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NCT Number: NCT06824350

Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates

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.

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Key information

Conditions

Sepsis Antibiotic Resistant Infection Enteric Infections Infections Inflammation Neonatal Mortality Pathologic Processes Pathological Conditions, Signs and Symptoms Serious Bacterial Infection Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute, Nairobi, Kenya

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About this study

The proportion of births occurring at healthcare facilities is rising globally, yet healthcare facilities in low-income settings have been found to be highly contaminated with bacterial pathogens, including antibiotic resistant pathogens. There is a need for effective strategies to reduce contamination in healthcare facilities in order to reduce infection risks among facility-born neonates. In this trial, medium-sized public health facilities will be randomized to control or to receive an intervention consisting of passive chlorination for water supply treatment and a reliable supply of chlorine disinfectant. Reliable supply is randomized as either (a) an electrochlorinator for on-site production or (b) bulk chlorine delivery.

This cluster randomized controlled trial will enroll 36 health facilities to generate rigorous evidence on the maternal and neonatal health benefits of chlorinated water supply paired with reliable supplies of chlorine disinfectant. This study has the following aims: 1) determine the impact of the intervention on pathogenic and antibiotic resistant bacterial contamination in water supplies, on high-touch surfaces, and on healthcare worker hands, 2) quantify intervention effects on gut colonization of mothers and neonates by a panel of pathogenic and antibiotic resistant bacteria species linked to serious infection, using molecular and culture-based methods, and 3) follow up with mother-neonate dyads to measure intervention effects on symptoms of possible serious bacterial infection in the week following birth. Data collection will be for a duration of 24 months.

Infection prevention through effective water, sanitation, and hygiene (WASH) has been cited by national action plans as a key tool in the fight against antimicrobial resistance and, while global data show dire WASH conditions in low- and middle-income (LMIC) health facilities, there exists very little guidance for implementing effective interventions. The overarching goal is to generate actionable evidence to inform investments in chlorination at health facilities to improve maternal and neonatal health and reduce the threat of antibiotic resistant infections.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Facility Inclusion Criteria:

  • Public health care facility
  • 25 live births or more per month
  • Infrastructure compatible with inline chlorination device

Participant Inclusion Criteria:

  • Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates

Facility Exclusion Criteria:

  • Existing facility-level chlorination

Participant Exclusion Criteria:

  • Miscarriage (<28 weeks gestation)
  • Stillbirth (for neonatal analysis only)
  • Unable to give informed consent/do not consent
  • Reside >2 hours away from facility for enrollment into swab sampling cohort

Treatment and study plan

chlorination for water disinfection and surface disinfection

Device
  • Installation of inline chlorine doser(s) for automated water disinfection.
  • Provision of chlorine solution for water and surface disinfection (half of treatment facilities randomized to receive electrochlorinator, half receive bulk chlorine solution deliveries).
  • Provision of mop(s), bucket(s), and spray bottles for surface cleaning.

infection prevention and control messaging

Behavioral

Infection prevention and control guidance and messaging

Primary outcomes

  1. Possible serious bacterial infection in neonate

    Time frame: From birth to 7 days post birth

    Incidence of one or more of the following severe infection symptoms of neonates based on WHO criteria for possible serious bacterial infection:

    • Not able to feed at all or not feeding well
    • Convulsions
    • Severe chest indrawing
    • Fever - High body temperature (38°C* or above)
    • Low body temperature (less than 35.5°C*)
    • Movement only when stimulated or no movement at all
    • Fast breathing (60 breaths per minute or more)

  2. Possible maternal sepsis

    Time frame: From birth to 7 days post birth

    Any of the following listed with fever or hypothermia:

    • fast heartbeat
    • low blood pressure
    • respiratory distress
    • jaundice
    • decreased urination/dysuria
    • altered mental status

  3. Neonatal infection with at least one bacterial pathogen

    Time frame: 7 days after birth

    Detection of any pre-specified bacterial pathogen detected by qPCR in infant rectal swabs (among swab subset of participants)

    Includes:

    ETEC, STEC, EPEC, EAEC, EIEC, EHEC O157:H7, Escherichia coli/Shigella, Shigella spp, Shigella flexneri, Salmonella spp., Salmonella enteritidis, Salmonella typhi, Campylobacter jejuni/coli, Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Streptococcus agalactiae (Group B strep), Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter baumannii, Clostridium difficile, Vibrio cholerae

Secondary outcomes

  1. Any symptom or sign of infection in neonate

    Time frame: From birth until 7 days post birth

    One or more of the following symptoms:

    Difficulty feeding, Hyperthermia/fever, Hypothermia, Tachypnea, Severe chest indrawing, Convulsions, Movement only when stimulated/no movement, Bulging fontanel, Labored breathing, Skin infection, Umbilical redness, Oozing ears, Diarrhea, Three or more loose or watery stools in a 24 hour period, Vomiting, Cyanosis, Cough, Runny nose or congestion, Tachycardia (>160 bpm at rest)

  2. Any symptom or sign of infection in mother

    Time frame: From birth to 7 days post birth

    One or more of the following symptoms:

    Hypothermia, Fever, Foul smelling vaginal discharge, Fits/convulsions, Tachycardia (>100 bpm at rest), Low blood pressure, Diarrhea (self-defined), Difficulty breathing, Jaundice, Decreased urination or difficult or painful urination, Confusion or altered mental state, Mastitis, Chills, Body aches, Low appetite, Lower abdominal pain, Three or more loose or watery stools in a 24 hour period, Vomiting, Cough, Runny nose or congestion, Chest pain, Bloody stool, Skin infection

