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

NCT06720259 | Completed Phase 2

• 1 other identifier: OXA-TRI_1
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (3)

Oxantel Single Dose

EXPERIMENTAL

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

Drug: Oxantel Pamoate

Oxantel Multiple Dose

EXPERIMENTAL

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

Drug: Oxantel Pamoate

Mebendazole Single Dose

ACTIVE COMPARATOR

Mebendazole (500mg), orally administered on day 0

Drug: Mebendazole

Interventions

Oxantel Pamoate DRUG

Tablets containing 250 mg oxantel pamoate

Oxantel Multiple Dose; Oxantel Single Dose

Mebendazole DRUG

Tablets containing 500 mg mebendazole

Mebendazole Single Dose

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Keiser: lead
• Public Health Laboratory Ivo de Carneri: collaborator

Study Sites (1)

Public Health Laboratory Ivo de Carneri

Chake Chake, Tanzania

Location

MeSH Terms

Conditions

Trichuriasis; Hookworm Infections

Interventions

oxantel pamoate; Mebendazole

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Strongylida Infections; Secernentea Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jennifer Keiser, PhD

  Swiss Tropical & Public Health Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: April 16, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

TA (1)