IMIPENEM AND CILASTATIN

DRUG3 trials

Sponsors

Uppsala Universitet, Spero Therapeutics Inc., Centre Hospitalier Universitaire De Nimes

Conditions

Serious infections in critically ill patients treated with antibioticscomplicated 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

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