Shigellosis Clinical Trials

Find Shigellosis Clinical Trials Near You

The Impact of Shigellosis and Recommended Treatment in Children

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Bangladesh
icddr,b Matlab Hospital
NOT_YET_RECRUITING
Chāndpur
icddr,b Hospital
RECRUITING
Dhaka
Zambia
Matero Level 1 Hospital
NOT_YET_RECRUITING
Lusaka
Arthur Davidson Children's Hospital
NOT_YET_RECRUITING
Ndola
Contact Information
Primary
Subhra Chakraborty, PhD, MPH, MSc
schakr11@jhu.edu
410-502-3154
Backup
Melissa Higdon, MPH
mhigdon@jhu.edu
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2030-08
Participants
Target number of participants: 700
Treatments
Experimental: Azithromycin
Children 6-59 months with non-dysentery shigella diarrhea will be treated with Azithromycin 10 mg/kg once daily for 5 days.
Placebo_comparator: Placebo
Children 6-59 months with non-dysentery Shigella diarrhea will receive placebo similar in appearance to the experimental drug once daily for 5 days.
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: Johns Hopkins Bloomberg School of Public Health

This content was sourced from clinicaltrials.gov