Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura

Phase 2

Active, not recruiting

• Conditions: Trichuris Trichiura; Infection; Ascaris Lumbricoides Infection; Hookworm Infection
• Interventions: Drug: Oxantel Pamoate; Drug: Mebendazole

• Registration Number: NCT06720259
• Lead Sponsor: Jennifer Keiser

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-06
• Study Start: 2025-04-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxantel Single Dose	Oxantel Pamoate	Treatment with oxantel pamoate (20 mg/kg), orally administered on day 0
Oxantel Multiple Dose	Oxantel Pamoate	Treatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2
Mebendazole Single Dose	Mebendazole	Mebendazole (500mg), orally administered on day 0

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Public Health Laboratory Ivo de Carneri; 🇹🇿 Chake Chake, Tanzania