  3. Clinical diagnosis of sepsis in neonate

    Time frame: From birth to 7 days post birth

    Abstracted diagnosis from medical charts OR self-reported diagnosis confirmed by clinician

  4. Clinical diagnosis of sepsis in mother

    Time frame: From birth to 7 days post birth

    Abstracted diagnosis from medical charts OR self-reported diagnosis confirmed by clinician

  5. Neonatal mortality

    Time frame: From birth to 28 days after birth

    Report of neonatal death up to 28 days

  6. Maternal mortality

    Time frame: From birth to 28 days after birth

    Report of maternal death

  7. Neonatal rectal colonization with at least one bacterial pathogen by culture

    Time frame: 7 days after birth

    Detection of any pre-specified bacterial pathogen detected by culture in neonate rectal swabs (among swab subset of participants)

    Includes:

    Acinetobacter spp., Pseudomonas spp., Salmonella spp., Shigella, Staphylococcus aureus, Group B streptococcus

  8. Maternal rectal colonization with at least one bacterial pathogen by culture-based method

    Time frame: 7 days postpartum

    Detection of any pre-specified bacterial pathogen detected by culture in maternal rectal swabs (among swab subset of participants)

    Acinetobacter spp., Pseudomonas spp., Salmonella spp., Shigella spp., Staphylococcus aureus, Group B streptococcus

  9. Number of clinically relevant antibiotic resistance genes (ARGs) detected in neonatal rectal swabs

    Time frame: 7 days post birth

    Measured by qPCR. Includes: resistance to quinolone, macrolide, sulfonamide, tetracycline, vancomycin, aminoglycoside, beta-lactams (cephalosporin, penicillin, ampicillin) , carbapenem, colistin

  10. Rectal colonization with one or more antibiotic resistant bacteria (neonates)

    Time frame: 7 days post birth

    Detection of ESBL enterobacteriaceae by culture in rectal swabs

    Includes: Klebsiella spp./Enterobacter/Citrobacter spp. (KEC), Acinetobacter spp., Pseudomonas spp., E. coli

  11. Rectal colonization with one or more antibiotic resistant bacteria (mothers)

    Time frame: 7 days postpartum

    Detection of ESBL enterobacteriaceae by culture in rectal swabs

    Includes: Klebsiella spp./Enterobacter/Citrobacter spp. (KEC), Acinetobacter spp., Pseudomonas spp., E. coli

  12. Number of bacterial pathogens in rectal swabs (neonates)

    Time frame: 7 days post birth

    Number of unique bacterial pathogens (see pre-specified list above) detected by qPCR

  13. Number of bacterial pathogens in rectal swabs (mothers)

    Time frame: 7 days postpartum

    Number of unique bacterial pathogens (see pre-specified list above) by culture

Other outcomes

  1. Rectal colonization with individual bacterial pathogens (neonates)

    Time frame: 7 days post birth

    Detection of individual bacterial pathogen by qPCR or by culture (see list in secondary outcomes)

  2. Rectal colonization with individual bacterial pathogens (mothers)

    Time frame: 7 days postpartum

    Detection of individual bacterial pathogen (see pre-specified list in secondary outcomes) by culture or qPCR

  3. Presence of individual ARGs in neonatal rectal swabs

    Time frame: 7 days post birth

    Presence/absence of pre-specified clinically relevant ARGs by qPCR

  4. Presence and concentration of bacterial pathogens on high touch surfaces

    Time frame: Measured quarterly over 24 months post intervention delivery (every 3 months)

    Measured by culture-based assays

    Includes: Acinetobacter spp., Pseudomonas spp., Salmonella spp., Shigella, Staphylococcus aureus, Group B streptococci

  5. Presence and concentration of antibiotic resistant bacterial pathogens on high touch surfaces

    Time frame: Measured quarterly over 24 months post intervention delivery (every 3 months)

    Detection of ESBL enterobacteriaceae by culture in surface swabs

    Includes: Klebsiella spp./Enterobacter/Citrobacter spp. (KEC), Acinetobacter spp., Pseudomonas spp., E. coli

  6. Proportion of water samples meeting WHO "safe" criteria

    Time frame: Measured quarterly over 24 months post intervention delivery (every 3 months)

    Measured as <1 CFU E. coli per 100ml water tested by culture

  7. Concentration of E. coli / 100 ml water

    Time frame: Measured quarterly over 24 months post intervention delivery (every 3 months)

    Measured by culture-based membrane filtration assay

  8. Presence and concentration of E. coli and total coliform on healthcare staff hands

    Time frame: Measured quarterly over 24 months post intervention delivery (every 3 months)

    Measured by membrane filtration culture assay

  9. Presence and concentration of antibiotic resistant bacterial pathogens on healthcare staff hands

    Time frame: Measured quarterly over 24 months post intervention delivery (every 3 months)

    Detection of ESBL enterobacteriaceae by culture in hand rinses and swabs

    Includes: Klebsiella spp./Enterobacter/Citrobacter spp. (KEC), Acinetobacter spp., Pseudomonas spp., E. coli

  10. Proportion of water supply samples with detectable free chlorine residual in water

    Time frame: Measured quarterly over 24 months post intervention delivery (every 3 months)

    Measured as >0.1 ppm by DPD method

Study contacts

Contact information is provided by the study sponsor or research team.

Amy J Pickering, PhD

CONTACT

[email protected]

1-510-410-2666

Yoshika Crider, PhD

CONTACT

[email protected]

1-785-550-5227

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Kenya Medical Research Institute
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Walter Reed Army Institute of Research (WRAIR)

Registry information

Official study title

Multi-component Chlorination Intervention to Reduce Neonatal Infections in Rural Health Facilities

Acronym: CLEAN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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