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Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens

Study acronym: CLEMENT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Dec 2026 → Aug 2027
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 69% 176 → 55 participants
See other at-risk trials from Beneficência Portuguesa de São Paulo

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Aug 2027 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reduced: 176 → 55 participants
    • Study completion pushed from Dec 2026 to Dec 2027
    • Secondary endpoints: details revised at 5 of 10 entries
    • Collaborators: details revised at 1 of 1 entry
    • Publications: details revised at 16 of 16 entries
    • Eligibility criteria expanded, about 4 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Apr 2025 to Dec 2026
    • Start date changed from estimate of Oct 2024 to Mar 26, 2025
    • Site details revised
    v3
  3. Start date: Jun 2024 to Oct 2024v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is: \- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection. Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes.
Trial Details
NCT Number NCT06342115
Lead Sponsor Beneficência Portuguesa de São Paulo
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Febrile Neutropenia
Related terms Febrile Neutropenia
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov