NCT02739997

Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013)

A Multicenter, Open-label, Noncomparative, Japanese Phase III Study to Assess the Efficacy and Safety of Ceftolozane/Tazobactam (MK-7625A) Used in Combination With Metronidazole in Japanese Patients With Complicated Intra-abdominal Infection.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) plus metronidazole 500 mg for the treatment of Complicated Intra-abdominal Infections (cIAI) in Japanese participants. Efficacy will be primarily assessed by clinical response defined as complete resolution or significant improvement in signs and symptoms of the index infection.

Conditions

• Intra-abdominal Infection
• Complicated Intra-abdominal Infection

Interventions

Type	Name	Description
DRUG	MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)	MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion
DRUG	metronidazole 500 mg	metronidazole 500 mg administered as an IV infusion

Timeline

• Start date: 2016-04-08
• Primary completion: 2017-07-28
• Completion: 2017-07-28
• First posted: 2016-04-15
• Last updated: 2018-08-09
• Results posted: 2018-07-12