Health Condition 1: null- Young children (2-23 mo) presenting with acute diarrhea and either malnutrition or dehydration
Conditions
Interventions
Intervention1: Azithromycin: 3-day course of azithromycin will be given as 1 dose per day (10 mg/kg)in the morning
Intervention2: Ciprofloxacin: 3-day course of ciprofloxacin will be given as two dos
Sponsors
Center For Public Health Kinetics
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children aged 2 â?? 23 months, presenting to a designated health care facility at a participating study site WITH 2.Diarrhoea per caregiver perception AND at least 3 unusually loose or watery stools in the previous 24 hours, 3.Diarrhoea for less than 14 days prior to screening AND with at least one of the following criteria at presentation: 3.1.Signs of some or severe dehydration as per WHO pocket Book 2013 3.2.Moderately wasted as defined by a mid-upper arm circumference (MUAC) less than 125 mm (but greater than or equal to 115 mm) or a weight-for-length z score (WLZ) greater than -3SD and less than or equal to -2SD after rehydration during stabilization period or 3.3.Severely stunted (Length-for-age z-score (LAZ) 4.Parent or guardian (caregiver) willing to allow household visits on DAY 2 and DAY 3 and willing to return to facility on DAY 90 AND 5.Parent or guardian (caregiver) provides a consent for trial participation on behalf of the child
Exclusion criteria
Exclusion criteria: 1.Dysentery (gross blood in stool reported by parent or observed by HCW) 2.Suspected Vibrio Cholerae infection (determined according to WHO guidelines or clinical suspicion) 3.Previously or currently enrolled in the ABCD study 4.Concurrently enrolled in another interventional clinical trial 5.Sibling or other child in the household enrolled in the ABCD study and currently taking study medication 6.Signs of associated infections (pneumonia, severe febrile illness, meningitis, mastoiditis or acute ear infection)requiring alternate antibiotic treatment 7.Documented antibiotic use in the 14 days prior to screening (not including standard use of prophylactic antibiotics, i.e. co-trimoxazole use in HIV-exposed children) 8.Documented use of metronidazole within the last 14 days 9.Known allergy or contraindication to azithromycin antibiotics 10.Severe acute malnutrition(SAM)defined as weight-for-length z-score less than â??3 SD, or MUAC less than 115 mm or edema of both feet,OR 11.Living too far from the enrolment health center to ensure adequate Directly Observed Therapy(DOT)on DAY 2 and DAY 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Mortality -Hospitalizations(number and categorized causes) -Assessment of linear growth (â??length-for-age z-score):Timepoint: From enrolment till Day-90 of follow-up (if the participant misses day-90 visit, mortality data can be collected until day-180 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Assessment of acute malnutrition (â??MUAC and WHZ) -Assessment of cause specific mortality (determined by verbal autopsy) -Assessment of Antimicrobial resistance [Prevalence of resistance among enrolled children to selected antibiotics in E. coli (stool sample)and S. pneumoniae isolates (naso-pharyngeal swabs)] -Prevalence of resistance among close contacts of enrolled children to selected antibiotics in E. coli (stool sample)and S. pneumoniae isolates (naso-pharyngeal swabs)Timepoint: -enrolment and at the DAY 90 visit (DAY 80 to DAY 100) - Any time from enrolment to day-90 (if the participant misses day-90 visit, mortality data can be collected until day-180) -at enrolment (on all children), at DAY 90 (3 mo) and at DAY 180 (6 mo) (on a sub-sample) -at DAY 90 (3 mo) and at DAY 180 (6 mo) (on a sub-sample) | — |
Countries
Bangladesh, India, Kenya, Malawi, Mali, Pakistan, United Republic of Tanzania
Contacts
Public ContactDr P K Gupta
Center For Public Health Kinetics
Outcome results
None listed