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

University of California (UC), Berkeley

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT06824350

2024-01-17100

R01AI184756 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45,450 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45,450 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: infection prevention and control messaging

Multi-component chlorine intervention

Experimental group

Description:

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.

Treatment:

Device: chlorination for water disinfection and surface disinfection

Behavioral: infection prevention and control messaging