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CTRI Number  CTRI/2017/07/009017 [Registered on: 11/07/2017] Trial Registered Prospectively
Last Modified On: 16/09/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Improved Diarrhoea Management for Children with High Risk of Mortality 
Scientific Title of Study   Antibiotics for Children with Severe Diarrhoea (ABCD) Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Sazawal 
Designation  Executive Director 
Affiliation  Center For Public Health Kinetics 
Address  214A Basement, Vinoba Puri, Lajpat Nagar-II, New Delhi
none
New Delhi
DELHI
110024
India 
Phone  41724901  
Fax  41724904  
Email  ssazawal@jhu.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Sazawal 
Designation  Executive Director 
Affiliation  Center For Public Health Kinetics 
Address  214A Basement, Vinoba Puri, Lajpat Nagar-II, New Delhi
none
New Delhi
DELHI
110024
India 
Phone  41724901  
Fax  41724904  
Email  ssazawal@jhu.edu  
 
Details of Contact Person
Public Query  
Name  Dr P K Gupta 
Designation  Professor and Head 
Affiliation  Subharti Medical College 
Address  Department of Pediatrics, Subharti Medical College Hospital, Subhartipuram, NH-58, Meerut

Meerut
UTTAR PRADESH
2500025
India 
Phone  0121-2439112  
Fax    
Email  drgupta_jsr@rediffmail.com  
 
Source of Monetary or Material Support  
World Health Organization, Geneva 
 
Primary Sponsor  
Name  Center For Public Health Kinetics 
Address  214-A Basement, Vinoba Puri, Lajpat Nagar-II, New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Bangladesh
Kenya
Malawi
Mali
Pakistan
United Republic of Tanzania  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunil Sazawal  Health facilities of Meerut District  P L Sharma District Hospital, Near Ghanta Ghar, Ahmed Road, Meerut - 250002 LLRM Medical College, Garh Road, Meerut, UP-250002 Subharti Medical College & Hospital, Subhartipuram, NH-58, Meerut, UP. 2500025 Some of CHCs/PHCs of Meerut district
Meerut
UTTAR PRADESH 		 91-11-41724901
91-11-41724904
ssazawal@jhu.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Subharti Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Young children (2-23 mo) presenting with acute diarrhea and either malnutrition or dehydration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Azithromycin  3-day course of azithromycin will be given as 1 dose per day (10 mg/kg)in the morning  
Comparator Agent  Placebo for azithromycin   3-day course of placebo azithromycin will be given as 1 dose per day in the morning 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  23.00 Month(s)
Gender  Both 
Details  1.Children aged 2 – 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) <-3 SD) AND
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

 
 
ExclusionCriteria 
Details  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 −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.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
-Mortality
-Hospitalizations(number and categorized causes)
-Assessment of linear growth (∆length-for-age z-score):  		 From enrolment till Day-90 of follow-up (if the participant misses day-90 visit, mortality data can be collected until day-180
 
 
Secondary Outcome  
Outcome  TimePoints 
-Assessment of acute malnutrition (∆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)  		 -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) 
 
Target Sample Size   Total Sample Size="11500"
Sample Size from India="1650" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/07/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/08/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The study is a double-blind, placebo controlled, randomized trial aims to evaluate the efficacy of antibiotic (azithromycin), compared to placebo, in reducing risk of death and linear growth faltering in the three months following an episode of diarrhea among children (2-23 months of age) at high-risk of diarrhea-associated mortality. In this trial, 11,500 children aged 2 to 23 months presenting to health facilities/hospitals in 7 Asian (Bangladesh, India and Pakistan) and Sub-Saharan African countries with acute diarrhea and either malnutrition or dehydration will be enrolled and followed up for 90 days (a subgroup will be followed up for 180 days). Children will be randomized to receive a three-day course of azithromycin, or placebo. In India, the study will be conducted in two tertiary care hospitals [1 private - Subharti Medical College (SMC) and 1 government - Lala Lajpat Rai Memorial (LLRM) Medical College], and 1 district hospital of the Meerut District, Uttar Pradesh and in selected CHCs/PHCs.


Surveillance system will be set up at the selected health facilities to identify children with diarrhoea. Children aged 2-23 months with diarrhea will undergo the screening process. At the time of screening, information on diarrhea, dehydration, danger signs, vital status, child’s medical history, family background will be taken and detailed physical examination will be conducted. Anthropometric measurements (weight, length, mid-upper arm circumference- MUAC) will also be taken and recorded. If the child meets the eligibility criteria, informed written consent will be obtained and the child gets enrolled. Enrolled children will be randomized to receive one of the two treatment regimes for three days under direct supervision and observation (DOT). At baseline, information on socio-demographics and child’s vaccination history will be obtained. In addition stool samples will be collected.


Children will be re-assessed at 3-months to determine the vital status of the child and to obtain anthropometric measurements. If at any of the follow-up visits, a caregiver reports that a child has died, a verbal autopsy interview will be conducted.


A sub-set of children (n- ~230) will also be followed for 6-months for additional sample collection for antimicrobial resistance (AMR) sub-study. Stool samples and nasopharyngeal swabs will be collected from enrolled children and child contact (6 months to 59 months of age) of the enrolled child at 3 months and 6 months.


The primary outcome measures will be all-cause mortality and linear growth faltering at 3 months. The secondary outcomes will be cause-specific mortality, acute malnutrition (∆MUAC and WHZ), individual and community-level antimicrobial resistance in bacterial enteric and nasopharyngeal infections at 3 months and 6 months.

 
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