NCT04836208

Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC

Neonatal Acquisition of ESBL-PE in a Low-income Country

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Enterobacteriaceae, more specifically Escherichia coli and Klebsiella pneumoniae, are the bacteria most often responsible for neonatal infections in low-income countries. Infections caused by multidrug-resistant Enterobacteriaceae: Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E), are more often associated with an unfavorable outcome of the infection. Enterobacteriaceae colonize the digestive tract which is the first step in developing a potential infection. Very few studies have been carried out at the community level. Colonization of the mother with ESBL-E is generally considered to be a major route of acquisition. The carrying of ESBL-E by other family members and other potential sources of transmission (food, objects and surfaces in contact with the newborn) have never been documented. In addition, with a view to offering an intervention adapted to the local context, the local cultural determinants which govern the interactions of the newborn with his environment are important to understand.

Detailed description

This is a single-center prospective cohort of all members living in the same household in which a newborn baby has just been born. The study consists to: * recruit a cohort of all members of 60 households in which a newborn has just been born * carry out semi-structured interviews and direct participant observation. This study is divided in two parts : * the epidemiological part : the documentation of colonization by E-ESBL by sampling the stools of the newborn, of all members of the household, and sampling of food given to the child, from surfaces in contact with it. * the anthropological part : Semi-structured interviews with key people in the structuring of the social and family environment of the newborn and participant direct observation of households.

Conditions

• Enterobacteriaceae Infections

Timeline

• Start date: 2021-04-30
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2021-04-08
• Last updated: 2022-10-07

Locations

1 site across 1 country: Madagascar