Chlorination for Infections
(CLEAN Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAmy J Pickering, PhD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Berkeley
Disqualifiers: Miscarriage, Stillbirth, Consent, Distance, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
14111213Eligibility 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)
+2 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of California, BerkeleyBerkeley, CA
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Who Is Running the Clinical Trial?
University of California, BerkeleyLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
Kenya Medical Research InstituteCollaborator
Walter Reed Army Institute of Research (WRAIR)Collaborator
References
[Conditions of inactivation of viruses in water with chlorination]. [2013]Spread within the environment, especially in water, of enteral pathogens has stimulated the greatest interest and raised many problems that have not yet been fully elucidated. Of particular importance is the possibility of inactivating enteroviruses by chlorinating water. The antiviral disinfection of water by chlorination has proved efficient under the conditions mentioned, lowering the incidence of water-borne viral diseases.
Evidence Map and Systematic Review of Disinfection Efficacy on Environmental Surfaces in Healthcare Facilities. [2023]Healthcare-associated infections (HAIs) contribute to patient morbidity and mortality with an estimated 1.7 million infections and 99,000 deaths costing USD $28-34 billion annually in the United States alone. There is little understanding as to if current environmental surface disinfection practices reduce pathogen load, and subsequently HAIs, in critical care settings. This evidence map includes a systematic review on the efficacy of disinfecting environmental surfaces in healthcare facilities. We screened 17,064 abstracts, 635 full texts, and included 181 articles for data extraction and study quality assessment. We reviewed ten disinfectant types and compared disinfectants with respect to study design, outcome organism, and fourteen indictors of study quality. We found important areas for improvement and gaps in the research related to study design, implementation, and analysis. Implementation of disinfection, a determinant of disinfection outcomes, was not measured in most studies and few studies assessed fungi or viruses. Assessing and comparing disinfection efficacy was impeded by study heterogeneity; however, we catalogued the outcomes and results for each disinfection type. We concluded that guidelines for disinfectant use are primarily based on laboratory data rather than a systematic review of in situ disinfection efficacy. It is critically important for practitioners and researchers to consider system-level efficacy and not just the efficacy of the disinfectant.
Waterborne outbreak control: which disinfectant? [2018]Drinking water disinfection was shown to be an important public health measure around the turn of the century. In the United States, it was perhaps the single most important factor in controlling typhoid fever, a waterborne disease that was rampant throughout the world during the last century. It may also be assumed that disinfection was important in limiting the number of cases of other diseases known to be capable of waterborne transmission, i.e., cholera, amebiasis, shigellosis, salmonellosis, and hepatitis A. Even though modern treatment has eliminated water as a major vehicle of infectious disease transmission, outbreaks still occur. In fact, the annual number has been increasing since 1966. Interruption in chlorination or failure to achieve adequate levels of chlorine residual is the most often identified deficiency of the involved water supplies. This finding indicates that waterborne microbial pathogens remain as a potential health threat and underscores the importance of disinfection. From the outset, chlorination has been the drinking water disinfectant of choice in the country. Numerous studies have demonstrated its ability to inactivate bacterial, viral, and protozoal pathogens when applied under proper conditions. However, the finding that chlorinated organics that are potentially carcinogenic are formed has prompted an evaluation of alternative disinfectants. The viable alternatives to chlorine currently under consideration for widespread use are ozone, chlorine dioxide, and chloramines. In terms of biocidal efficiency, ozone is the most potent of the three. Chlorine dioxide is about the equivalent of free chlorine in the hypochlorous acid form but much more efficient than the hypochlorite form of free chlorine. The chloramines are weaker biocides than hypochlorite. Although this general order of ranking of efficiency holds for diverse types of microorganisms, quantitative comparisons vary with different microorganisms and experimental conditions.
Effect of monochloramine disinfection of municipal drinking water on risk of nosocomial Legionnaires' disease. [2016]Many Legionella infections are acquired through inhalation or aspiration of drinking water. Although about 25% of municipalities in the USA use monochloramine for disinfection of drinking water, the effect of monochloramine on the occurrence of Legionnaires' disease has never been studied.
