CompletedNot Applicable

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

Zambia6,828 participantsStarted 2020-10-15

Plain-language 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.

Who can participate

Age range

36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of MSD ETEC diarrhoea in Zambia.

Timeframe: 12 months

Trial details

NCT IDNCT04838587

SponsorCentre for Infectious Disease Research in Zambia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-10-15

View on ClinicalTrials.gov More Diarrhea Toddlers trials