NCT06824350 Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
| NCT ID | NCT06824350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Berkeley |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 45,450 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45,450 participants in total. It began in 2025-01-21 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Facility Inclusion Criteria: * Public health care facility * 25 live births or more per month * Infrastructure compatible with inline chlorination device Participant Inclusion Criteria: * Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates Facility Exclusion Criteria: * Existing facility-level chlorination Participant Exclusion Criteria: * Miscarriage (\<28 weeks gestation) * Stillbirth (for neonatal analysis only) * Unable to give informed consent/do not consent * Reside \>2 hours away from facility for enrollment into swab sampling cohort
Contact & Investigator
Amy J Pickering, PhD
PRINCIPAL INVESTIGATOR
University of California, Berkeley
Frequently Asked Questions
Who can join the NCT06824350 clinical trial?
This trial is open to participants of all sexes, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06824350 currently recruiting?
Yes, NCT06824350 is actively recruiting participants. Contact the research team at amyjanel@gmail.com for enrollment information.
Where is the NCT06824350 trial being conducted?
This trial is being conducted at Berkeley, United States, Nairobi, Kenya.
Who is sponsoring the NCT06824350 clinical trial?
NCT06824350 is sponsored by University of California, Berkeley. The principal investigator is Amy J Pickering, PhD at University of California, Berkeley. The trial plans to enroll 45,450 participants.