NCT03293485

Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) in Japanese Participants With Complicated Intra-abdominal Infection or Complicated Urinary Tract Infection (MK-7655A-017)

A Phase III Non-randomized, Non-controlled, Open Label Clinical Trial to Study the Safety and Efficacy of Imipenem/Cilastatin/Relebactam (IMI/REL [MK-7655A]) in Japanese Subjects With Complicated Intra-Abdominal Infection (cIAI) or Complicated Urinary Tract Infection (cUTI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL, MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI).

Conditions

• Complicated Intra-abdominal Infection
• Complicated Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Imipenem+Cilastatin/Relebactam	Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours

Timeline

• Start date: 2017-10-04
• Primary completion: 2018-09-14
• Completion: 2018-09-14
• First posted: 2017-09-26
• Last updated: 2021-02-12
• Results posted: 2019-09-17

Locations

29 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study