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Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs

Study acronym: PACUTI
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Mar 10, 2023 to May 29, 2023
    v5
  2. Start date: Jan 10, 2023 to Mar 10, 2023
    • Eligibility criteria expanded, about 163 words
    • Secondary endpoints: 3 to 8
    v4
  3. Primary completion date: Sep 1, 2026 to Sep 1, 2027v3 Show 4 more changesShow less
    • Start date: Sep 1, 2022 to Jan 10, 2023
    • Interventions: Pivmecillinam and amoxicillin/clavulanic acid (Drug), Standard treatment, ciprofloxacin or trimethoprim/sulfamethoxazole depending on… to Pivmecillinam and amoxicillin/clavulanic acid (Drug), Standard treatment, ciprofloxacin, trimethoprim/sulfamethoxazole or ertapenem…
    • Eligibility criteria shortened, about 13 words
    • Study description expanded, about 1 word
  4. Interventions: Pivmecillinam and amoxicillin/clavulanic acid (Drug) to Pivmecillinam and amoxicillin/clavulanic acid (Drug), Standard treatment, ciprofloxacin or trimethoprim/sulfamethoxazole depending on…
    • Eligibility criteria revised
    • Study description shortened, about 24 words
    • Publications: 1 to 2
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).
Trial Details
NCT Number NCT05224401
Lead Sponsor Lund University
Conditions
(from sponsor)		 Urinary Tract Infections, Bacteremia, Antibiotic Resistant Infection
Related terms Bacteremia, Urinary Tract Infections
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov