Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03176134 | A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018) | PHASE3 | COMPLETED | 100 | — | — | Jan 20, 2019 | Jul 6, 2023 | Jul 31, 2025 | 58 | United States, Brazil +12 |
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.
| 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. |
| 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 |
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...