The Impact of Shigellosis and Recommended Treatment in Children
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-59
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Azithromycin
- Placebo
Treatment groups
700 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov