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)

• Status: Completed
• Trial end date: 2017-06-15
• Target enrollment: 0
• Participant gender: All

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 cohorts, an interim analysis of pharmacokinetics (PK) and safety data was conducted after approximately 3 participants had received the initially proposed dose. The interim analysis was to determine whether the initial dose was appropriate based on pre-defined criteria. If data from the interim analysis demonstrated that the initially proposed dose met the above criteria, enrollment was to continue with the same dose administered to approximately 3 additional participants of the same age range. However, if the interim analysis demonstrated that a new optimized dose was required, the new dose was to be administered to approximately 3 additional participants of the same age range.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Anti-Bacterial Agents; Ceftolozane; Ceftolozane, tazobactam drug combination; Cephalosporins; Penicillanic Acid; Tazobactam

Criteria

Key Inclusion Criteria:

1. Males or non-pregnant females from birth to <18 years of age

2. Receiving standard of care antibiotic therapy for suspected or diagnosed Gram-negative infection or for peri-operative prophylaxis

3. Groups 1-4: Calculated creatinine clearance rate (CLCR) ≥ 80 ml/min/1.73m2 at baseline

4. Group 5: CLCR ≥ 50 ml/min/1.73m2 at baseline

5. Group 6: CLCR ≥ 20 ml/min/1.73m2 at baseline

Key Exclusion Criteria:

1. Known allergy/hypersensitivity to any β-lactam antibacterial

2. History of clinically significant renal, hepatic, or hemodynamic instability

3. Planned use of cardiopulmonary bypass or dialysis

4. Planned blood transfusion within 24 hours of study drug administration

5. Clinically significant abnormal laboratory test results not related to the underlying infection

6. Receipt of piperacillin/tazobactam within 24 hours of study drug administration

7. Likely to be at risk of hemodynamic disturbance following collection of the required PK blood samples