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NCT06824350 · ClinicalTrials.gov registry record · NA
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
A NA study of Sepsis and Antibiotic Resistant Infection, sponsored by University of California, Berkeley.
- Recruiting
- Registry status
- NA
- Development phase
- 45,450
- Enrollment target
- 2
- Study locations
NCT06824350: Recruiting NA study of Sepsis and Antibiotic Resistant Infection, sponsored by University of California, Berkeley.
NCT06824350 is a NA study of Sepsis and Antibiotic Resistant Infection that is actively recruiting participants, run by University of California, Berkeley. The registered enrollment target is 45,450 participants, above the 6,060-participant average among 90 other Sepsis trials with a reported enrollment target (650% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06824350, a NA study of Sepsis and Antibiotic Resistant Infection, is actively recruiting participants, sponsored by University of California, Berkeley.
- RECRUITING
- Registry status
- NA
- Development phase
- 45,450 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Incidence of one or more of the following severe infection symptoms of neonates based on WHO criteria for possible serious bacterial infection: 1. Not able to feed at all or not feeding well 2. Convulsions 3. Severe chest indrawing 4. Fever - High body temperature (38°C\* or above) 5. Low body temperature (less than 35.5°C\*) 6. Movement only when stimulated or no movement at all 7. Fast breathing (60 breaths per minute or more)
Conditions Studied
Interventions
- DEVICE chlorination for water disinfection and surface disinfection
- BEHAVIORAL infection prevention and control messaging
Study Locations (2)
California
- University of California, Berkeley - Berkeley
Other
- Kenya Medical Research Institute - Nairobi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45,450 participants |
| Start Date | 2025-01-21 |
| Est. Completion | 2027-07 |
| Phase | NA |
What NCT06824350 shows while recruiting
NCT06824350 is an interventional study that assigns participants to a tested intervention. Its 45,450 participants enrollment target places it among the larger protocols in the corpus, above the 6,060-participant average among 90 other Sepsis trials with a reported enrollment target (650% higher).
The record links to 5 conditions, with Sepsis appearing as the primary indexed condition, and to 2 interventions - of which chlorination for water disinfection and surface disinfection is the first listed.
NCT06824350 reports a single indexed study location in California, Other.
Frequently Asked Questions
What is clinical trial NCT06824350 about?
NCT06824350 is a clinical study titled "Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates". 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 ...
What is the current status of trial NCT06824350?
This trial is currently recruiting. It is a NA study. The enrollment target is 45,450 participants. The study started on 2025-01-21. Estimated completion is 2027-07.
What conditions does trial NCT06824350 study?
This clinical trial studies the following conditions: Sepsis, Antibiotic Resistant Infection, Neonatal Mortality, Enteric Infections, Serious Bacterial Infection.
What interventions are being tested in trial NCT06824350?
The interventions under investigation include: chlorination for water disinfection and surface disinfection (DEVICE), infection prevention and control messaging (BEHAVIORAL).
Who is sponsoring clinical trial NCT06824350?
This trial is sponsored by University of California, Berkeley, which has 72 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06824350 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06824350's enrollment target sits among peer trials
45,450 4th of 90 higher than 87 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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