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

NCT06824350 | Recruiting DMC

• 2 other identifiers: 2024-01-17100R01AI184756
• Study Type: interventional
• Target: 45,450
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Sepsis; Neonatal Mortality; Antibiotic Resistant Infection; Enteric Infections; Serious Bacterial Infection

Keywords

infection prevention and control; antibiotic resistance; bacterial enteric infection; neonatal mortality; sepsis; water disinfection; chlorine; sodium hypochlorite; hospital acquired infections

Outcome Measures

Primary Outcomes (3)

• Possible serious bacterial infection in neonate

  Incidence of one or more of the following severe infection symptoms of neonates based on WHO criteria for possible serious bacterial infection: 1. Not able to feed at all or not feeding well 2. Convulsions 3. Severe chest indrawing 4. Fever - High body temperature (38°C\* or above) 5. Low body temperature (less than 35.5°C\*) 6. Movement only when stimulated or no movement at all 7. Fast breathing (60 breaths per minute or more)

  From birth to 7 days post birth

• Possible maternal sepsis

  Any of the following listed with fever or hypothermia: 1. fast heartbeat 2. low blood pressure 3. respiratory distress 4. jaundice 5. decreased urination/dysuria 6. altered mental status

  From birth to 7 days post birth

• Neonatal infection with at least one bacterial pathogen

  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

  7 days after birth

Secondary Outcomes (13)

• Any symptom or sign of infection in neonate

  From birth until 7 days post birth

• Any symptom or sign of infection in mother

  From birth to 7 days post birth

• Clinical diagnosis of sepsis in neonate

  From birth to 7 days post birth

• Clinical diagnosis of sepsis in mother

  From birth to 7 days post birth

• Neonatal mortality

  From birth to 28 days after birth

Other Outcomes (10)

• Rectal colonization with individual bacterial pathogens (neonates)

  7 days post birth

• Rectal colonization with individual bacterial pathogens (mothers)

  7 days postpartum

• Presence of individual ARGs in neonatal rectal swabs

  7 days post birth

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Behavioral: infection prevention and control messaging

Multi-component chlorine intervention

EXPERIMENTAL

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.

Device: chlorination for water disinfection and surface disinfection; Behavioral: infection prevention and control messaging

Interventions

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.

Multi-component chlorine intervention

infection prevention and control messaging BEHAVIORAL

Infection prevention and control guidance and messaging

Control; Multi-component chlorine intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Public health care facility
• live births or more per month
• Infrastructure compatible with inline chlorination device
• Pregnant adults/mature minors arriving at enrolled facilities to give birth and their neonates

You may not qualify if:

• Existing facility-level chlorination
• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Kenya Medical Research Institute: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (2)

University of California, Berkeley

Berkeley, California, 94720, United States

ACTIVE NOT RECRUITING

Kenya Medical Research Institute

Nairobi, Kenya

RECRUITING

Related Publications (2)

• Lindmark M, Cherukumilli K, Crider YS, Marcenac P, Lozier M, Voth-Gaeddert L, Lantagne DS, Mihelcic JR, Zhang QM, Just C, Pickering AJ. Passive In-Line Chlorination for Drinking Water Disinfection: A Critical Review. Environ Sci Technol. 2022 Jul 5;56(13):9164-9181. doi: 10.1021/acs.est.1c08580. Epub 2022 Jun 14.

  PMID: 35700262 BACKGROUND

• Pickering AJ, Crider Y, Sultana S, Swarthout J, Goddard FG, Anjerul Islam S, Sen S, Ayyagari R, Luby SP. Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial. Lancet Glob Health. 2019 Sep;7(9):e1247-e1256. doi: 10.1016/S2214-109X(19)30315-8.

  PMID: 31402005 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy J Pickering, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

• Phelgona Otieno, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

• Lillian Musila, PhD

  Walter Reed Army Institute of Research-Africa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy J Pickering, PhD

CONTACT

1-510-410-2666; amyjanel@gmail.com

Yoshika Crider, PhD

CONTACT

1-785-550-5227; ycrider@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Lab technicians will be masked to intervention status of samples received. A subset of investigators will be masked to outcomes by intervention status until data collection is complete.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

KE (1); US (1)