Diarrhea ToddlersETEC-SurvNCT04838587
An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka
An observational study of Diarrhea Toddlers and Escherichia Coli Diarrhea, run by Centre for Infectious Disease Research in Zambia at 4 sites in Zambia.
Trial summary
Diarrhoea is the one of the top five leading causes of death among children below the age of five years, globally. It is estimated that one in ten deaths in children under five is attributed to diarrhoea. Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea Toddlers, Escherichia Coli Diarrhea
- How many people
- 6,828 participants
- Where
- 4 sitesZambia
- Study dates
- 15 Oct 2020to 15 Oct 2021
- 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 Up to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study is a multi-site longitudinal observation study, to be conducted at Matero First Level Hospital, Chawama First Level Hospital, George Clinic, Kanyama First Level Hospital and Chainda clinic in Lusaka. The facilities are situated in a typical peri-urban settlement area of Lusaka and serves a community with a combined population of about 1 million. We assume that all sites have similar incidence of ETEC diarrhoea, therefore, each of the 5 sites will enroll 1350 children bringing our total sample size for the study to 6,750 participants.
Who may be able to join
- A child < 36 months old at the time of enrolment.
- A child presenting with diarrhoea (i.e. > 3 episodes of looser than normal stools in 24 hours) at a health facility within the study catchment area and in possession of a study ID number.
- Parents of eligible children, able to understand the study information and give informed consent by signature or thumbprint. (NB. illiterate participants will be able to give consent in the presence of an impartial witness)
- Children living within the study catchment area served by each participating health facility and in possession of a study ID number
- The parent/s who is willing to comply with all stipulated study procedures.
- Parents who are willing to allow their child to submit a stool sample for testing.
Who cannot join
- Children presenting to the health facility without a study ID number
- Any child born after the Census has taken place
- Any child currently participating in the OEV124 study
Trial locations and contacts
4 sites in 1 country.
Zambia4 sites
Chawama First level hospital
Lusaka, 10101
George Clinic
Lusaka, 10101
Kanyama First Level Hospital
Lusaka, 10101
Matero Clinical Research Site, Chainda South CRS
Lusaka, 10101
About this study
Official title: An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka.
Diarrhoea is the one of the top five leading causes of death among children below the age of five years, globally. It is estimated that one in ten deaths in children under five is attributed to diarrhoea. Enterotoxigenic E.coli (ETEC) is one of the major causative agents of moderate-to-severe (MSD) diarrhoea among children both globally and in Zambia.
The overall aim of this study is to document the burden of ETEC associated diarrhoea in Zambian children under 3 years of age.
Read the detailed description
This study seeks to determine diarrhoea aetiology, calculate the incidence of moderate-to-severe ETEC-associated diarrhea, and describe the frequency of ETEC colonization factors and enterotoxin types in children under 3 years old in Zambia.
These data are required for the design of an anticipated phase 3 trial of the leading ETEC vaccine (ETVAX®) that will be evaluated in Zambia from 2021 onwards.
The following are the research questions that this study seeks to answer:
- What is the incidence of MSD with confirmed ETEC aetiology in children under three years old in Zambia?
- What are the prevalent colonization toxins and factors (CFs) in diarrhoeagenic isolates of ETEC infections in children in Zambia?
- What are the other common pathogens causing diarrhoea in Zambian children?
This prospective, observational, longitudinal study is proposed at five health facilities in Lusaka. The proposed study sites are Chawama, George, Kanyama, Chainda, and Matero Health Facilities. These facilities are located within typical peri-urban settlements of Lusaka and serves communities with a cumulative total population of over 1 million people. The study will be done in two stages beginning with a household census in the study catchment area of the participating health facilities and then followed by the passive diarrhoea surveillance stage. A surveillance system for passive case detection of diarrhoea will be set up at each facility for the 12-months of the project to detect any seasonal variations of disease burden. Prior to commencement, several community sensitization activities will be conducted within the catchment areas of the health facility.
