A community based study to compare the safety, efficacy and acceptabilityof a triple drug regimen (Ivermectin, Diethylcarbamazine and Albendazole)with a two-drug regimen (Diethylcarbamazine and Albendazole) forlymphatic filariasis elimination programme - IDeAINDIA

Vector Control Research Centre0 个研究点目标入组 9,060 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

发起方

Vector Control Research Centre