The purpose of this study is to evaluate whether antibiotic treatment of non-dysentery Shigella associated watery diarrhea (NDSD) cases improves clinical outcomes and growth in children.
Children with NDSD seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive Azithromycin or placebo (a look-alike substance that contains no drug). Enrolled children will be followed for three months with household visits.
The investigators will determine whether antibiotic treatment of NDSD reduces the duration of diarrhea and time to microbiological cure (shedding of Shigella in stool), and whether it improves growth in children compared with the placebo group.
Who can participate
Age range
6 Months – 59 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:
* Patients \>6 and ≤59 months of age seeking care in the study hospitals
* Patients residing within the study catchment area
* Present with watery diarrhea and positive for Shigella by RLDT
* Willing to be available for sample and data collection during the follow up visits
Exclusion Criteria:
* Inability or unwillingness of a participant's parent/guardian to give written informed consent or comply with study protocol
* Diarrhea started more than 96 hours before enrollment
* Antibiotics related to shigellosis treatment (including the investigational drug azithromycin) taken in the past 5 days
* More than 2 doses of antidiarrheal drugs taken in the past 24 hours
* History of allergy to Azithromycin
* Presence of visible blood in stool
* Children with severe acute malnutrition (below -3z scores of the median WHO growth standards).
* History of congenital heart diseases, known gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease, inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic/long-term steroid treatment or other immunosuppressive treatment
* Fever over 39°C (102°F) with other complications that require antibiotic treatment
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the st…
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
1
Time to cessation of diarrhea (TCD)
Timeframe: From the time of the administration of Azithromycin or placebo until cessation of the diarrhea episode (approximately up to a month)
2
Change in weight for age Z score (WAZ)
Timeframe: From enrollment to the 90-day follow up
Trial details
NCT IDNCT07433426
SponsorJohns Hopkins Bloomberg School of Public Health