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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Azithromycin
DrugAzithromycin will be given as 10 mg/kg body weight once daily for 5 days
Placebo
DrugPlacebo will be similar in appearance to the intervention but will contain inactive ingredients.
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: AzithromycinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the time of the administration of Azithromycin or placebo until cessation of the diarrhea episode (approximately up to a month)2
Change in weight for age Z score (WAZ)
The change in weight for age Z scores from enrollment to the 90-day follow-up
Time frame
From enrollment to the 90-day follow upSecondary outcomes
1
Time to microbiological cure
The interval between the administration of the intervention or placebo and two consecutive Shigella-negative stools by culture or Rapid LAMP-based Diagnostic test (RLDT) - a validated point-of-care diagnostic test.
Time frame
Enrollment to microbiological cure (up to 3 months)2
Change in length for age Z score (LAZ)
Percentage change and mean difference in LAZ from enrollment to 90-day follow-up between the two arms.
Time frame
From enrollment to 90-day follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov