NCT03830333

Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)

A Phase 3, Multicenter, Double-blind, Randomized, Active-controlled Clinical Study to Evaluate the Efficacy and Safety of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Chinese Participants With Complicated Intra-abdominal Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of ceftolozane/tazobactam (MK-7625A) plus metronidazole versus meropenem in adults diagnosed with complicated intra-abdominal infection (cIAI). The primary hypothesis is ceftolozane/tazobactam plus metronidazole is non-inferior to meropenem, as measured by the clinical response rate at the Test-of Cure (TOC) visit in the Clinically Evaluable (CE) population.

Conditions

• Complicated Intra-abdominal Infections

Interventions

Type	Name	Description
DRUG	Ceftolozane/Tazobactam	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.
DRUG	Metronidazole	Metronidazole 500 mg by IV infusion every 8 hours for 4 to 14 days.
DRUG	Meropenem	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.
DRUG	Placebo	Saline by IV infusion every 8 hours for 4 to 14 days.

Timeline

• Start date: 2019-03-20
• Primary completion: 2020-10-14
• Completion: 2020-10-14
• First posted: 2019-02-05
• Last updated: 2023-01-17
• Results posted: 2021-10-22

Locations

25 sites across 1 country: China

Regulatory

• FDA-regulated drug study