The Impact of Shigellosis and Recommended Treatment in Children

NCT07433426 | Recruiting Phase 2 DMC

• 2 other identifiers: IRB00033101U01AI179562
• Study Type: interventional
• Target: 700
• Locations: 2 countries
• Sites: 4

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.

Conditions

Diarrhea Infectious; Shigella; Growth & Development

Keywords

shigella; children; randomized clinical trial; weight for age; growth outcomes; Azithromycin; Diarrhea

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  From enrollment to the 90-day follow up

Secondary Outcomes (2)

• Time to microbiological cure

  Enrollment to microbiological cure (up to 3 months)

• Change in length for age Z score (LAZ)

  From enrollment to 90-day follow-up.

Study Arms (2)

Azithromycin

EXPERIMENTAL

Children 6-59 months with non-dysentery shigella diarrhea will be treated with Azithromycin 10 mg/kg once daily for 5 days.

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

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

Interventions

Azithromycin DRUG

Azithromycin will be given as 10 mg/kg body weight once daily for 5 days

Azithromycin

Placebo DRUG

Placebo will be similar in appearance to the intervention but will contain inactive ingredients.

Placebo

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (4)

icddr,b Matlab Hospital

Chāndpur, Bangladesh

NOT YET RECRUITING

icddr,b Hospital

Dhaka, Bangladesh

RECRUITING

Matero Level 1 Hospital

Lusaka, Zambia

NOT YET RECRUITING

Arthur Davidson Children's Hospital

Ndola, Zambia

NOT YET RECRUITING

Related Publications (4)

• Dash S, Sultana E, Flynn K, Naz F, Ali M, Rahman MR, Rohman MM, Das S, Ahmed T, Faruque A, Chakraborty S. Evaluation of the performance and feasibility of RLDT in detecting Shigella in a primary healthcare facility of rural Bangladesh. medRxiv [Preprint]. 2025 Dec 11:2025.12.08.25341873. doi: 10.64898/2025.12.08.25341873.

  PMID: 41415506 BACKGROUND

• Connor S, Velagic M, Zhang X, Johura FT, Chowdhury G, Mukhopadhyay AK, Dutta S, Alam M, Sack DA, Wierzba TF, Chakraborty S. Evaluation of a simple, rapid and field-adapted diagnostic assay for enterotoxigenic E. coli and Shigella. PLoS Negl Trop Dis. 2022 Feb 7;16(2):e0010192. doi: 10.1371/journal.pntd.0010192. eCollection 2022 Feb.

  PMID: 35130310 BACKGROUND

• Chowdhury G, Ghosh D, Zhou Y, Deb AK, Mukhopadhyay AK, Dutta S, Chakraborty S. Field evaluation of a simple and rapid diagnostic test, RLDT to detect Shigella and enterotoxigenic E. coli in Indian children. Sci Rep. 2024 Apr 16;14(1):8816. doi: 10.1038/s41598-024-59181-6.

  PMID: 38627472 BACKGROUND

• Chakraborty S, Connor S, Velagic M. Development of a simple, rapid, and sensitive diagnostic assay for enterotoxigenic E. coli and Shigella spp applicable to endemic countries. PLoS Negl Trop Dis. 2022 Jan 28;16(1):e0010180. doi: 10.1371/journal.pntd.0010180. eCollection 2022 Jan.

  PMID: 35089927 BACKGROUND

MeSH Terms

Conditions

Dysentery; Dysentery, Bacillary; Diarrhea

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Subhra Chakraborty, PhD, MPH, MSc

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subhra Chakraborty, PhD, MPH, MSc

CONTACT

410-502-3154; schakr11@jhu.edu

Melissa Higdon, MPH

CONTACT

mhigdon@jhu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participating parties with the exception of the study statistician will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 25, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

BA (2); ZA (2)