Condition category
Infections and Infestations
Date applied
08/10/2014
Date assigned
12/11/2014
Last edited
22/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Trichuris trichiura (whipworm) is a helminthic parasite, transmitted through soil. Whipworm infection is a neglected tropical disease and causes a huge burden worldwide. The available drugs have limitations. This study will compare the effectiveness of six different doses of a drug, oxantel pamoate, compared to a placebo (dummy) drug in school-aged children infected with T. trichiura, in order to find out the right dose of the drug.

Who can participate?
Children studying in the participating primary schools.

What does the study involve?
To examine whether children are infected, two stool samples will be collected and analysed. All children who are positive for T. trichiura will be randomly allocated to the seven different treatment groups and receive either one of six different doses of the drug or the placebo treatment. Children are interviewed to find out if they had any side effects. After three weeks, children will provide another two stool samples to see whether they got cured and to calculate egg reduction rates.

What are the possible benefits and risks of participating?
At the end of the study, children remaining positive for the infection will be treated according to national guidelines. All the working procedures and examinations during this study do not bear any particular additional risks. Side effects are mild and include stomach ache and dizziness.

Where is the study run from?
Two primary schools on Pemba Island, United Republic of Tanzania.

When is the study starting and how long is it expected to run for?
October 2014 to December 2014.

Who is funding the study?
Swiss National Science Foundation (Switzerland).

Who is the main contact?
Prof Jennifer Keiser
jennifer.keiser@unibas.ch

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

Swiss Tropical and Public Health Institute
Socinstr. 57
Basel
4051
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

No

Study information

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

Acronym

Oxpatri

Study hypothesis

Different doses of oxantel pamoate have not yet been sufficiently studied in infected school-aged children. Dosing regimens in humans are empirical.

Ethics approval

EKNZ 2014-315 (Switzerland), ZAMREC/0002/August/2014 (Zanzibar, Tanzania)

Study design

Randomized controlled phase 2a dose finding trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Trichuriasis

Intervention

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

Intervention type

Drug

Phase

Phase II

Drug names

Oxantel pamoate

Primary outcome measures

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 measures

CR and ERR against A. lumbricoides and hookworms

Overall trial start date

16/10/2014

Overall trial end date

29/11/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

350

Participant 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)

Recruitment start date

16/10/2014

Recruitment end date

29/11/2014

Locations

Countries of recruitment

Tanzania

Trial participating centre

Swiss Tropical and Public Health Institute
Basel
4051
Switzerland

Sponsor information

Organisation

Swiss National Science Foundation (SNSF) (Switzerland)

Sponsor details

Wildhainweg 3
Bern
3001
Switzerland

Sponsor type

Research organisation

Website

http://www.snf.ch

Funders

Funder type

Research organisation

Funder name

Swiss National Science Foundation (Switzerland)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26388169

Publication citations

Additional files

Editorial Notes