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

NCT04836208 | Unknown

• 1 other identifier: 2020-059
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enterobacteriaceae Infections

Keywords

new born; intra-domiciliary transmission; community; Madagascar

Outcome Measures

Primary Outcomes (3)

• Number of acquisition events and the number of non-acquisition of E-ESBL in newborns for the epidemiological part

  Identification of bacterial strains from stool and sequencing of EBSL-E strains

  2 years

• Number of semi-structured interviews completed for the anthropological part

  1 or 4 hours semi-structured interviews of participants at home done by investigators

  2 years

• Number of participant direct observation completed for the anthropological part

  observations of the participants at home done by investigators (2 to 4 hours in 3 to 4 sessions over 28 days)

  2 years

Eligibility Criteria

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

Study Population

1. epidemiological study All members of 60 households in which a newborn baby has just been born 2. anthropological study with interviews 16 homes will be selected from among the 60 homes included: 8 homes (no ESBL-E) and 8 homes (ESBL-E). Interviews will be carried out with: 16 mothers 4 people with a mothering role on the child 4 minors in the families 4 fathers Also, interviews will be done with: Health actors: medical and traditional, 1 community health worker 1 neighborhood chief 3\) anthropological study with observations 4 households in total among the 16 initially selected for the interviews: 2 households (no ESBL-E) and 2 households (ESBL-E)

You may qualify if:

• For the epidemiological study :
• All members of 60 households in which a newborn baby has just been born
• \_ having a monofetal pregnancy
• residing regularly in the study area OR planning to reside in the study area during the study period;
• having been informed of the research and collection of biological samples on herself and her newborn;
• having given its agreement to carry out the research and the associated collection of biological samples, and;
• having signed the informed consent (or its witness if applicable).
• living after childbirth;
• whose parents or legal representatives present:
• reside regularly in the study area or plan to reside in the study area during the study period;
• were informed of the research and the associated collection of biological samples on their newborn;
• have given their agreement to carry out the research and the associated collection of biological samples,
• from the same household as the mother-child (ren) couple included
• Residing at least 4 nights per week in this home
• Having given its agreement to carry out the research and the associated collection of biological samples,

You may not qualify if:

• For the epidemiological part:
• Pregnant woman: non-monofetal pregnancy
• Newborn: died during childbirth
• Household resident: None
• and 3) For the anthropological part: • Semi-structured interview:
• For household members:
• not responding to the structural family and social functions of the child's environment For health workers and district managers
• people not meeting the targeted functions
• not practicing in the district of homes included
• Participant direct observation:
• Not living in the same household as the mother-child couple included

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut Pasteur de Madagascar: collaborator
• Centre hospitalier de référence du District de Moramanga: collaborator

Study Sites (1)

Institut Pasteur de Madagascar

Antananarivo, Madagascar

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* stool * milk for the mother of the new born

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Bich-Tram Huynh

  Institut Pasteur

  STUDY DIRECTOR

Central Study Contacts

Bich-Tram Huynh, MD

CONTACT

+33 1 45 68 83 01; bich-tram.huynh@pasteur.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: April 30, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 7, 2022

Record last verified: 2022-09

Locations

MA (1)