Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86603231
Enrollment
350
Registered
2014-11-12
Start date
2014-10-16
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trichuriasis Infections and Infestations

Interventions

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

Sponsors

Swiss National Science Foundation (SNSF) (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
CR and ERR against A. lumbricoides and hookworms

Countries

Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026