Chlorination for Infections
(CLEAN Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Chlorination for water disinfection and surface disinfection in preventing infections?
Chlorination has been shown to effectively inactivate viruses and reduce the incidence of water-borne viral diseases, making it a valuable method for disinfecting water and preventing infections. Additionally, chlorination has historically been important in controlling waterborne diseases like typhoid fever, cholera, and hepatitis A, highlighting its role in infection prevention.12345
Is chlorination generally safe for humans?
Chlorination has been used for water disinfection for many years and is effective in preventing waterborne diseases. However, it can produce by-products that may pose health risks, such as respiratory and eye irritation, and potential links to cancer and birth defects. While these risks exist, they are generally considered low compared to the benefits of preventing infectious diseases.678910
How does chlorination for infections differ from other treatments?
Chlorination is unique because it focuses on disinfecting water and surfaces to prevent infections, rather than treating infections directly. It works by killing pathogens in water, which helps reduce the spread of diseases like typhoid fever and viral infections, making it different from treatments that target infections after they occur.14111213
What is the purpose of this trial?
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.
Research Team
Lillian Musila, PhD
Principal Investigator
Walter Reed Army Institute of Research-Africa
Amy J Pickering, PhD
Principal Investigator
University of California, Berkeley
Phelgona Otieno, PhD
Principal Investigator
Kenya Medical Research Institute
Eligibility Criteria
The CLEAN trial is for newborns and their mothers in western Kenya. It aims to reduce infections, including those resistant to antibiotics, by improving hygiene in healthcare facilities with chlorination interventions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Implementation of multi-component chlorination intervention in health care facilities, including passive chlorination technology and sodium hypochlorite disinfectant supply
Follow-up
Participants are monitored for symptoms of possible serious bacterial infection and other health outcomes
Data Collection
Quarterly data collection on water quality, surface contamination, and healthcare worker hand hygiene
Treatment Details
Interventions
- Chlorination for water disinfection and surface disinfection
- Infection prevention and control messaging
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Berkeley
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Kenya Medical Research Institute
Collaborator
Walter Reed Army Institute of Research (WRAIR)
Collaborator