An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka

NCT04838587 | Completed

• 1 other identifier: 1091-2020
• Study Type: observational
• Target: 6,828
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Diarrhea Toddlers; Escherichia Coli Diarrhea

Keywords

Incidence; Epidemiology

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (4)

• Virulence factors of ETEC isolates

  12 months

• The common pathogens causing MSD in children less than 3 years

  12 months

• Seasonality of ETEC diarrhoea

  12 months

• Antimicrobial resistance pattern of ETEC

  12 months

Study Arms (1)

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.

Other: No intervention will be done

Interventions

No intervention will be done OTHER

No intervention,Only passive surveillance of Diarrhoea cases will be done

6750 Children <3 years ( 5 sites)

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Scandinavian Biopharma AB: collaborator
• Göteborg University: collaborator

Study Sites (4)

Chawama First level hospital

Lusaka, 10101, Zambia

Location

George Clinic

Lusaka, 10101, Zambia

Location

Kanyama First Level Hospital

Lusaka, 10101, Zambia

Location

Matero Clinical Research Site, Chainda South CRS

Lusaka, 10101, Zambia

Location

Biospecimen

Retention: SAMPLES WITH DNA

faecal specimen

Study Officials

• Roma Chilengi, MBChB

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

• Monde Muyoyeta, MBChB

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: April 9, 2021
• Study Start: October 15, 2020
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

ZA (4)