Clinical trial NCT06720259: Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichuris Trichiura; Infection
Hookworm Infection
Ascaris Lumbricoides Infection
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Public Health Laboratory Ivo de Carneri
First posted: 2024-12-06
Enrollment: 163
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura
timeFrame: 14-21 days after treatment
Secondary outcomes:
measure: Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura
timeFrame: 14-21 days after treatment
measure: Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura
timeFrame: 14-21 days after treatment
measure: Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura
timeFrame: 14-21 days after treatment
measure: Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants
timeFrame: 14-21 days after treatment
measure: 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
timeFrame: 3 hours, 24 hours (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment
Other outcomes:
Locations:
city: Chake Chake
country: Tanzania
facility: Public Health Laboratory Ivo de Carneri
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Jennifer Keiser, PhD
role: STUDY_CHAIR
References: