45450 Participants Needed

Chlorination for Infections

(CLEAN Trial)

Recruiting at 1 trial location
YC
AJ
Overseen ByAmy J Pickering, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Berkeley
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

LM

Lillian Musila, PhD

Principal Investigator

Walter Reed Army Institute of Research-Africa

AJ

Amy J Pickering, PhD

Principal Investigator

University of California, Berkeley

PO

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

Facility: Public health care facility with 25 live births or more per month and infrastructure compatible with inline chlorination device
I am pregnant or a new parent at the enrolled facility.

Exclusion Criteria

Facility: Existing facility-level chlorination
Participant: Miscarriage (<28 weeks gestation)
Participant: Stillbirth (for neonatal analysis only)
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of multi-component chlorination intervention in health care facilities, including passive chlorination technology and sodium hypochlorite disinfectant supply

24 months
Quarterly visits for data collection

Follow-up

Participants are monitored for symptoms of possible serious bacterial infection and other health outcomes

7 days post birth for neonates, 28 days post birth for mothers

Data Collection

Quarterly data collection on water quality, surface contamination, and healthcare worker hand hygiene

24 months
Quarterly visits

Treatment Details

Interventions

  • Chlorination for water disinfection and surface disinfection
  • Infection prevention and control messaging
Trial Overview This study tests whether using chlorine for water treatment and surface disinfection in health care settings can lower bacterial contamination and infection rates among newborns and mothers.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Multi-component chlorine interventionExperimental Treatment2 Interventions
Health care facilities will receive one or more inline chlorine dosers that will automatically chlorinate all water accessed by the maternity wards. Intervention facilities will also be randomized to either receive an electrochlorinator for on-site production of liquid chlorine solution or to receive bulk chlorine deliveries. Chlorine will be use to refill the chlorine dosers and for surface disinfection. Facilities will also receive hardware to facilitate surface disinfection.
Group II: ControlActive Control1 Intervention
Control group. At the conclusion of the trial, facilities will receive a chlorine doser.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials
193
Recruited
716,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Kenya Medical Research Institute

Collaborator

Trials
186
Recruited
1,408,000+

Walter Reed Army Institute of Research (WRAIR)

Collaborator

Trials
111
Recruited
108,000+

Findings from Research

Chlorination of water is an effective method for inactivating enteroviruses, which are a significant concern as enteral pathogens in the environment.
Using chlorination for water disinfection has been shown to reduce the incidence of water-borne viral diseases, highlighting its importance for public health.
[Conditions of inactivation of viruses in water with chlorination].Nestor, I.[2013]
Healthcare-associated infections (HAIs) are a significant issue, causing approximately 1.7 million infections and 99,000 deaths annually in the U.S., highlighting the urgent need for effective disinfection practices in healthcare settings.
The systematic review of 181 studies revealed that current guidelines for disinfectant use are largely based on laboratory data rather than real-world efficacy, indicating a need for improved research on the actual effectiveness of disinfection practices in reducing pathogen load in critical care environments.
Evidence Map and Systematic Review of Disinfection Efficacy on Environmental Surfaces in Healthcare Facilities.Christenson, EC., Cronk, R., Atkinson, H., et al.[2023]
Chlorination has been a crucial method for disinfecting drinking water, significantly reducing waterborne diseases like typhoid fever, but interruptions in chlorination can lead to outbreaks, highlighting the ongoing need for effective disinfection.
While chlorine remains the primary disinfectant, alternatives like ozone, chlorine dioxide, and chloramines are being evaluated due to concerns about carcinogenic byproducts from chlorination, with ozone being the most effective biocide among them.
Waterborne outbreak control: which disinfectant?Akin, EW., Hoff, JC., Lippy, EC.[2018]

References

[Conditions of inactivation of viruses in water with chlorination]. [2013]
Evidence Map and Systematic Review of Disinfection Efficacy on Environmental Surfaces in Healthcare Facilities. [2023]
Waterborne outbreak control: which disinfectant? [2018]
Effect of monochloramine disinfection of municipal drinking water on risk of nosocomial Legionnaires' disease. [2016]
Sequential UV- and chlorine-based disinfection to mitigate Escherichia coli in drinking water biofilms. [2013]
Advances in research on carcinogenic and genotoxic by-products of chlorine disinfection: chlorinated hydroxyfuranones and chlorinated acetic acids. [2012]
The public health consequences from acute chlorine releases, 1993-2000. [2019]
Maternal exposure to water disinfection by-products during gestation and risk of hypospadias. [2013]
Water chlorination: essential process or cancer hazard? [2019]
Chlorine dioxide and hemodialysis. [2019]
Role of disinfection in suppressing the spread of pathogens with drinking water: possibilities and limitations. [2019]
12.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Assessment of bactericidal activity of disinfectants against Legionella on the biofilm model]. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Attachment as a factor in the protection of Enterobacter cloacae from chlorination. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity