An observational study in Enterobacteriaceae Infections, sponsored by Institut Pasteur. Status unknown at 1 site in Madagascar. Per ClinicalTrials.gov, last updated 2022-10-07.
Sponsored by Institut Pasteur · Observational
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.
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:
This study is divided in two parts :
59 studies on the registry are indexed under Enterobacteriaceae Infections; 14 are open to participants now.
This study's planned enrollment of 600 is above the median of 300 across 30 observational studies indexed under Enterobacteriaceae Infections.
Browse Enterobacteriaceae Infections studies →Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.
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epidemiological study
All members of 60 households in which a newborn baby has just been born
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Inclusion criteria for the live newborn at the time of childbirth, new born :
Inclusion criteria for the household member, resident:
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 :
For health workers and district managers, inclusion criteria for semi-structured interviews :
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
Exclusion Criteria:
For the epidemiological part:
For household members:
not practicing in the district of homes included
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: 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
Time frame: 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)
Time frame: 2 years
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Enterobacteriaceae Infections →