Triple drug study for lymphatic filariasis elimination

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 - IDeAINDIA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/10/007399

Enrollment

12000

Registered

2016-10-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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) Control Intervention1: DA (Diethylcarbamazine and Albendazole): Co-administration of two drugs: DA (Diethylcarbamazine - 6mg/kg body weight

Albendazole -flat dose of 400 mg)

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: (i) Age (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

Design outcomes

Primary

Measure	Time frame
Safety, efficacy and acceptability of three drugs versus two drugsTimepoint: 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

Measure	Time frame
Effectiveness of the treatmentTimepoint: After 12 months post treatment	—

Countries

India

Contacts

Public ContactDr Vijesh Sreedhar Kuttiatt

Vector Control Research Centre

vijeshvcrc.icmr@gmail.com09497558764

Outcome results