Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ceftolozane/Tazobactam · 5 trials · 8 indications
Clinical response was classified as "cure" or "failure". Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. The percentage of participants with clinical response of clinical cure or clinical failure at TOC was summarized.
To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in stratified adult participants with ventilated nosocomial pneumonia (VNP) (participants with either ventilator-associated bacterial pneumonia \[VABP\] or ventilated hospital-acquired bacterial pneumonia \[HABP\]) based on the difference in all-cause mortality rates in the intent to treat (ITT) population using a non-inferiority margin of 10%. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
An AE was defined as 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. The percentage of participants experiencing any AE was reported for each arm.
An SAE was defined as any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event. The percentage of participants with any SAE was reported for each arm.
A drug-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention. The percentage of participants with any drug related AEs was reported for each arm.
A drug-related SAE was defined any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event, that is considered related to the study intervention. The percentage of participants with any drug related SAEs was reported for each arm.
An AE was defined as 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. The percentage of participants with AEs leading to discontinuation of study intervention was reported for each arm.
| Arm | Type | Description |
|---|---|---|
| Ceftolozane/Tazobactam + Metronidazole | EXPERIMENTAL | Participants receive ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam may be adjusted to 500 mg/250 mg if creatinine clearance \[CrCL\] is 30 to ≤50 mL/min) |
| Meropenem + Placebo | ACTIVE_COMPARATOR | Participants receive meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem may be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). |
| Ceftolozane/tazobactam | EXPERIMENTAL | Participants receive 3000 mg ceftolozane/tazobactam intravenous IV (comprising 2000 mg ceftolozane and 1000 mg tazobactam) every 8 hours for 8-14 days. |
| Meropenem | ACTIVE_COMPARATOR | Participants receive 1000 mg meropenem IV every 8 hours for 8-14 days. |
| Meropenem + Placebo for Metronidazole | ACTIVE_COMPARATOR | Meropenem 20 mg/kg (maximum 1 g/dose) plus placebo for Metronidazole administered IV every 8 hours for 5 to 14 days. |
| Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age | EXPERIMENTAL | Participants 12 to \<18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age | EXPERIMENTAL | Participants 7 to \<12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age | EXPERIMENTAL | Participants 2 to \<7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age | EXPERIMENTAL | Participants 3 months to \<2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age | EXPERIMENTAL | Participants from birth to \<3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Name | Type | Description |
|---|---|---|
| Ceftolozane/Tazobactam | DRUG | Ceftolozane 1000 mg / tazobactam 500 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive ceftolozane 500 mg / tazobactam 250 mg. |
| Metronidazole | DRUG | Metronidazole 500 mg by IV infusion every 8 hours for 4 to 14 days. |
| Meropenem | DRUG | Meropenem 1000 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive IV infusion every 12 hours. |
| Placebo | DRUG | Saline by IV infusion every 8 hours for 4 to 14 days. |
| Placebo for Metronidazole | DRUG | Placebo for metronidazole administered IV every 8 hours for between 5 to 14 days. |
Inclusion Criteria: * Must have one of the following diagnoses in which there is evidence of bacterial intraperitoneal infection: Cholecystitis (including gangrenous cholecystitis) with rupture, perforation, or progression of the infection beyond the gallbladder wall; Acute gastric or small intesti...
Ceftolozane/Tazobactam is an investigational small molecule being developed for critically ill patients with proven or suspected Gram-negative bacterial infections, including complicated urinary tract infections, complicated intra-abdominal infections, nosocomial pneumonia, and healthcare-associated pneumonia. It is a combination antibiotic being studied in infectious disease.
Ceftolozane/Tazobactam is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug for various Gram-negative bacterial infections in both adult and pediatric populations.
Ceftolozane/Tazobactam is in Phase 2 clinical development. While one Phase 3 trial has been completed, the drug's overall development stage is Phase 2, and it remains investigational. It is not FDA approved and is still undergoing clinical evaluation for its safety and efficacy.
Ceftolozane/Tazobactam has been studied in several completed trials, including NCT02070757 for ventilated nosocomial pneumonia, NCT03217136 for pediatric complicated intra-abdominal infection, NCT03230838 for pediatric complicated urinary tract infection, and NCT04223752 for pediatric nosocomial pneumonia. These trials enrolled a total of 726 participants.
Yes, Ceftolozane/Tazobactam is also known as MK-7625A. Clinical trial titles reference MK-7625A, such as NCT03217136 and NCT03230838, which study the drug in pediatric patients with complicated intra-abdominal and urinary tract infections.