Clinical Trials/NCT06720259

NCT06720259

Completed

Phase 2

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

Jennifer Keiser1 site in 1 country163 target enrollmentApril 16, 2025

ConditionsTrichuris Trichiura; Infection Hookworm Infection Ascaris Lumbricoides Infection

InterventionsOxantel Pamoate Mebendazole

DrugsOxantel Pamoate Mebendazole

Overview

Phase: Phase 2
Intervention: Oxantel Pamoate
Conditions: Trichuris Trichiura; Infection
Sponsor: Jennifer Keiser
Enrollment: 163
Locations: 1
Primary Endpoint: Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 16, 2025

End Date

May 28, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jennifer Keiser

Responsible Party

Sponsor Investigator

Principal Investigator

Jennifer Keiser

Prof. Dr.

Swiss Tropical & Public Health Institute

Eligibility Criteria

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

Arms & Interventions

Oxantel Single Dose

Treatment with oxantel pamoate (20 mg/kg), orally administered on day 0

Intervention: Oxantel Pamoate

Oxantel Multiple Dose

Treatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2

Intervention: Oxantel Pamoate

Mebendazole Single Dose

Mebendazole (500mg), orally administered on day 0

Intervention: Mebendazole

Outcomes

Primary Outcomes

Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura

Time Frame: 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 Outcomes

Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura(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(14-21 days after treatment)
Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura(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(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(3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment)