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

Enterobacteriaceae Infections Clinical Trial

— NeoLIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04836208
• Other study ID #: 2020-059
• Status: Recruiting
• Start date: April 30, 2021
• Est. completion date: May 2023

Study information

• Verified date: September 2022
• Source: Institut Pasteur
• Contact: Bich-Tram Huynh, MD
• Phone: +33 1 45 68 83 01
• Email: bich-tram.huynh[@]pasteur.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. For the epidemiological study :

All members of 60 households in which a newborn baby has just been born

Inclusion criteria for the mother at the time of childbirth, pregnant woman :

_ 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).

Inclusion criteria for the live newborn at the time of childbirth, new born :

• 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,

Inclusion criteria for the household member, resident:

• 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,

• and having signed the consent of the study (or its witness, or its legal representative if applicable)

2. for the anthropological study with interviews : 16 homes will be selected from among the 60 homes included: 8 homes in which the child has not acquired an ESBL-E during the entire follow-up and 8 homes in which the child has acquired an ESBL-E at least once during its follow-up. Among these households, interviews will be carried out with: 16 mothers or first responsible for the child in the absence of the mother 4 people with a mothering role on the child (grandmother, aunts ...) 4 minors in the families to observe 4 fathers or father figures in families to observe

Also, interviews will be done with:

Health actors: medical (1 midwife and 1 neighborhood doctor) and traditional (1 matron and 1 traditional practitioner from the neighborhood), 1 community health worker 1 neighborhood chief

Inclusion criteria for semi-structured interviews :

• people responding to the structuring functions of the child's social and family environment

• Having given its agreement to carry out the research,

• and having signed the consent of the study (or its witness, or its legal representative if applicable)

For health workers and district managers, inclusion criteria for semi-structured interviews :

• people responding to the targeted functions

• working in the district of homes included

• Having given its agreement to carry out the research,

• and having signed the consent of the study (or its witness, or its legal representative if applicable)

3. For the anthropological study with observations 4 households in total among the 16 initially selected for the interviews: 2 households in which the child did not acquire ESBL-E during all the follow-up and 2 households in which the child acquired at least once an BLSE-E during his follow-up Inclusion criteria for participating direct observations

• Residents of the same household as the mother-child (ren) couple included

• having agreed to participate in the study

• Having given its agreement to carry out the research,

• and having signed the consent of the study (or its witness, or its legal representative if applicable)

Exclusion Criteria:

1. For the epidemiological part:

• Pregnant woman: non-monofetal pregnancy

• Newborn: died during childbirth

• Household resident: None

2. 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

Related Conditions & MeSH terms

• Enterobacteriaceae Infections

Locations

Country	Name	City	State
Madagascar	Institut Pasteur de Madagascar	Antananarivo

Sponsors (3)

Lead Sponsor	Collaborator
Institut Pasteur	Centre hospitalier de référence du District de Moramanga, Institut Pasteur de Madagascar

Country where clinical trial is conducted

Madagascar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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