Sequential UV- and chlorine-based disinfection to mitigate Escherichia coli in drinking water biofilms. [2013]This study was designed to examine the potential downstream benefits of sequential disinfection to control the persistence of Escherichia coli under conditions relevant to drinking water distribution systems. Eight annular reactors (four polycarbonate and four cast iron) were setup in parallel to address various factors that could influence biofilm growth in distribution systems. Eight reactors were treated with chlorine, chlorine dioxide and monochloramine alone or in combination with UV to examine the effects on Escherichia coli growth and persistence in both the effluent and biofilm. In general, UV-treated systems in combination with chlorine or chlorine dioxide and monochloramine achieved greater log reductions in both effluent and biofilm than systems treated with chlorine-based disinfectants alone. However, during UV-low chlorine disinfection, E. coli was found to persist at low levels, suggesting that the UV treatment had instigated an adaptive mutation. During UV-chlorine-dioxide treatment, the E. coli that was initially below the detection limit reappeared during a low level of disinfection (0.2 mg/L) in the cast iron systems. Chloramine was shown to be effective in disinfecting suspended E. coli in the effluent but was unable to reduce biofilm counts to below the detection limit. Issues such as repair mechanism of E. coli and nitrification could help explain some of these aberrations. Improved understanding of the ability of chlorine-based disinfectant in combination with UV to provide sufficient disinfection will ultimately effect in improved management and safety of drinking water.
Advances in research on carcinogenic and genotoxic by-products of chlorine disinfection: chlorinated hydroxyfuranones and chlorinated acetic acids. [2012]The introduction of chlorination of public drinking water in the early 1900's was a major factor in the fight against waterborne disease. In the 1970's it was discovered that chlorine reacted with naturally occurring organic constituents, particularly in surface water, to yield small quantities of chlorinated by-products such as chloroform for which regulations were subsequently developed. Since then there has been shown to be a substantial number of other by-products some in concentrations of a few nanograms/l and others similar concentrations to the THM. Of particular note are the potent bacterial mutagen MX and the chlorinated acetic acids. Current research into the significance of these for man is described and the key issues for risk assessment are identified.
The public health consequences from acute chlorine releases, 1993-2000. [2019]Chlorine, a commonly used hazardous substance, can be harmful to human health when improperly released. Data from the Agency for Toxic Substances and Disease Registry's Hazardous Substances Emergency Events Surveillance system were used to conduct a retrospective analysis on the public health consequences from acute chlorine release in 16 states during 1993 through 2000. There was an overall decline in the number of chlorine events during the period analyzed; however, chlorine events were more likely to result in events with victims, evacuations, and decontaminations when compared with nonchlorine events (relative risk [RR] = 4.5, 95% confidence interval [CI] = 4.1 to 5.0; [RR] = 4.8, CI 4.3 to 5.3; and [RR] = 2.0, CI 1.7 to 2.4, respectively). Most chlorine victims were employees and members of the general public. The predominant symptoms sustained were respiratory and eye irritation. Equipment failure and human error were the most frequent factors leading to an event. Continuous employee training and preventive equipment maintenance can help prevent chlorine releases from occurring and minimize exposure to the general public.
Maternal exposure to water disinfection by-products during gestation and risk of hypospadias. [2013]The use of chlorine for water disinfection results in the formation of numerous contaminants called disinfection by-products (DBPs), which may be associated with birth defects, including urinary tract defects.
Water chlorination: essential process or cancer hazard? [2019]Chlorine has been successfully used for the control of waterborne infectious disease for nearly a century. In the 1970s it was found that chlorine reacted with natural organic matter present in surface waters to produce disinfection by-products (DBP). Concern focused initially on the trihalomethanes (THM), but a wide variety of DBPs are now known to result from chlorination. Chlorination of drinking water has been one of the most effective public health measures ever undertaken. There are a number of alternatives to chlorination that are in active use in many parts of the world, but the risks associated with their by-products are even less well established than for chlorination. Moreover, the use of these alternatives vary in their effectiveness and some require greater sophistication in their application. This can mean less protection to public health as a result of inappropriate application and control. Therefore, hazards associated with the use of such a clearly beneficial process as chlorination must be carefully considered not only in an absolute sense, but also in the context of alternative approaches for producing a safe drinking water. The key question is whether the hazards associated with by-products have been sufficiently well established to warrant regulations that will undoubtedly have both positive and negative impacts on the public health. This symposium examined the toxicological and epidemiological data on chemical hazards associated with chlorination and attempted to measure this hazard against competing microbial risks. The first presentation discussed the available analytical epidemiological studies. A second presentation dealt with the importance of chlorination to the prevention of waterborne infectious disease. Pharmacokinetic, mechanistic, and modeling information on the prototypical DBP, chloroform, were discussed and contrasted with data on brominated THMs to determine if it was scientifically appropriate to regulate THMs as a single toxicological class. The fifth presentation dealt with the carcinogenic properties of a potent mutagen that is produced by chlorination. The final presentation discussed the haloacetates, carcinogenic DBPs whose concentrations approach and occasionally exceed those of the THMs. Clearly, there is a need to carefully weigh these different types and sometimes competing risks when considering the delivery of drinking water to ever-increasing populations for which there are finite sources of fresh water.
Chlorine dioxide and hemodialysis. [2019]In the United States chlorination of potable water supplies has been the standard method of disinfection for about 75 years. In recent times concern has been raised about the propensity of chlorination to introduce potentially carcinogenic trihalomethanes (THM) such as chloroform into finished water. The levels of THM introduced depend on many factors including the quality of the raw water. Numerous community water treatment facilities are experiencing difficulty in meeting current U.S. Environmental Protection Agency standards, and it is likely that the permissible levels may be lowered in the future. An alternative to chlorination which does not generate THM during disinfection is chlorine dioxide, but there are concerns about the acute and chronic toxicity of ClO2 and its disinfection by-products, chlorite and chlorate. Deleterious effects of moderately high levels of these oxychlorines have been demonstrated experimentally on red blood cells, thyroid function, and development in laboratory animals. Adverse effects in controlled prospective studies in humans and in actual use situations in community water supplies have as yet failed to reveal clear evidence of adverse health effects. Among groups who may be at special risk from this suggested alternative are patients who must undergo chronic extracorporeal hemodialysis. The special needs, precautions, and experience to date in regard to finished water are reviewed. Again, very limited human experience has failed to reveal adverse health effects. Further study, caution, and extreme vigilance are indicated, but dialysis patients in carefully controlled facilities may be at no greater risk than the general population.
Role of disinfection in suppressing the spread of pathogens with drinking water: possibilities and limitations. [2019]Transmission of pathogens with drinking water is a widespread problem, which affects not only the countries with low hygienic standards but the industrialized countries as well. The pathogens are excreted by man or animals and are picked up orally. Chlorination of drinking water has been introduced to the water supply in the beginning of the 19th century in order to stop the spreading of pathogens especially typhoid fever by drinking water. Despite the worldwide use of chlorine for disinfection of drinking water, water-mediated disease outbreaks occur again and again. Disinfection of drinking water with chlorine has undoubtedly contributed to the reduction of typhoid fever mortality. However, it must be clear that other factors play an important role in the mortality drop. Filtration of water is a long-known and very effective process for eliminating pathogens from the drinking water. Pathogens in particles cannot be killed sufficiently by a chemical disinfectant. Even small fecal particles have to be eliminated reliably from the water by filtration. Disinfection of drinking water cannot replace filtration. The disinfection should be used to minimize the residual risk due to the presence of pathogens in the water but cannot be used for bringing fecally contaminated water into a hygienically sound condition.
[Assessment of bactericidal activity of disinfectants against Legionella on the biofilm model]. [2020]Comparative assessment of bactericidal activity of different disinfectants against Legionella biofilms was conducted. Monospecies biofilms of 3 strains of Legionella pneumophila obtained on plastic plates in stable conditions were used as models. It has been shown that for degradation of biofilms as well as for prophylactic action of disinfectants in preventing formation of biofilms on plastic surfaces, higher concentrations of preparations were needed as compared to their bactericidal concentrations for culture of Legionella determined by method of serial dilutions.
Attachment as a factor in the protection of Enterobacter cloacae from chlorination. [2021]Enterobacter cloacae attached to drinking water distribution particles was subjected to chlorination. Attachment resulted in the protection of these organisms from disinfection. This effect was found to be dependent upon both the level of chlorine in the system and attachment time. The results obtained in this study indicate that attached organisms may play an important role in coliform outbreaks.