Condition category
Infections and Infestations
Date applied
20/02/2009
Date assigned
30/03/2009
Last edited
30/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

Department of Medical Parasitology and Infection Biology
Swiss Tropical Institute
Basel
4054
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Artemether in the treatment of Fasciola hepatica and/or Fasciola gigantica infections in Egypt: an open-label non-randomised proof of concept trial

Acronym

AM-Fasciola

Study hypothesis

Artemether shows efficacy against Fasciola hepatica and/or Fasciola gigantica.

Ethics approval

1. Switzerland: Ethics Committee of Basel(EKBB Ethikkomission beider Basel), approved on 12/03/2007 (ref: 54/07)
2. Egypt: Theodor Bilharz Research Institute Institutional Review Board, approved on 20/12/2006 (ref: FWA 000010609)

The study has also received an approval from the Ministry of Health and Population, Cairo.

Study design

Interventional open-label non-randomised proof of concept trial, consisting of 2 x single-arm studies

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Fascioliasis

Intervention

This trial consisted of two separate single-arm studies. Study 1 and 2 involved different subjects.

Study 1: 22 patients were given 80 mg artemether (oral) twice daily for 3 days
Study 2: 19 patients received 200 mg artemether (oral) three times within 24 hours (morning, lunch, evening) (duration of intervention: 1 day)

Intervention type

Drug

Phase

Not Applicable

Drug names

Artemether

Primary outcome measures

Cure rate and egg reduction rate at 28 days post treatment.

Secondary outcome measures

Adverse events. Patient were monitored for 3 hours after each dose.

Overall trial start date

01/04/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, age 11-70 years
2. For married females, not pregnant, as assessed by the medical doctor last menstrual cycle, upon initial clinical assessment
3. Absence of major systemic illnesses, as assessed by the medical doctor, upon initial clinical assessment
4. Infection with F. hepatica and/or F. gigantica as confirmed by standard parasitological stool examination
5. No known or reported hypersensitivity to artemether
6. No known or reported history of chronical illness such as cancer, diabetes, hypertension, chronic heart, liver or renal disease
7. Full clinical examination
8. Written informed consent

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Presence of any abnormal medical condition, judged by the medical doctor. If several patients experience serious adverse events the study will be stopped.
2. Severe liver disease of other aetiology
3. Recent history of anthelminthic drugs (triclabendazole, albendazole, bithionol, dehydroemetine, praziquantel within past 4 weeks)
4. Attending other clinical trials during the study
5. For females: pregnancy, lactation

Recruitment start date

01/04/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Egypt

Trial participating centre

Department of Medical Parasitology and Infection Biology
Basel
4054
Switzerland

Sponsor information

Organisation

Swiss Tropical Institute (Switzerland)

Sponsor details

o/c Prof Jennifer Keiser
Basel
4054
Switzerland

Sponsor type

Government

Website

http://www.sti.ch/

Funders

Funder type

Other

Funder name

Velux Foundation (Velux Stiftung) (Switzerland)

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

Publication citations

Additional files

Editorial Notes