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

Jennifer Keiser

Status and phase: Completed; Phase 2

Conditions: Hookworm Infection; Trichuris Trichiura; Infection; Ascaris Lumbricoides Infection

Treatments: Drug: Mebendazole; Drug: Oxantel Pamoate

Study type: Interventional

Funder types: Other

Identifiers

NCT06720259

OXA-TRI_1

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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163 participants in 3 patient groups

Oxantel Single Dose

Experimental group

Description:

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

Treatment:

Drug: Oxantel Pamoate

Oxantel Multiple Dose

Experimental group

Description:

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

Treatment:

Drug: Oxantel Pamoate

Mebendazole Single Dose

Active Comparator group

Description:

Mebendazole (500mg), orally administered on day 0

Treatment:

Drug: Mebendazole