Chlorination for Infections

(CLEAN Trial)

Recruiting at 1 trial location

Overseen By Amy J Pickering, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Berkeley

Disqualifiers: Miscarriage, Stillbirth, Consent, Distance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

45450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how using chlorine in healthcare facilities can improve the health of mothers and newborns in western Kenya. The researchers aim to determine if chlorinating water and cleaning surfaces can reduce infections in maternity wards, focusing on gut bacteria that might cause serious infections in newborns and their mothers. Facilities in the trial will receive equipment and supplies for water and surface disinfection, along with guidance on preventing infections. Pregnant women planning to give birth at participating facilities and their newborns are the primary participants. This study targets public healthcare facilities with at least 25 births a month and suitable infrastructure for chlorination. As an unphased trial, it offers participants the chance to contribute to important research that could enhance healthcare practices and outcomes for mothers and newborns.

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 prior data suggests that this chlorination intervention is safe for maternal and neonatal health?

Research has shown that using chlorine to clean water and surfaces is generally safe. Studies indicate that chlorine levels up to 4 milligrams per liter (or 4 parts per million) are safe for drinking water. When used correctly, chlorine can kill harmful germs without posing a health risk to those who drink the water.

However, chlorine can be strong and irritating if not used properly. Contact with large amounts can cause skin or eye irritation. In the small amounts used for cleaning water and surfaces, it remains safe and effective.

Overall, using chlorine to clean water and surfaces is common and helps reduce infections. It is important to follow safety guidelines when handling chlorine to avoid irritation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to infection prevention through the use of chlorination in healthcare settings. Unlike traditional methods that often rely on manual disinfection processes, this trial tests an automated system that chlorinates water directly at the source. Additionally, the trial investigates the effectiveness of producing chlorine on-site versus receiving bulk deliveries, offering potential flexibility and efficiency in maintaining hygiene standards. This innovative approach could significantly enhance infection control practices by ensuring consistent and reliable disinfection, potentially reducing infection rates in maternity wards.

What evidence suggests that this multi-component chlorination intervention is effective for reducing infections in neonates and their mothers?

This trial will compare a multi-component chlorine intervention with a control group. Studies have shown that chlorine effectively disinfects both water and surfaces. It is widely used in North America to make water safe to drink and kills many types of bacteria and germs. Chlorine-based cleaners have successfully reduced harmful bacteria on surfaces, helping to prevent infections. Research also shows that chlorine solutions can kill certain bacteria in just 60 seconds, making it a powerful tool for stopping infections. Overall, chlorine's proven ability to disinfect both water and surfaces makes it a strong option for improving the health of mothers and newborns by reducing the risk of bacterial infections. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy J Pickering, PhD

Principal Investigator

University of California, Berkeley

Phelgona Otieno, PhD

Principal Investigator

Kenya Medical Research Institute

Lillian Musila, PhD

Principal Investigator

Walter Reed Army Institute of Research-Africa

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Multi-component chlorine intervention Experimental Treatment 2 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: Control Active Control 1 Intervention

Control group. At the conclusion of the trial, facilities will receive a chlorine doser.

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+

Published Research Related to This Trial

Higher concentrations of disinfectants are required to effectively degrade Legionella biofilms and prevent their formation on plastic surfaces compared to the concentrations needed to kill Legionella bacteria in culture.

The study used monospecies biofilms of three strains of Legionella pneumophila grown on plastic plates, highlighting the importance of testing disinfectants in conditions that mimic real-world biofilm scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of bactericidal activity of disinfectants against Legionella on the biofilm model]. Dronina, IuE., Panteleeva, LG., Karpova, TI., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Waterborne outbreak control: which disinfectant? Akin, EW., Hoff, JC., Lippy, EC.[2018]

Combining UV treatment with chlorine or chlorine dioxide significantly reduces Escherichia coli levels in drinking water systems more effectively than using chlorine-based disinfectants alone, as shown in a study using eight reactors.

Despite the effectiveness of UV and chlorine combinations, E. coli can adapt and persist under certain conditions, highlighting the need for improved disinfection strategies to ensure safe drinking water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential UV- and chlorine-based disinfection to mitigate Escherichia coli in drinking water biofilms. Murphy, HM., Payne, SJ., Gagnon, GA.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conditions of inactivation of viruses in water with chlorination]. Nestor, I.[2013]

Chlorination of public drinking water significantly reduced waterborne diseases since the early 1900s, but it also led to the formation of harmful chlorinated by-products, such as chloroform, which prompted regulatory measures.

Recent studies have identified numerous other chlorinated by-products, including the potent bacterial mutagen MX and chlorinated acetic acids, raising concerns about their potential health risks and the need for thorough risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in research on carcinogenic and genotoxic by-products of chlorine disinfection: chlorinated hydroxyfuranones and chlorinated acetic acids. Daniel, FB., Meier, JR., Deangelo, AB.[2012]

A population-based case-control study using Arkansas birth records found no significant increase in the risk of hypospadias associated with exposure to disinfection by-products (DBPs) like trihalomethanes (THM) and haloacetic acids (HAA) during pregnancy.

While some intermediate exposure levels showed a potential association with hypospadias, the overall evidence was weak, highlighting the importance of individual-level data in assessing the risks of DBP exposure during gestation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal exposure to water disinfection by-products during gestation and risk of hypospadias. Luben, TJ., Nuckols, JR., Mosley, BS., et al.[2013]

Chlorination has been a highly effective public health measure for controlling waterborne diseases for nearly a century, but it produces disinfection by-products (DBPs) that raise safety concerns, particularly trihalomethanes (THMs) and haloacetates.

Alternatives to chlorination exist, but their safety and effectiveness are less understood, which could lead to greater public health risks if not applied correctly; thus, the hazards of chlorination must be carefully evaluated against these alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water chlorination: essential process or cancer hazard? Bull, RJ., Birnbaum, LS., Cantor, KP., et al.[2019]

Chlorination of drinking water has significantly reduced typhoid fever mortality since its introduction, but it is not sufficient alone to prevent water-mediated disease outbreaks, as pathogens can still survive in fecal particles.

Filtration is essential for effectively removing pathogens from drinking water, as disinfection alone cannot ensure safety from fecal contamination; both methods should be used together for optimal water hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of disinfection in suppressing the spread of pathogens with drinking water: possibilities and limitations. Schoenen, D.[2019]

From 1993 to 2000, there was a decline in chlorine release events, but these incidents were significantly more likely to cause harm, requiring evacuations and decontaminations compared to other hazardous substance releases.

Most victims of chlorine exposure experienced respiratory and eye irritation, with the main causes being equipment failure and human error, highlighting the need for ongoing employee training and maintenance to prevent such incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The public health consequences from acute chlorine releases, 1993-2000. Horton, DK., Berkowitz, Z., Kaye, WE.[2019]

Chlorination has been the standard method for disinfecting drinking water in the U.S. for 75 years, but it can produce potentially harmful trihalomethanes (THMs) like chloroform, raising health concerns.

Chlorine dioxide is a potential alternative that does not generate THMs, but while it has shown some toxicity in animal studies, there is currently no clear evidence of adverse health effects in humans, including those undergoing hemodialysis, suggesting that with proper precautions, risks may be minimal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorine dioxide and hemodialysis. Smith, RP., Willhite, CC.[2019]

Hospitals using monochloramine for drinking water disinfection had significantly fewer outbreaks of Legionnaires' disease compared to those using free chlorine, with an odds ratio of 10.2, indicating a strong protective effect.

The study suggests that if monochloramine had been used instead of free chlorine, up to 90% of Legionnaires' disease outbreaks could have been prevented, highlighting the potential for monochloramine to be a cost-effective solution for reducing these infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of monochloramine disinfection of municipal drinking water on risk of nosocomial Legionnaires' disease. Kool, JL., Carpenter, JC., Fields, BS.[2016]

Enterobacter cloacae, when attached to drinking water distribution particles, showed increased resistance to chlorination, highlighting a potential risk for water safety.

The degree of protection from disinfection was influenced by the chlorine concentration and the duration of attachment, suggesting that longer attachment times could enhance the risk of coliform outbreaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attachment as a factor in the protection of Enterobacter cloacae from chlorination. Herson, DS., McGonigle, B., Payer, MA., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence Map and Systematic Review of Disinfection Efficacy on Environmental Surfaces in Healthcare Facilities. Christenson, EC., Cronk, R., Atkinson, H., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32442652/

A systematic review of chlorine-based surface disinfection ...

This review highlights that surface disinfection efficacy estimates are strongly influenced by each study's experimental conditions.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0196655320303114

A systematic review of chlorine-based surface disinfection ...

Reported chlorine disinfection efficacy outcomes against the 7 selected pathogens with potential to cause outbreaks in low-resource settings are summarized in ...

3.

tandfonline.com

tandfonline.com/doi/full/10.1080/10643389.2025.2538881

A systematic literature review for selected water treatment ...

Chlorine is the most common disinfectant for water treatment in North America and based on the SWTR, C × T values are defined for protozoan and ...

4.

cdc.gov

cdc.gov/infection-control/hcp/disinfection-sterilization/chemical-disinfectants.html

Chemical Disinfectants | Infection Control

In another study, chlorine dioxide solutions at either 600 ppm or 30 ppm killed Mycobacterium avium-intracellulare within 60 seconds after ...

5.

epa.gov

epa.gov/system/files/documents/2022-02/disprof_bench_3rules_final_508.pdf

Disinfection Profiling and Benchmarking: Technical Guidance

Temperature Effects on Chlorine and DBP Formation. Chlorine is more effective at higher water temperatures, which results in faster chemical reactions and.

6.

cdc.gov

cdc.gov/drinking-water/about/about-water-disinfection-with-chlorine-and-chloramine.html

About Water Disinfection with Chlorine and Chloramine

Chlorine or chloramine levels up to 4 milligrams per liter (mg/L), or 4 parts per million (ppm), are considered safe in drinking water. These ...

7.

fishersci.com

fishersci.com/store/msds?partNumber=S25247&productDescription=fisher-science-educationtrade-chlorine-water&vendorId=VN00115888&keyword=true&countryCode=US&language=en

Safety Data Sheet

Corrosive liquids, n.o.s., (Chlorine Water Solution). Transport hazard class(es): None. Packing group: III. Environmental hazard: None.

8.

health.state.mn.us

health.state.mn.us/communities/environment/water/docs/ncom/chlordisbackground.pdf

Chlorine Disinfection Background

Caution: Chlorine chemicals are harsh, corrosive, and pose potential health risks to the operator if not handled properly. Always follow all ...

9.

doh.wa.gov

doh.wa.gov/community-and-environment/drinking-water/disinfection/disinfection-byproducts

Disinfection Byproducts—Chlorination of Drinking Water

Adding chlorine to drinking water sources with bacteria and other harmful organisms makes the water safer to drink. When used correctly, chlorine kills or ...

10.

epa.gov

epa.gov/dwreginfo/chloramines-drinking-water

Chloramines in Drinking Water | US EPA

Chloramines are disinfectants used to treat drinking water. Chloramines are most commonly formed when ammonia is added to chlorine to treat ...