Trichuris Trichiura; Infection, Hookworm Infection, Ascaris Lumbricoides Infection
Conditions
Brief summary
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.
Interventions
DRUGOxantel Pamoate
Tablets containing 250 mg oxantel pamoate
DRUGMebendazole
Tablets containing 500 mg mebendazole
Sponsors
Public Health Laboratory Ivo de Carneri
Jennifer Keiser
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 2 and 12 years. * Written informed consent signed by parents/caregivers (signature or thumbprint) and, for children aged 6-12 years, written assent from the child. * Agree to comply with study procedures, including provision of two stool samples at the baseline and at follow-up assessment 14-21 days after treatment, respectively. * At least two out of four Kato-Katz thick smears positive for T. trichiura at baseline. * Willing to be examined by a study physician prior to treatment.
Exclusion criteria
* Presence or signs of major systemic illness or abnormal physical findings at screening, e.g. severe anaemia (Hb level \<80 g/L according to WHO) upon initial clinical assessment. * Known allergy to study medication (i.e. oxantel pamoate, mebendazole or any of the excipients). * Use of anthelminthic drugs within 4 weeks before or during study period. * Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication. * Actively participating in other clinical trials during the study. * Pregnancy (female participants that report to have reached menarche
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura | 14-21 days after treatment | CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura | 14-21 days after treatment | 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. |
| Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura | 14-21 days after treatment | CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively. |
| Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura | 14-21 days after treatment | CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively. |
| Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants | 14-21 days after treatment | CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively. |
| 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 | 3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment | 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. |
Countries
Tanzania
Outcome results
None listed