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Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 18, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jul 1, 2025 to Dec 31, 2025v5 Show 4 more changesShow less
    • Start date: Sep 21, 2023 to Nov 27, 2023
    • Enrollment target: 360 to 404
    • Study completion date: Nov 30, 2025 to Dec 31, 2025
    • Secondary endpoints revised (8)
  2. Study sites: 14 to 15
    • Eligibility criteria shortened, about 39 words
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 30, 2023 to Sep 21, 2023
    • Site details revised at 14 of 14 sites
    v3
  4. Start date: Sep 30, 2023 to Oct 30, 2023
    • Secondary endpoints revised (8)
    • Study sites revised (14)
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin, however in another group, the patients accept treatment without colistin. The efficacy and safety of the treatment between the two groups are compared.
Trial Details
NCT Number NCT06051513
Lead Sponsor Southeast University, China
Conditions
(from sponsor)		 Carbapenem-Resistant Enterobacteriaceae Infection
Related terms Healthcare-Associated Pneumonia, Sepsis
Enrollment 404 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov