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NCT Number: NCT06720259

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

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.

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Key information

Conditions

Trichuris Trichiura; Infection Adenophorea Infections Ascaris Lumbricoides Infection Enoplida Infections Helminthiasis Hookworm Infection Hookworm Infections Infections Nematode Infections Parasitic Diseases Secernentea Infections Strongylida Infections Trichuriasis

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Public Health Laboratory Ivo de Carneri

Chake Chake, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxantel Pamoate

Drug

Tablets containing 250 mg oxantel pamoate

Mebendazole

Drug

Tablets containing 500 mg mebendazole

Primary outcomes

  1. 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

  1. Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura

    Time frame: 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.

  2. Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura

    Time frame: 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.

  3. Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura

    Time frame: 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.

  4. Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants

    Time frame: 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.

  5. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jennifer Keiser

Other

Collaborators

  • Public Health Laboratory Ivo de Carneri

Registry information

Official study title

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

Acronym: OXA-TRI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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