A stool sample will be collected from each participant who presents to the health facility and is eligible for enrollment. All research samples will be collected at the study site and laboratory assays will be performed as per written SOPs and will be a part of the study documentation. All the samples will be processed in Zambia using the Novodiag® platform. The Novodiag® (Mobidiag Ltd, Finland) is a novel multiplex molecular platform that is based on real-time PCR and microarray technology and can identify various gastroenteritis causing bacteria, parasites and viruses as well as carry out antimicrobial resistance gene testing of organisms.
- Conditions
- Diarrhea Toddlers, Escherichia Coli Diarrhea
- Being tested
- No intervention will be done
- Keywords
- Incidence, Epidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be doneOther
No intervention,Only passive surveillance of Diarrhoea cases will be done
| Study group | Role | What they receive |
|---|---|---|
| 6750 Children <3 years ( 5 sites) | A total of 6750 children from the will be identified from the respective health facility catchment area during the Census stage of the study. Each of the 5 health facilities will identify 1350 children under 3 years of age in their respective catchment area. During the Surveillance stage, the participants will be enrolled into the study if and when they present with diarrhoea at the Health facility. Receives: Other: No intervention will be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MSD ETEC diarrhoea in Zambia.
Number of cases of moderate to severe diarrhoea (MSD) with confirmed ETEC aetiology in children under 3 years old in Zambia and the risk factors for ETEC diarrhoea
Measured: 12 months
Secondary outcomes (4)
Virulence factors of ETEC isolates
The prevalent ETEC virulence factors (LT, STh and STp ) and colonisation factors (CFA/I, CS1, CS2, CS3, CS4, CS5, CS6, CS7, CS8, CS12, CS14, CS17) in diarrhoeagenic isolates of ETEC.
Measured: 12 months
The common pathogens causing MSD in children less than 3 years
Number of diarrhoea cases due to Shigella, campylobacter coli/jejuni, Clostridium difficile, EAEC, EHEC, EPEC, Salmonella, Vibrio cholerae, Vibrio parahaemolyticus and Yersinia enterocolitica.
Measured: 12 months
Seasonality of ETEC diarrhoea
The incidence of ETEC positive diarrhoea cases per month for 1 year.
Measured: 12 months
Antimicrobial resistance pattern of ETEC
AMR pattern for ETEC will be determined by presence or absence of 9 major carbapenemases genes (KPC, NDM, VIM, IMP, OXA-23, OXA-24, OXA-48/181, OXA-51, OXA-58)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 Oct 2020
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea ToddlersStudies of the same condition, open and under way.
- 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
- 6,828 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Scandinavian Biopharma AB, Göteborg University
- Responsible party
- Sponsor
- Investigators
- Roma Chilengi, MBChB, Principal investigator, Centre for Infectious Disease Research in ZambiaMonde Muyoyeta, MBChB, Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838587
- Sponsor's protocol ID
- 1091-2020
- Acronym
- ETEC-Surv
- Status last verified
- Jul 2022
- First submitted
- 5 Feb 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka.
- ClinicalTrials.gov ID
- NCT04838587
- Acronym / sponsor ID
- ETEC-Surv / 1091-2020
- Conditions
- Diarrhea Toddlers, Escherichia Coli Diarrhea
- Keywords
- Incidence, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,828 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Scandinavian Biopharma AB, Göteborg University
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 9 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.
Diarrhoea is the one of the top five leading causes of death among children below the age of five years, globally. It is estimated that one in ten deaths in children under five is attributed to diarrhoea. Enterotoxigenic E.coli (ETEC) is one of the major causative agents of moderate-to-severe (MSD) diarrhoea among children both globally and in Zambia.
The overall aim of this study is to document the burden of ETEC associated diarrhoea in Zambian children under 3 years of age.
Detailed description
This study seeks to determine diarrhoea aetiology, calculate the incidence of moderate-to-severe ETEC-associated diarrhea, and describe the frequency of ETEC colonization factors and enterotoxin types in children under 3 years old in Zambia.
These data are required for the design of an anticipated phase 3 trial of the leading ETEC vaccine (ETVAX®) that will be evaluated in Zambia from 2021 onwards.
The following are the research questions that this study seeks to answer:
- What is the incidence of MSD with confirmed ETEC aetiology in children under three years old in Zambia?
