Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura (OXA-TRI)

A Randomised, Single-Blinded Phase II Trial to Assess the Efficacy, Safety and Acceptability of Oxantel Pamoate in Comparison to Mebendazole for Trichuris Trichiura Infections in Children Aged 2-12 Years

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 Overview

• Status: Completed
• Conditions: Hookworm Infection; Ascaris Lumbricoides Infection; Trichuris Trichiura; Infection
• Intervention / Treatment: Drug: Oxantel Pamoate; Drug: Mebendazole

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 2

Contacts and Locations

Study Locations

• Tanzania
  • Chake Chake, Tanzania
    • Public Health Laboratory Ivo de Carneri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxantel Single Dose; Treatment with oxantel pamoate (20 mg/kg), orally administered on day 0	Drug: Oxantel Pamoate; Tablets containing 250 mg oxantel pamoate
Experimental: Oxantel Multiple Dose; Treatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2	Drug: Oxantel Pamoate; Tablets containing 250 mg oxantel pamoate
Active Comparator: Mebendazole Single Dose; Mebendazole (500mg), orally administered on day 0	Drug: Mebendazole; Tablets containing 500 mg mebendazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14-21 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	14-21 days after treatment
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.	3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment

Collaborators and Investigators

• Sponsor: Jennifer Keiser
• Collaborators: Public Health Laboratory Ivo de Carneri
• Investigators: Study Chair: Jennifer Keiser, PhD, Swiss Tropical & Public Health Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Parasitic Diseases; Secernentea Infections; Nematode Infections; Helminthiasis; Enoplida Infections; Adenophorea Infections; Strongylida Infections; Infections; Communicable Diseases; Trichuriasis; Hookworm Infections; Ancylostomiasis; Anti-Infective Agents; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Piperazine; Mebendazole; Piperazine citrate; DMP 777; Oxantel; Oxantel pamoate
• Other Study ID Numbers: OXA-TRI_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No