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
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