This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
163
Tablets containing 250 mg oxantel pamoate
Tablets containing 500 mg mebendazole
Public Health Laboratory Ivo de Carneri
Chake Chake, Tanzania
Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 14-21 days after treatment
Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 14-21 days after treatment
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Time frame: 14-21 days after treatment
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Time frame: 14-21 days after treatment
Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants
CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively.
Time frame: 14-21 days after treatment
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Number of adverse events (AE) to assess safety and tolerability of oxantel pamoate administered as a single dose or as multiple doses, and compared with mebendazole
Participants will be monitored at the site for 3 hours following treatment for any acute AEs. Participants will be interviewed 3 hours after treatment, as well as 24 hours after every dose received, as well as 14-21days after the last treatment dose about the occurrence of AEs. AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment.
Time frame: 3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment