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IMIPENEM AND CILASTATIN

DRUG4 trials

Sponsors

Uppsala Universitet, Spero Therapeutics Inc., Centre Hospitalier Universitaire De Nimes, Assistance Publique Hopitaux De Paris

Conditions

Serious infections in critically ill patients treated with antibioticsWomen aged 75 years or older presenting with E. coli pyelonephritiscomplicated urinary tract infection (cUTI) or acute pyelonephritis (AP)febrile Urinary Tract Infection (fUTI)

Phase 2

Pivmecillinam as oral step-down treatment for Escherichia coli febrile urinary tract infection versus standard of care; a randomized controlled non-inferiority multicenter trial
RecruitingCTIS2023-503447-33-00
Uppsala Universitetfebrile Urinary Tract Infection (fUTI)
Start: 2025-11-13Target: 560Updated: 2025-10-08

Phase 3

A Phase 3, randomized, double-blind, double-dummy, multicenter, multinational study to assess the efficacy and safety of orally administered tebipenem pivoxil hydrobromide (TBP-PI-HBr) compared to intravenously (IV) administered imipenem-cilastatin in patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)
CompletedCTIS2023-503785-22-00
Spero Therapeutics Inc.complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)
Start: 2024-03-25End: 2025-05-28Target: 1454Updated: 2025-06-09
FOSFOLD - Fosfomycin trometamol compared with another active antibiotic relay therapy for the treatment of acute Escherichia coli pyelonephritis in elderly women: a randomized, multicenter, non-inferiority trial
Not yet recruitingCTIS2025-521663-13-00
Assistance Publique Hopitaux De ParisWomen aged 75 years or older presenting with E. coli pyelonephritis
Target: 312Updated: 2026-08-21

Phase 4

Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol - A multi-national pharmacokinetic/pharmacodynamic cohort study to determine whether contemporary antibiotic dosing for critically ill patients achieves therapeutic exposures.
Not yet recruitingCTIS2024-516232-10-00
Centre Hospitalier Universitaire De NimesSerious infections in critically ill patients treated with antibiotics
Target: 200Updated: 2025-10-17