- What are the prevalent colonization toxins and factors (CFs) in diarrhoeagenic isolates of ETEC infections in children in Zambia?
- What are the other common pathogens causing diarrhoea in Zambian children?
This prospective, observational, longitudinal study is proposed at five health facilities in Lusaka. The proposed study sites are Chawama, George, Kanyama, Chainda, and Matero Health Facilities. These facilities are located within typical peri-urban settlements of Lusaka and serves communities with a cumulative total population of over 1 million people. The study will be done in two stages beginning with a household census in the study catchment area of the participating health facilities and then followed by the passive diarrhoea surveillance stage. A surveillance system for passive case detection of diarrhoea will be set up at each facility for the 12-months of the project to detect any seasonal variations of disease burden. Prior to commencement, several community sensitization activities will be conducted within the catchment areas of the health facility.
A stool sample will be collected from each participant who presents to the health facility and is eligible for enrollment. All research samples will be collected at the study site and laboratory assays will be performed as per written SOPs and will be a part of the study documentation. All the samples will be processed in Zambia using the Novodiag® platform. The Novodiag® (Mobidiag Ltd, Finland) is a novel multiplex molecular platform that is based on real-time PCR and microarray technology and can identify various gastroenteritis causing bacteria, parasites and viruses as well as carry out antimicrobial resistance gene testing of organisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6750 Children <3 years ( 5 sites) | – | Other: No intervention will be doneA total of 6750 children from the will be identified from the respective health facility catchment area during the Census stage of the study. Each of the 5 health facilities will identify 1350 children under 3 years of age in their respective catchment area. During the Surveillance stage, the participants will be enrolled into the study if and when they present with diarrhoea at the Health facility. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study is a multi-site longitudinal observation study, to be conducted at Matero First Level Hospital, Chawama First Level Hospital, George Clinic, Kanyama First Level Hospital and Chainda clinic in Lusaka. The facilities are situated in a typical peri-urban settlement area of Lusaka and serves a community with a combined population of about 1 million. We assume that all sites have similar incidence of ETEC diarrhoea, therefore, each of the 5 sites will enroll 1350 children bringing our total sample size for the study to 6,750 participants.
Key inclusion criteria (6 listed)
- A child < 36 months old at the time of enrolment.
- A child presenting with diarrhoea (i.e. > 3 episodes of looser than normal stools in 24 hours) at a health facility within the study catchment area and in possession of a study ID number.
- Parents of eligible children, able to understand the study information and give informed consent by signature or thumbprint. (NB. illiterate participants will be able to give consent in the presence of an impartial witness)
- Children living within the study catchment area served by each participating health facility and in possession of a study ID number
- The parent/s who is willing to comply with all stipulated study procedures.
Key exclusion criteria (3 listed)
- Children presenting to the health facility without a study ID number
- Any child born after the Census has taken place
- Any child currently participating in the OEV124 study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be doneNo intervention,Only passive surveillance of Diarrhoea cases will be done | Other | 6750 Children <3 years ( 5 sites) |
Primary outcome
Incidence of MSD ETEC diarrhoea in Zambia.
Time frame: 12 months
Number of cases of moderate to severe diarrhoea (MSD) with confirmed ETEC aetiology in children under 3 years old in Zambia and the risk factors for ETEC diarrhoea
4 secondary outcomes
Virulence factors of ETEC isolates
Time frame: 12 months
The common pathogens causing MSD in children less than 3 years
Time frame: 12 months
Seasonality of ETEC diarrhoea
Time frame: 12 months
Antimicrobial resistance pattern of ETEC
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
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.
Roma Chilengi, MBChB principal investigator
Centre for Infectious Disease Research in Zambia
Monde Muyoyeta, MBChB principal investigator
Centre for Infectious Disease Research in Zambia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea Toddlers and Escherichia Coli Diarrhea, run by Centre for Infectious Disease Research in Zambia at 4 sites in Zambia.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Zambia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MSD ETEC diarrhoea in Zambia. (time frame: 12 months). 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 20 Jul 2022.