A Phase 2 interventional study of Azithromycin and Placebo in Diarrhea Infectious, Shigella and Growth & Development, sponsored by Johns Hopkins Bloomberg School of Public Health. Recruiting at 4 sites in 2 countries. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2, Interventional, and Treatment
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.
The current World Health Organization (WHO) guidelines for the treatment of diarrhea recommend antibiotics when visible blood is present in the stool and in cases suspected of cholera. Currently, >50% of Shigella-associated diarrhea cases are non-dysentery or watery diarrhea in nature; thus, would not be treated with antibiotics according to guidelines. Absence of dysentery does not exclude Shigella as a cause of diarrhea and may not indicate a lower risk of death. For particularly vulnerable younger or malnourished children, identification and treatment of Shigella infection might be lifesaving. Consequently, a critical question remains to be answered. Should cases of non-dysentery Shigella associated watery diarrhea (NDSD) be treated with antibiotics? The goal of this study is to determine whether antibiotic treatment of NDSD cases improves clinical outcomes and growth in children.
This is a phase 2B, randomized, double-blind, placebo-controlled study. Children aged >6-59 months with NDSD who are seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive either Azithromycin or a placebo (a look-alike substance that contains no drug). All children will be rehydrated with either oral rehydration solution or intravenous fluids, depending on the degree of dehydration, and will receive zinc in accordance with standard of care. Enrolled children will be followed for three months through household visits to collect morbidity and anthropometry data.
Primary Outcomes
Secondary Outcomes
61 studies on the registry are indexed under Dysentery, Bacillary; 6 are open to participants now.
This study's planned enrollment of 700 is above the median of 76 across 54 interventional studies indexed under Dysentery, Bacillary.
Browse Dysentery, Bacillary studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Compared within Dysentery, Bacillary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dysentery. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Immunosuppression
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Corticosteroids (steroids)
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Children 6-59 months with non-dysentery shigella diarrhea will be treated with Azithromycin 10 mg/kg once daily for 5 days.
Drug: Azithromycin
Children 6-59 months with non-dysentery Shigella diarrhea will receive placebo similar in appearance to the experimental drug once daily for 5 days.
Drug: Placebo
Azithromycin will be given as 10 mg/kg body weight once daily for 5 days
Placebo will be similar in appearance to the intervention but will contain inactive ingredients.
Time to cessation of diarrhea (TCD)
Diarrhea will be defined as 3 or more liquid or loose stool during a 24 hours period (not calendar day). Two diarrhea episodes will be separated by three diarrhea free days in between. Time to cessation of diarrhea (TCD) will be expressed in hours.
Time frame: From the time of the administration of Azithromycin or placebo until cessation of the diarrhea episode (approximately up to a month)
Change in weight for age Z score (WAZ)
The change in weight for age Z scores from enrollment to the 90-day follow-up
Time frame: From enrollment to the 90-day follow up
Time to microbiological cure
The interval between the administration of the intervention or placebo and two consecutive Shigella-negative stools by culture or Rapid LAMP-based Diagnostic test (RLDT) - a validated point-of-care diagnostic test.
Time frame: Enrollment to microbiological cure (up to 3 months)
Change in length for age Z score (LAZ)
Percentage change and mean difference in LAZ from enrollment to 90-day follow-up between the two arms.
Time frame: From enrollment to 90-day follow-up.
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Studies of the drug tested here: Azithromycin
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