Enterobacteriaceae InfectionsNeoLICNCT04836208
Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC
An observational study of Enterobacteriaceae Infections, run by Institut Pasteur at 1 site in Madagascar.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Enterobacteriaceae Infections
- How many people
- 600 participants
- Where
- 1 siteMadagascar
- Study dates
- 30 Apr 2021to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 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;
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- 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,
- 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)
- 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
- 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)
- 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)
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
Madagascar1 site, 1 recruiting
- Recruiting
Institut Pasteur de Madagascar
Antananarivo
Aina HARIMANANA, MD, aharim@pasteur.mg
Aina Rakotondrasoa, PhD, +261 34 98 185 32, aina@pasteur.mg
About this study
Official title: Neonatal Acquisition of ESBL-PE in a Low-income Country
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.
Read the 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
- Keywords
- new born, intra-domiciliary transmission, community, Madagascar
- Medical subject headings
- Enterobacteriaceae Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start30 Apr 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterobacteriaceae InfectionsStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Madagascar, Centre hospitalier de référence du District de Moramanga
- Responsible party
- Sponsor
- Investigators
- Bich-Tram Huynh, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836208
- Sponsor's protocol ID
- 2020-059
- Acronym
- NeoLIC
- Status last verified
- Sep 2022
- First submitted
- 31 Mar 2021
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Acquisition of ESBL-PE in a Low-income Country
- ClinicalTrials.gov ID
- NCT04836208
- Acronym / sponsor ID
- NeoLIC / 2020-059
- Conditions
- Enterobacteriaceae Infections
- Keywords
- new born, intra-domiciliary transmission, community, Madagascar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Madagascar, Centre hospitalier de référence du District de Moramanga
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (34 listed)
- For the epidemiological study :
- All members of 60 households in which a newborn baby has just been born
- having a monofetal pregnancy
- 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
- 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
Key exclusion criteria (11 listed)
- For the epidemiological part:
- and 3) For the anthropological part: • Semi-structured interview:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of acquisition events and the number of non-acquisition of E-ESBL in newborns for the epidemiological part
Time frame: 2 years
Identification of bacterial strains from stool and sequencing of EBSL-E strains
Number of semi-structured interviews completed for the anthropological part
Time frame: 2 years
1 or 4 hours semi-structured interviews of participants at home done by investigators
Number of participant direct observation completed for the anthropological part
Time frame: 2 years
observations of the participants at home done by investigators (2 to 4 hours in 3 to 4 sessions over 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bich-Tram Huynh study director
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterobacteriaceae Infections, run by Institut Pasteur at 1 site in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bich-Tram Huynh, MD (+33 1 45 68 83 01, bich-tram.huynh@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acquisition events and the number of non-acquisition of E-ESBL in newborns for the epidemiological part (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.