Triple drug study for lymphatic filariasis eliminatio
- Registration Number
- CTRI/2016/10/007399
- Lead Sponsor
- Vector Control Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9060
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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, efficacy and acceptability of three drugs versus two drugsTimepoint: Safety - Monitoring adverse events for 7 days post-drug administration <br/ ><br> <br/ ><br>Efficacy - At one year post-drug administration <br/ ><br> <br/ ><br>Acceptability - Assessment within 4 months of drug administration <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Effectiveness of the treatmentTimepoint: After 12 months post treatment