Plain English Summary

Background and study aims
Between 600 and 800 million people are infected with one or several of the common soil-transmitted helminths, which are Ascaris lumbricoides, Trichuris trichiura, and hookworms. The current strategy to control soil-transmitted helminths is to administer either albendazole or mebendazole to people at risk. However, these drugs are not effective or only partially effective against T. trichiura and hookworm. Therefore new safe drugs are needed. The aim of this study is to compare the effectiveness and safety of albendazole, mebendazole, oxantel pamoate and an albendazole-oxantel pamoate combination against infections with T. trichiura and hookworm.

Who can participate?
Children aged 6-14 infected with T. trichiura or hookworm, or both.

What does the study involve?
Two stool samples will be collected from school-aged children until 380 cases of T. trichiura and/or hookworm infections have been identified. Positive tested children will be randomly assigned to one of the following four treatment groups: group 1 will receive oxantel pamoate on the first day and albendazole and a placebo (dummy) tablet on the next day. Group 2 will receive oxantel pamoate on day 1 and two placebo tablets on day 2. Group 3 will receive a placebo tablet on day 1 and one tablet of albendazole plus a placebo tablet on the next day. Group 4 will be administered a placebo tablet on day 1 and one mebendazole tablet plus one placebo tablet on day 2. Adverse effects will be assessed at 3 and 24 hours after each treatment.

What are the possible benefits and risks of participating?
The three drugs which are being compared are well known and have few adverse effects. All enrolled children will benefit from a free treatment against soil-transmitted helminths.

Where is the study run from?
The study will be carried out in three schools on Pemba, Tanzania and will be conducted by the Public Health Laboratory Ivo de Carneri (Tanzania).

When is the study starting and how long is it expected to run for?
The study will take place from September to November 2012.

Who is funding the study?
The study will be funded by the Medicor Foundation (Liechtenstein).

Who is the main contact?
Jennifer Keiser, Swiss Tropical and Public Health Institute, Basel, Switzerland.

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

University of Basel
Socinstr. 57
Basel
4051
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy and safety of albendazole-oxantel combined and single oxantel albendazole, and mebendazole, in the treatment of Trichuris trichiura and hookworm infections in Pemba: a randomized, double blind trial

Acronym

OXAALB-STH

Study hypothesis

Oxantel-albendazole reaches higher cure rates against T. trichiura and hookworm infections than the standard treatments (mebendazole).

Ethics approval

1. Ethics Committee of Basel [Ethikkomission beider Basel (EKBB)], 20/01/2012, ref: 390/11
2. Ministry of Health and Social Welfare, 27/07/2012, ref: ZAMREC/0001/JAN/011

Study design

Double-blind randomized controlled trial with four treatment arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

T. trichiura or/and hookworm infections

Intervention

Group 1:
Day 1: 20 mg/kg oxantel pamoate; Day 2: 1 albendazole tablet plus 1 mebendazole matching placebo

Group 2:
Day 1: 20 mg/kg oxantel pamoate; Day 2: 1 albendazole matching placebo plus 1 mebendazole matching placebo

Group 3:
Day 1: 20 mg/kg oxantel pamoate placebo; Day 2: 1 albendazole tablet plus 1 mebendazole matching placebo

Group 4:
Day 1: 20 mg/kg oxantel pamoate placebo; Day 2: 1 mebendazole tablet plus 1 albendazole matching placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Oxantel, oxantel-albendazole

Primary outcome measures

Cure rates and egg reduction rates 3 weeks after treatment. For diagnosis two stool samples will be collected before and after treatment. From each stool sample duplicate Kato-Katz thick smears will be examined.

Secondary outcome measures

Adverse events will be assessed 3 and 24 hours after each day of treatment.

Overall trial start date

10/09/2012

Overall trial end date

26/10/2012

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 and at the end of the study (3 weeks post-treatment)
3. Able and willing to provide two stool samples at the beginning and at the end of the study
4. Positive for T. trichiura or hookworm, or both STH concurrently (presence of helminth eggs in 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 chronic illness such 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

650

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 and/or hookworm (absence of helminth eggs in stool)

Recruitment start date

10/09/2012

Recruitment end date

26/10/2012

Locations

Countries of recruitment

Tanzania

Trial participating centre

University of Basel
Basel
4051
Switzerland

Sponsor information

Organisation

Medicor Foundation (Liechtenstein)

Sponsor details

Landstrasse 11
Postfach 141
Triesen
9495
Liechtenstein

Sponsor type

Charity

Website

http://www.medicor.li/

Funders

Funder type

Charity

Funder name

Medicor Foundation (Liechtenstein)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24521107

Publication citations

  1. Results

    Speich B, Ame SM, Ali SM, Alles R, Huwyler J, Hattendorf J, Utzinger J, Albonico M, Keiser J, Oxantel pamoate-albendazole for Trichuris trichiura infection., N. Engl. J. Med., 2014, 370, 7, 610-620, doi: 10.1056/NEJMoa1301956.

Editorial Notes