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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство chlorination for water disinfection and surface disinfection
  * 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.
• Поведенческое infection prevention and control messaging
  Infection prevention and control guidance and messaging

Первичные конечные точки

• Possible serious bacterial infection in neonate [Срок оценки: From birth to 7 days post birth]
• Possible maternal sepsis [Срок оценки: From birth to 7 days post birth]
• Neonatal infection with at least one bacterial pathogen [Срок оценки: 7 days after birth]

Вторичные конечные точки (12)

• Any symptom or sign of infection in neonate [Срок оценки: From birth until 7 days post birth]
• Any symptom or sign of infection in mother [Срок оценки: From birth to 7 days post birth]
• Clinical diagnosis of sepsis in neonate [Срок оценки: From birth to 7 days post birth]
• Clinical diagnosis of sepsis in mother [Срок оценки: From birth to 7 days post birth]
• Neonatal mortality [Срок оценки: From birth to 28 days after birth]
• Maternal mortality [Срок оценки: From birth to 28 days after birth]
• Neonatal rectal colonization with at least one bacterial pathogen by culture [Срок оценки: 7 days after birth]
• Maternal rectal colonization with at least one bacterial pathogen by culture-based method [Срок оценки: 7 days postpartum]
• Number of clinically relevant antibiotic resistance genes (ARGs) detected in neonatal rectal swabs [Срок оценки: 7 days post birth]
• Rectal colonization with one or more antibiotic resistant bacteria (neonates) [Срок оценки: 7 days post birth]
• Rectal colonization with one or more antibiotic resistant bacteria (mothers) [Срок оценки: 7 days postpartum]
• Number of bacterial pathogens in rectal swabs (neonates) [Срок оценки: 7 days post birth]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of California, Berkeley — Berkeley

Kenya · 1 центр

• Kenya Medical Research Institute — Nairobi

Публикации

• 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
• 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

Идентификаторы

NCT: NCT06824350 · 2024-01-17100 · R01AI184756

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