NCT02266706View on ClinicalTrials.gov

Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

September 17, 2014

Primary Completion Date

June 8, 2017

Study Completion Date

June 15, 2017

Conditions
Proven or Suspected Gram-negative Bacterial InfectionPeri-operative Prophylaxis
Interventions
DRUG

Ceftolozane/Tazobactam 1000/500 mg

A fixed dose combination (FDC) of 1000 mg ceftolozane and 500 mg tazobactam as a 60 minute infusion.

DRUG

Ceftolozane/Tazobactam 30/15 mg/kg

A FDC of 30 mg/kg of ceftolozane and 15 mg/kg of tazobactam as a 60 minute infusion.

DRUG

Ceftolozane/Tazobactam 20/10 mg/kg

A FDC of 20 mg/kg of ceftolozane and 10 mg/kg of tazobactam as a 60 minute infusion.

DRUG

Ceftolozane/Tazobactam 18/9 mg/kg

A FDC of 18 mg/kg of ceftolozane and 9 mg/kg of tazobactam as a 60 minute infusion.

DRUG

Ceftolozane/Tazobactam 12/6 mg/kg

A FDC of 12 mg/kg of ceftolozane and 6 mg/kg of tazobactam as a 60 minute infusion.

All Listed Sponsors
lead

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

NCT02266706 - Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010) | Biotech Hunter | Biotech Hunter