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CTRI Number  CTRI/2016/10/007399 [Registered on: 24/10/2016] Trial Registered Retrospectively
Last Modified On: 03/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Cluster Randomized Trial 
Public Title of Study   Triple drug study for lymphatic filariasis elimination 
Scientific Title of Study   A community based study to compare the safety, efficacy and acceptability of a triple drug regimen (Ivermectin, Diethylcarbamazine and Albendazole) with a two-drug regimen (Diethylcarbamazine and Albendazole) for lymphatic filariasis elimination programme 
Trial Acronym  IDeAINDIA 
Secondary IDs if Any  
Secondary ID  Identifier 
EM1605 14th (final) version dated 31 May 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Jambulingam 
Designation  Scientist G and Director 
Affiliation  Vector Control Research Centre (Indian Council of Medical Research) 
Address  Vector Control Research Centre (Indian Council of Medical Research) Indira Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  0413-2272422  
Fax  0413-2272041  
Email  pcsaja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijesh Sreedhar Kuttiatt 
Designation  Scientist E 
Affiliation  Vector Control Research Centre 
Address  Vector Control Research Centre (Indian Council of Medical Research) Indira Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  09497558764  
Fax  0413-2272041  
Email  vijeshvcrc.icmr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijesh Sreedhar Kuttiatt 
Designation  Scientist E 
Affiliation  Vector Control Research Centre 
Address  Vector Control Research Centre (Indian Council of Medical Research) Indira Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  09497558764  
Fax  0413-2272041  
Email  vijeshvcrc.icmr@gmail.com  
 
Source of Monetary or Material Support  
Task Force for Global Health 325 Swanton Way, Decatur GA 30030, USA 
 
Primary Sponsor  
Name  Vector Control Research Centre 
Address  Indira Nagar Pondicherry 605006 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr P Jambulingam  Yadgir, Karnataka  Yadgir, Karnataka
Gulbarga
KARNATAKA 
0413-2272422
0413-2272041
pcsaja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee of Vector Control Research Centre Reg No ECR/681/Inst/Py/2014  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All eligible individuals satisfying the inclusion criteria irrespective of their filarial infection status will be considered for participation in the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DA (Diethylcarbamazine and Albendazole)  Co-administration of two drugs: DA (Diethylcarbamazine - 6mg/kg body weight; Albendazole -flat dose of 400 mg) 
Intervention  IDA (Ivermectin, Diethylcarbamazine and Albendazole)  Co-administration of three drugs: IDA (Ivermectin - 200 micro gram/kg body weight; Diethylcarbamazine - 6mg/kg body weight; Albendazole- flat dose of 400 mg) 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Triple Drug Arm (IDA): participants more than or equal to 5 years of age and above 15 Kg body weight

Dual Drug Arm (DA): participants more than or equal to 2 years of age

Able to provide informed consent or give parental consent to minors to participate in the study

No evidence of severe or systemic co-morbidities except for features of filarial disease 
 
ExclusionCriteria 
Details  (i) Age <5 years(Ivermectin is not approved for use in children less than 5 years of age) and age 5 years and above with body weight below 15 Kg for IDA arm and age <2 years for DA arm

(ii) Pregnant women and women of child bearing age who cannot recall the timing of their last menstrual period or who report that their last menstrual period started 4 weeks or longer before the enrollment(Diethylcarbamazine, ivermectin and albendazole are not known to be safe for use during pregnancy.

(iii) Severe chronic illness(chronic renal insufficiency, severe chronic liver disease or any illness that is severe enough to interfere with activities of daily living)

(iv) History of previous allergy to MDA(Mass Drug Administration) drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety, efficacy and acceptability of three drugs versus two drugs  Safety - Monitoring adverse events for 7 days post-drug administration

Efficacy - At one year post-drug administration

Acceptability - Assessment within 4 months of drug administration

 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness of the treatment  After 12 months post treatment 
 
Target Sample Size   Total Sample Size="12000"
Sample Size from India="12000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="9060" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   07/10/2016 
Date of Study Completion (India) 03/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1. Weil GJ, Bogus J, Christian M, Dubray C, Djuardi Y, Fischer PU, Goss CW, Hardy M, Jambulingam P, King CL, Kuttiat VS, Krishnamoorthy K, Laman M, Lemoine JF, OBrian KK, RobinsonL, Samuela L,Schechtman KB, Sircar A, Srividya A, Steer AC, Supali T, S Subramanian. The safety of double- and triple-drug community mass drug administration for lymphatic filariasis: A multicenter, open-label, cluster-randomized study. PLoS Med 2019 16(6): e1002839. 2. Kuttiatt V, Somani R, Swaminathan S, Krishnamoorthy K, Weil G, Purushothaman J. The frequency and clinical significance of localized adverse events following mass drug administration for lymphatic filariasis in an endemic area in South India. Am J Trop Med Hyg (in press) 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

 Background: Drug regimens with better efficacy than that of the current regimen (diethylcarbamazine and albendazole - DA) used in mass drug administration(MDA) for lymphatic filariasis (LF) can accelerate the progress to elimination. This study was evaluated the safety, efficacy, effectiveness and community acceptability of a newer triple drug regimen(ivermectin, diethylcarbamazine and albendazole-IDA) for LF elimination.

Methods: This two arm open label community study was conducted in selected LF endemic villages of Yadgir, Karnataka as part of the multi-country study (India, Indonesia, Haiti, Papua New Guinea and Fiji). Study villages were block randomized to either arm. Participants were tested for filarial antigenemia and microfilaraemia and subsequently MDA was conducted. Participants were followed up for adverse events (AEs). Acceptability of MDA was assessed by a community survey( proforma, focus group discussions, in-depth interviews). Infected individuals were re-tested after an year for efficacy assessment. A community prevalence survey was done for assessment of effectiveness.

Results: 4758 participants received IDA; 4160, DA. Baseline antigenemia and microfilaraemia rate was 26.4% and 6.8% in IDA arm and 24.2% and 6.2%  in DA arm. AEs  rates were 8% in  IDA arm and 6.2% in DA arm(P<0.05). All the AEs resolved with symptomatic treatment. There were no serious AEs. AEs were significantly more common in persons with filarial infection. Complete clearance of Mf was observed in 84%  and 62% of MF positives in IDA arm and DA arm respectively(P<0.05). Community Mf prevalence reduced from 6.8% to 3.5% in IDA arm and 6.2 to 5.4% in DA arm(P<0.05).  Mean acceptability score of treatment was 27 and 26 in IDA and DA arms respectively, well above the acceptable critical level of 18.

Detailed data analysis is in progress for efficacy, effectiveness and acceptability aspects.  
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