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)

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.12345

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.678910

Who Is on the Research Team?

PO

Phelgona Otieno, PhD

Principal Investigator

Kenya Medical Research Institute

AJ

Amy J Pickering, PhD

Principal Investigator

University of California, Berkeley

LM

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)
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Multi-component chlorine interventionExperimental Treatment2 Interventions
Group II: ControlActive Control1 Intervention

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+

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

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.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.
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 ...
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 ...
Chemical Disinfectants | Infection ControlIn another study, chlorine dioxide solutions at either 600 ppm or 30 ppm killed Mycobacterium avium-intracellulare within 60 seconds after ...
Disinfection Profiling and Benchmarking: Technical GuidanceTemperature Effects on Chlorine and DBP Formation. Chlorine is more effective at higher water temperatures, which results in faster chemical reactions and.
About Water Disinfection with Chlorine and ChloramineChlorine or chloramine levels up to 4 milligrams per liter (mg/L), or 4 parts per million (ppm), are considered safe in drinking water. These ...
Safety Data SheetCorrosive liquids, n.o.s., (Chlorine Water Solution). Transport hazard class(es): None. Packing group: III. Environmental hazard: None.
Chlorine Disinfection BackgroundCaution: Chlorine chemicals are harsh, corrosive, and pose potential health risks to the operator if not handled properly. Always follow all ...
Disinfection Byproducts—Chlorination of Drinking WaterAdding chlorine to drinking water sources with bacteria and other harmful organisms makes the water safer to drink. When used correctly, chlorine kills or ...
Chloramines in Drinking Water | US EPAChloramines are disinfectants used to treat drinking water. Chloramines are most commonly formed when ammonia is added to chlorine to treat ...
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