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Cilastatin

DRUG5 trials

Sponsors

Evopoint Biosciences USA Inc., The University Of Queensland, Wyeth is now a wholly owned subsidiary of Pfizer, Merck Sharp & Dohme LLC, Spherium Biomed

Conditions

Bacterial PneumoniaDose Finding StudyHospital-acquired bacterial pneumonia (HABP)Mycobacterium abscessus pulmonary diseaseincluding ventilated HABP (vHABP) and ventilator-associated bacterial pneumonia (VABP) caused by Gram-negative bacteria

Phase 1

Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.
CompletedNCT03595189
Spherium BiomedDose Finding Study
Start: 2018-06-19End: 2018-08-09Updated: 2018-10-09

Phase 2

Finding the Optimal Regimen for Mycobacterium abscessus Treatment
RecruitingCTIS2023-506575-99-00
The University Of QueenslandMycobacterium abscessus pulmonary disease
Start: 2023-01-02Target: 20Updated: 2025-10-13

Phase 3

Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
CompletedNCT00080496
Wyeth is now a wholly owned subsidiary of PfizerBacterial Pneumonia
Start: 2003-07-31End: 2006-12-31Target: 430Updated: 2008-08-04
Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)
CompletedNCT02493764
Merck Sharp & Dohme LLCBacterial Pneumonia
Start: 2015-11-24End: 2019-04-03Updated: 2020-04-16
A Multicenter, Randomized, Double-Blind, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin-XNW4107 in Comparison with Imipenem/Cilastatin/Relebactam in Adults with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
CompletedCTIS2022-501952-27-00
Evopoint Biosciences USA Inc.Hospital-acquired bacterial pneumonia (HABP), including ventilated HABP (vHABP) and ventilator-associated bacterial pneumonia (VABP) caused by Gram-negative bacteria
Start: 2024-04-19End: 2024-07-26Target: 58Updated: 2024-08-21

Related Papers

Imipenem/cilastatin/relebactam dosing regimen justification using exposure-efficacy analyses in participants with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia in the RESTORE-IMI 2 phase 3 study.
2026-01-26
Participant- and Disease-Related Factors as Independent Predictors of Treatment Outcomes in the RESTORE-IMI 2 Clinical Trial: A Multivariable Regression Analysis
Open Forum Infectious Diseases2023-05-043 citations
Population pharmacokinetic/pharmacodynamic assessment of imipenem/cilastatin/relebactam in patients with hospital‐acquired/ventilator‐associated bacterial pneumonia
Clinical and Translational Science2021-10-2730 citations
A Randomized, Double-blind, Multicenter Trial Comparing Efficacy and Safety of Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam in Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study)
Clinical Infectious Diseases2020-07-06211 citations