Wuchereria Bancrofti Infection Clinical Trial
Official title:
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Single Dose Treatment With Diethylcarbamazine, Albendazole and Ivermectin in Humans With and Without Wuchereria Bancrofti Infection in Côte d'Ivoire
The study will be an open label cohort study with 2 two-treatment groups 2). Both groups will
be treated with a single oral administration of Diethylcarbamazine (DEC) 6 mg/kg +
Albendazole (ALB) 400 mg + Ivermectin (IVR) 200 µg/kg (IDA). One treatment group will include
men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will
include men and women who are free of W. bancrofti infection based on negative blood tests
for both microfilariae (Mf) and circulating filarial antigen (N=30). Active follow-up for
adverse events (AE) will be for 72hrs and passive follow-up for 7 days following treatment.
Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals
with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital
and cared for by the hospital staff. Based on treatment of over 100 Lymphatic filariasis (LF)
infected individuals any AEs develop within the first 72 hours following treatment and
uncommonly up to 7 days post-treatment.
All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.
Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling
for drug analyses and safety tests. Participants will undergo clinical monitoring every 6
hours to evaluate potential adverse effects of Ivermectin + Diethylcarbamazine + Albendazole
(IDA) treatment. Participants will also be monitored for hematologic, or biochemical
abnormalities during the period of observation.
The study will be an open label cohort study with 2 two-treatment groups. Both groups will be
treated with a single oral administration of DEC 6 mg/kg + ALB 400 mg + IVR 200 µg/kg (IDA).
One treatment group will include men and women with W. bancrofti infections (>50 Mf/ml,
N=30). The other treatment group will include men and women who are free of W. bancrofti
infection based on negative blood tests for both microfilariae and circulating filarial
antigen (N=30). Active follow-up for adverse events (AE) will be for 72 hours and passive
follow-up for 7 days following treatment.
Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals
with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital
and cared for by the hospital staff. Based on treatment of over 100 LF infected individuals
any AEs develop within the first 72 hours following treatment and uncommonly up to 7 days
post-treatment.
All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.
Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling
for drug analyses and safety tests. Participants will undergo clinical monitoring every 6
hours to evaluate potential adverse effects of IDA treatment. Participants will also be
monitored for hematologic, or biochemical abnormalities during the period of observation.
At enrollment all subjects will be otherwise healthy adult men and women (≥18-65 years of
age). All individuals will be assessed for the presence and burden of geohelminth infections,
parasitic worms of the gastrointestinal tract such as hookworm, Trichuris trichiuria and
Ascaris lumbricoides. This is important because two of the drugs in the combination (ALB and
IVM) are active against geohelminths. Individuals with heavy geohelminth burdens may
experience adverse reactions because of rapid killing of their intestinal parasites.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00375583 -
Effect of Albendazole Dose on Clearance of Filarial Worms
|
Phase 2 |