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Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates

Study acronym: CLEAN
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 3 → 5 primary endpoints
See other at-risk trials from University of California, Berkeley

Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: 13 to 25
    • Publications: 2 to 3
  2. Enrollment target: 70700 to 45450
    • Study description revised
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care facilities on maternal and neonatal health. Intervention facilities will receive a passive chlorination technology for water supply treatment and a reliable supply of sodium hypochlorite disinfectant. Both intervention and treatment facilities will receive infection prevention and control messaging. The goal of the study is to evaluate the impact of the intervention on bacterial contamination of water supply, on staff hands, and on high-touch surfaces in maternity wards, and the following outcomes among facility-born neonates and their mothers: (1) gut carriage of bacterial pathogens associated with sepsis one week post-birth, (2) gut carriage of antibiotic resistant bacteria one week post-birth, and (3) symptoms of possible serious bacterial infection one week following birth.
Trial Details
NCT Number NCT06824350
Lead Sponsor University of California, Berkeley
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Kenya Medical Research Institute, Walter Reed Army Institute of Research (WRAIR)
Conditions
(from sponsor)		 Sepsis, Neonatal Mortality, Antibiotic Resistant Infection, Enteric Infections, Serious Bacterial Infection
Related terms Sepsis
Enrollment 45,450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov