NCT07433426 The Impact of Shigellosis and Recommended Treatment in Children
| NCT ID | NCT07433426 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Diarrhea Infectious |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 700 participants in total. It began in 2026-03-18 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
Contact & Investigator
Subhra Chakraborty, PhD, MPH, MSc
PRINCIPAL INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Frequently Asked Questions
Who can join the NCT07433426 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 59 Months, studying Diarrhea Infectious. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07433426 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07433426 currently recruiting?
Yes, NCT07433426 is actively recruiting participants. Contact the research team at schakr11@jhu.edu for enrollment information.
Where is the NCT07433426 trial being conducted?
This trial is being conducted at Chāndpur, Bangladesh, Dhaka, Bangladesh, Lusaka, Zambia, Ndola, Zambia.
Who is sponsoring the NCT07433426 clinical trial?
NCT07433426 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Subhra Chakraborty, PhD, MPH, MSc at Johns Hopkins Bloomberg School of Public Health. The trial plans to enroll 700 participants.