this endpoint and have been reported separately in the record.
AUC0-last of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, AUC0-last for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
AUC0-inf of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, AUC0-inf for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
Cmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single concentration listing. As specified in the protocol, Cmax for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
Tmax of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, Tmax for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
t½ of tedizolid (metabolite) was quantified in participants receiving tedizolid phosphate. The per protocol statistical approach used in this noncompartmental analysis allowed data collected to generate single listing. As specified in the protocol, t½ for tedizolid metabolite in Part A (Group 1 \[Cohorts 1 and 2\], Group 2 Cohort 1, Group 2 Cohort 2, Group 3 Cohort 1, Group 3 Cohort 2) were not included in this endpoint and have been reported separately in the record.
Cmax of tedizolid phosphate in participants ages 6 to \<12 years (Group 1) and 2 to \<6 years (Group 2). Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Time to reach peak plasma concentration (Tmax) of tedizolid phosphate in participants ages 6 to \<12 years (Group 1) and 2 to \<6 years (Group 2). Tedizolid phosphate concentrations were below the lower limit of quantification in Group 3 and Group 4. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Terminal elimination half-life (T1/2) of tedizolid phosphate following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
CL of IV tedizolid phosphate in participants ages 6 to \<12 years (Group 1) and 2 to \<6 years (Group 2).
CL/F of oral suspension tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to \<12 years (Group 3) and 2 to \<6 years (Groups 4).
Maximum observed drug concentration in plasma (Cmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Time to reach peak plasma concentration (Tmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Terminal elimination half-life (T1/2) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to \<12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to \<12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to \<6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
CL of IV tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to \<12 years (Group 1) and 2 to \<6 years (Group 2).
CL/F of tedizolid, in participants ages 6 to \<12 years (Group 3) and 2 to \<6 years (Groups 4).
The area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose, normalized to dosage, was calculated. Per protocol, this outcome used pooled groups as follows: The IV Group pooled Groups 1 and 2, who received tedizolid phosphate via intravenous (IV) administration; the Oral Group pooled groups 3 and 4, who received tedizolid phosphate via oral administration. Pharmacokinetic sampling occurred at the following time points: Group 1 (part of the IV Group): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (part of the IV Group): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (part of the Oral Group): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (part of the Oral Group): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.
Cmax, Area Under Curve, Tmax t1/2 will be compared between each renal group and the control group, including calculation of geometric mean ratio and corresponding 90% confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Tedizolid phosphate 6 to <12 Years | EXPERIMENTAL | Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to \<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \<30 kg), by IV and/or oral suspension for 6 to 10 days. |
| Cohort 1: Comparator 6 to <12 Years | ACTIVE_COMPARATOR | Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days. |
| Cohort 2: Tedizolid phosphate 2 to <6 Years | EXPERIMENTAL | Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to \<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \<30 kg), by IV and/or oral suspension for 6 to 10 days. |
| Cohort 2: Comparator 2 to <6 Years | ACTIVE_COMPARATOR | Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days. |
| Cohort 3: Tedizolid phosphate 28 Days to <2 Years | EXPERIMENTAL | Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to \<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \<30 kg), by IV and/or oral suspension for 6 to 10 days. |
| Cohort 3: Comparator 28 Days to <2 Years | ACTIVE_COMPARATOR | Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days. |
| Cohort 4: Tedizolid phosphate Birth to <28 Days Term and Preterm Neonates | EXPERIMENTAL | Participants will receive tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose is to be determined based on results of another study (NCT03217565) covering the age range. |
| Cohort 4: Comparator Birth to <28 Days Term and Preterm Neonates | ACTIVE_COMPARATOR | Participants will receive comparator IV and/or oral per local standard of care for 10 to14 days. |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | EXPERIMENTAL | Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo. |
| Linezolid | ACTIVE_COMPARATOR | Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days. |
| Tedizolid phosphate IV | EXPERIMENTAL | Ventilated HABP/VABP participants receive tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia. |
| Linezolid IV | ACTIVE_COMPARATOR | Ventilated HABP/VABP participants receive linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia. |
| Part A Group 1 Cohort 1: Single Dose IV Tedizolid Phosphate 28 days to <6 months | EXPERIMENTAL | Pediatric participants 28 days to \<6 months of age will receive a single dose (SD) intravenous (IV) infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg. |
| Part A Group 1 Cohort 2: Single Dose IV Tedizolid Phosphate 6 months to <24 months | EXPERIMENTAL | Pediatric participants 6 months to \<24 months of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg. |
| Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (full term) birth to <28 days | EXPERIMENTAL | Full term (FT) neonates from birth to \<28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg. |
| Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (full term) birth to <28 days | EXPERIMENTAL | FT neonates from birth to \<28 days of age will receive multiple dose (MD) IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg, administered twice daily for 3 days. |
| Part A Group 3 Cohort 1: Single Dose IV Tedizolid Phosphate (preterm) birth to <28 days | EXPERIMENTAL | Preterm (PT) neonates from birth to \<28 days of age will receive an SD IV infusion of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg. |
| Part A Group 3 Cohort 2: Multiple Dose IV Tedizolid Phosphate IV (preterm) birth to <28 days | EXPERIMENTAL | PT neonates from birth to \<28 days of age will receive MD IV infusions of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg, administered twice daily for 3 days. |
| Part B Group 4: Single Dose Oral Tedizolid Phosphate 28 days to <24 months | EXPERIMENTAL | Pediatric participants 28 days to \<24 months of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg. |
| Part B Group 5: Single Dose Oral Tedizolid Phosphate (full term) birth to <28 days | EXPERIMENTAL | FT neonates from birth to \<28 days of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg. |
| Part B Group 6: Single Dose Oral Tedizolid Phosphate (preterm) birth to <28 days | EXPERIMENTAL | PT neonates from birth to \<28 days of age will receive an SD oral suspension of tedizolid phosphate according to body weight: 3 mg/kg for body weight \<10 kg or 2.5 mg/kg for body weight 10 to \<30 kg. |
| Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 years) | EXPERIMENTAL | Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 5 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 years) | EXPERIMENTAL | Participants 6 to \<12 years of age received a single intravenous infusion of tedizolid phosphate dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| Group 2 Cohort 1: Tedizolid IV 6 mg/kg (2 to <6 years) | EXPERIMENTAL | Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 6 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| Group 2 Cohort 2: Tedizolid IV 3 mg/kg (2 to <6 years) | EXPERIMENTAL | Participants 2 to \<6 years of age received a single intravenous infusion of tedizolid phosphate dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| Group 3: Tedizolid oral 4 mg/kg (6 to <12 years) | EXPERIMENTAL | Participants 6 to \<12 years of age received a single dose of tedizolid phosphate oral suspension dosed at 4 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| Group 4: Tedizolid oral 3 mg/kg (2 to <6 years) | EXPERIMENTAL | Participants 2 to \<6 years of age received a single dose of tedizolid phosphate oral suspension dosed at 3 mg/kg of total body weight. Maximum dose is 200 mg of tedizolid phosphate. |
| Experimental Arm | EXPERIMENTAL | Day 1: participants will receive midazolam (2 mg); Day 3: participants will receive rosuvastatin (10 mg); Days 5-13: participants will receive tedizolid phosphate (200 mg); Day 14: participants will receive tedizolid phosphate (200 mg) plus midazolam (2 mg); Day 15: participants will receive tedizolid phosphate (200 mg); Day 16: participants will receive tedizolid phosphate (200 mg) plus rosuvastatin (10 mg); Day 17: participants will receive tedizolid phosphate (200 mg) |
| Renal Impairment Nondialyzed | EXPERIMENTAL | - |
| Renal Impairment Dialyzed | EXPERIMENTAL | - |
| Matched Control | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tedizolid phosphate | DRUG | Tedizolid phosphate IV solution or oral suspension |
| Comparator | DRUG | Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the trial site and administered per local standard of care |
| Tedizolid (BAY119-2631) | DRUG | 50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days |
| Placebo Tedizolid (BAY119-2631) | DRUG | 50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days |
| Linezolid | DRUG | 50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days |
| Placebo Linezolid | DRUG | 50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days |
| IV Tedizolid Phosphate | DRUG | A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV. |
| Oral Suspension Tedizolid Phosphate | DRUG | A single dose of tedizolid phosphate administered as an oral suspension. |
| Tedizolid Phosphate (IV) | DRUG | 200 mg/vial powder for injection |
| Tedizolid Phosphate (oral suspension) | DRUG | Powder for oral suspension 20 mg/mL following reconstitution |
| midazolam | DRUG | 2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14 |
| rosuvastatin | DRUG | 10 mg tablet administered as a single oral dose on Days 3 and 16 |
| TR-701 FA single infusion | DRUG | Single IV infusion, 200 mg daily for 7 days |
| TR-701 FA | DRUG | Two separate infusions of 200 mg |
Inclusion Criteria: * Has a parent/legally acceptable representative who is able to give documented informed consent * Has acute bacterial skin and skin structure infections (ABSSSI), defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection * Local...
TR-701 FA single infusion is an investigational small molecule being studied for use in patients with renal impairment. It is in Phase 1 clinical development for this condition, with a completed pharmacokinetics and safety study evaluating its effects in this patient population.
TR-701 FA single infusion is being developed by Merck & Company, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for renal impairment.
TR-701 FA single infusion is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for use in patients with renal impairment. One Phase 1 clinical trial has been completed for this indication.
TR-701 FA single infusion has one completed clinical trial, NCT01452828, titled "A Pharmacokinetics and Safety Study in Subjects With Renal Impairment." This Phase 1 study enrolled 24 participants in the United States and evaluated the drug's pharmacokinetics and safety in patients with renal impairment.
TR-701 FA single infusion is a formulation of TR-701, specifically designed for single intravenous infusion. The drug is being developed by Merck & Company, Inc. for renal impairment and is currently in Phase 1 clinical development.