Last reviewed · How we verify
NCT07433426: TrtNDSD
The Impact of Shigellosis and Recommended Treatment in Children
Phase 2 trial testing Azithromycin in Diarrhea Infectious in 700 participants. Currently enrolling.
1 August 2029
Quick facts
| Lead sponsor | Johns Hopkins Bloomberg School of Public Health |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 700 |
| Start date | 18 March 2026 |
| Primary completion | 1 August 2029 |
| Estimated completion | 1 August 2030 |
| Sites | 4 locations across Bangladesh, Zambia |
Drugs / interventions tested
- Azithromycin (azithromycin) — full drug profile →
- Placebo
Conditions studied
- Diarrhea Infectious — all drugs for Diarrhea Infectious →
- Shigella — all drugs for Shigella →
- Growth & Development — all drugs for Growth & Development →
Sponsor
Johns Hopkins Bloomberg School of Public Health
Who can join
Adults 6 Months to 59 Months, any sex, with Diarrhea Infectious or Shigella. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time to cessation of diarrhea (TCD)
Time frame: From the time of the administration of Azithromycin or placebo until cessation of the diarrhea episode (approximately up to a month)
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. -
Change in weight for age Z score (WAZ)
Time frame: From enrollment to the 90-day follow up
The change in weight for age Z scores from enrollment to the 90-day follow-up
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07433426
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Azithromycin
Trials testing the same drug.
- NCT07306234 — Doxycycline vs. Macrolide for MRMP (DOMINO) · Phase 4 · not yet recruiting
- NCT06461429 — PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol] · NA · not yet recruiting
- NCT07164131 — Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lacta · Phase 4 · recruiting
- NCT07052942 — Individualizing Treatment for Asthma in Primary Care (Full Study) · Phase 4 · recruiting
- NCT07213765 — Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease · Phase 4 · recruiting
Other recruiting trials for Diarrhea Infectious
Currently open trials in the same condition.
- NCT07195006 — Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories · recruiting
- NCT06498817 — Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7) · NA · recruiting
- NCT05166850 — Preventative Intervention for Cholera for 7 Days · NA · recruiting
Other Johns Hopkins Bloomberg School of Public Health trials
Trials by the same sponsor.
- NCT07458230 — Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation: · Phase 3 · not yet recruiting
- NCT07227558 — Improving Information Sharing Between Family Caregivers and Home Care Aides · NA · recruiting
- NCT07536126 — Testing Non-Nutrition Menu Labels on Food Selections · NA · not yet recruiting
- NCT06426004 — Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland · NA · not yet recruiting
- NCT07344142 — Improving Digital Wellbeing in Saudi Adolescents · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07433426 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health
- Last refreshed: 27 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07433426.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing