Dose-finding of oxantel pamoate in school-aged children infected with Trichuris trichiura on Pemba, United Republic of Tanzania

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN86603231
• Date of registration: 12/11/2014
• Prospective Registration: No
• Primary sponsor: Swiss National Science Foundation (SNSF) (Switzerland)
• Public title: Dose-finding of oxantel pamoate in school-aged children infected with Trichuris trichiura on Pemba, United Republic of Tanzania
• Scientific title: Dose-finding of oxantel pamoate in school-aged children infected with Trichuris trichiura on Pemba, United Republic of Tanzania: a randomized controlled phase 2a trial
• Date of first enrolment: 16/10/2014
• Target sample size: 350
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN86603231
• Study type: Interventional
• Study design: Randomized controlled phase 2a dose finding trial (Treatment)
• Phase: Phase II

Countries of recruitment

Tanzania

Contacts

• Name: Jennifer Keiser

Key inclusion & exclusion criteria

Inclusion criteria: 1. Written informed consent signed by parents and/or legal guardian; and oral assent by children
2. Able and willing to be examined by a study physician at the beginning of the study
3. Able and willing to provide two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up)
4. Positive for T. trichiura eggs in the stool
5. Absence of major systemic illnesses (e.g. cancer, diabetes, clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment
6. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease
7. No recent anthelminthic treatment (within past 4 weeks)
8. No known allergy to study medications
Exclusion criteria: 1. No written informed consent by parents and/or legal guardian
2. Presence of any abnormal medical condition, judged by the study physician
3. History of acute or severe chronic disease such as cancer, diabetes, chronic heart, liver or renal disease
4. Recent use of anthelminthic drug (within past 4 weeks)
5. Attending other clinical trials during the study
6. Negative diagnostic result for T. trichiura (absence of helminth eggs in stool)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Trichuriasis
Infections and Infestations

Intervention(s)

Two stool samples will be collected on two consecutive days. The medical history of the participating schoolchildren will be assessed with a standardized and previously used questionnaire, in addition to a clinical examination carried out by the study physician on the treatment day. All children positive for T. trichiura will be randomly assigned (computer-generated stratified block randomization code) to one of the seven treatment arms: 5, 10, 15, 20, 25, 30 mg/kg oxantel pamoate and placebo. School-aged children will also be interviewed before treatment, 2 and 24 hours after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 21-26 days post-treatment by collecting another two stool samples. All stool samples will be examined with duplicated Kato-Katz thick smears.

1. 400 mg placebo
2. Oxantel pamoate 5 mg/kg
3. Oxantel pamoate 10 mg/kg
4. Oxantel pamoate 15 mg/kg
5. Oxantel pamoate 20 mg/kg
6. Oxantel pamoate 25 mg/kg
7. Oxantel pamoate 30 mg/kg

Primary Outcome(s)

1. Cure rate (CR) and egg reduction rate (ERR) against T. trichiura: 14-21 days post-treatment
2. Safety/adverse events: 3 hours and 24 hours post-treatment

Secondary Outcome(s)

CR and ERR against A. lumbricoides and hookworms

Source(s) of Monetary Support

Swiss National Science Foundation (Switzerland)