Condition category
Infections and Infestations
Date applied
16/07/2013
Date assigned
01/08/2013
Last edited
08/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parasitic worm infections are widespread and they affect the health and wellbeing of mainly rural communities in the developing world. More than one billion people are infected with one or several of the common soil-transmitted helminths (STH). Treatment of STH infection with a single oral dose of current drugs is unsatisfactory. Several drug combinations have shown to be more effective than the currently recommended standard drug mebendazole. In this study we would like to assess various drug combinations and find out which combination should be recommended for the treatment of STH infection. In addition, we would like to monitor the effect of the three drug combinations on other parasitic infections and to find out the clinical benefit of the tested drug combinations based on history of self-reported signs and symptoms, physical examination and blood tests.

Who can participate?
Children aged 6 to 14 years can participate in this study.

What does the study involve?
Children will be given a written consent form and two containers. If willing to participate they shall return the consent form signed by their parents and the two containers filled with a fresh morning stool sample each. Stool samples will be tested for STH eggs. Children diagnosed positive for infection will be randomly allocated to one of the four treatment groups. Before receiving treatment, children will be checked by a physician. A finger prick blood sample will be taken from children before treatment. Children will be interviewed 2 hours and 24 hours after treatment about the occurrence of side effects. The effectiveness of the treatment will be determined 19-25 days after treatment, testing stool samples for STH eggs. About three months after treatment, when the clinical benefits are more likely to be measurable, children will again undergo a rigorous clinical examination. A finger prick blood sample will again be tested for hemoglobin levels and a questionnaire focusing on signs and symptoms will be given. To check if children were re-infected they will be asked to provide more stool samples which will be examined for STH eggs.

What are the possible benefits and risks of participating?
All children participating will benefit from a free treatment of a potentially active drug against STH. At the end of the study, all children diagnosed as infected with a parasite will be treated according to national guidelines. If the prevalence of any parasite is over 50%, all children in the school will be treated according to national guidelines. In general, few and mild side effects are expected, the most common being stomach pain, diarrhea (watery stool), nausea, headache and dizziness.

Where is the study run from?
The study will be carried out at two schools on Pemba Island (Public Health Laboratory-Ivo de Carneri), United Republic of Tanzania.

When is the study starting and how long is it expected to run for?
August 2013 to December 2013

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
4057
Switzerland
-
jennifer.keiser@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy and safety of albendazole-OXantel pamoate, albendazole-mebendazole, albendazole-IVermectin and single MEBendazole in the treatment of Trichuris trichiura and concomitant Soil-Transmitted Helminth infections in Pemba: a randomized controlled trial

Acronym

OXIVMEB-STH

Study hypothesis

The three drug combinations (i.e. albendazole-oxantel pamoate, albendazole-mebendazole, and albendazole-ivermectin) achieve higher cure and egg reduction rates against T. trichiura infections compared to single-dose mebendazole (500 mg).

Ethics approval

1. Ethics Committee of Basel (Ethikkomission beider Basel [EKBB]), 02/07/2013, ref: 123/13
2. Ministry of Health and Social Welfare, 01/07/2013, ref: ZAMREC/0001/JUNE/013

Study design

Randomized controlled trial with four treatment arms

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

Group 1:
Albendazole (400 mg) + ivermectin (200 µg/kg)

Group 2:
Albendazole (400 mg) + mebendazole (500 mg)

Group 3:
Albendazole (400 mg) + oxantel pamoate (20 mg/kg)

Group 4:
Mebendazole (500 mg)

All interventions will be done on one day (single dose). This means that children from treatment group 1-3 receive albendazole together with either ivermectin, mebendazole, or oxantel pamoate, while treatment group 4 receives mebendazole.

Baseline and follow-up will last a maximum of 5 days (two stool samples collected over maximum 5 days).

Intervention type

Drug

Phase

Not Applicable

Drug names

Albendazole-oxantel, albendazole-ivermectin, albendazole-mebendazole, mebendazole

Primary outcome measures

Efficacy (cure rate and egg reduction rate) against T. trichiura

Secondary outcome measures

1. Adverse events observed with study drugs (before treatment, 2 and 24 hours after treatment).
2. The effect of the three drug combinations on infections with S. stercoralis, A. lumbricoides, A. duodenale, N. americanus. (Effect will be measured as reduction of eggs per gram of faeces [A. lumbricoides, A. duodenale, N. americanus] or if living larvae disappear after treatment from stool sample [S. stercoralis]. Measured at baseline and 3 weeks after treatment).
3. The clinical benefit of the tested drug combinations based on history of self-reported signs and symptoms, physical examination, and hemoglobin levels. (Measured at baseline [physical examination, questionnaire about general health using the visual analogue scale, and finger prick blood samples], 3 weeks after treatment [questionnaire about general health using the visual analogue scale], 3 months after treatment [physical examination, questionnaire about general health using the visual analogue scale, and finger prick blood samples].

Overall trial start date

15/08/2013

Overall trial end date

15/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent signed by parents and/or legal guardian; and oral assent by children (aged 6-14 years)
2. Able and willing to be examined by a study physician and answer a questionnaire about signs and symptoms at the beginning of the study, 3 weeks and 3 months after treatment
3. Able and willing to provide two stool samples at the beginning of the study, 3 weeks and 3 months after treatment
4. Able and willing to provide a urine sample and a finger prick blood sample before treatment and 3 months after treatment
5. Positive for T. trichiura (presence of eggs in stool) at the baseline parasitology survey
6. Absence of major systemic illnesses (e.g. clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment
7. No known or reported history of chronic illness such as cancer, diabetes, heart, liver or renal disease
8. No known allergy to study medications

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

440

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 drugs (within the past 4 weeks)
5. Attending other clinical trials during the study
6. Negative diagnostic result for T. trichiura (absence of eggs in stool) at baseline parasitological survey

Recruitment start date

15/08/2013

Recruitment end date

15/12/2013

Locations

Countries of recruitment

Tanzania

Trial participating centre

Swiss Tropical and Public Health Institute
Basel
4057
Switzerland

Sponsor information

Organisation

Swiss Tropical and Public Health Institute (Switzerland)

Sponsor details

c/o Prof Jennifer Keiser
Socinstr. 57
Basel
4057
Switzerland
-
jennifer.keiser@unibas.ch

Sponsor type

Research organisation

Website

http://www.swisstph.ch/

Funders

Funder type

Research organisation

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

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/25589326
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26935065

Publication citations

Additional files

Editorial Notes

03/03/2016: Publication reference added.