Status:
COMPLETED
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)
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Proven or Suspected Gram-negative Bacterial Infection
Peri-operative Prophylaxis
Eligibility:
All Genders
7-17 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants. In each of the 6 age...
Eligibility Criteria
Inclusion
- Key
- Males or non-pregnant females from birth to \<18 years of age
- Receiving standard of care antibiotic therapy for suspected or diagnosed Gram-negative infection or for peri-operative prophylaxis
- Groups 1-4: Calculated creatinine clearance rate (CLCR) ≥ 80 ml/min/1.73m2 at baseline
- Group 5: CLCR ≥ 50 ml/min/1.73m2 at baseline
- Group 6: CLCR ≥ 20 ml/min/1.73m2 at baseline
- Key
Exclusion
- Known allergy/hypersensitivity to any β-lactam antibacterial
- History of clinically significant renal, hepatic, or hemodynamic instability
- Planned use of cardiopulmonary bypass or dialysis
- Planned blood transfusion within 24 hours of study drug administration
- Clinically significant abnormal laboratory test results not related to the underlying infection
- Receipt of piperacillin/tazobactam within 24 hours of study drug administration
- Likely to be at risk of hemodynamic disturbance following collection of the required PK blood samples
Key Trial Info
Start Date :
September 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2017
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02266706
Start Date
September 17 2014
End Date
June 15 2017
Last Update
September 11 2019
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