Artemether in the treatment of Fasciola hepatica and/or Fasciola gigantica infections in Egypt

ISRCTN	ISRCTN10372301
DOI	https://doi.org/10.1186/ISRCTN10372301
Protocol serial number	N/A
Sponsor	Swiss Tropical Institute (Switzerland)
Funder	Velux Foundation (Velux Stiftung) (Switzerland)

Submission date: 20/02/2009
Registration date: 30/03/2009
Last edited: 30/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jennifer Keiser
Scientific

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

Study information

Primary study design	Interventional
Study design	Interventional open-label non-randomised proof of concept trial, consisting of 2 x single-arm studies
Secondary study design	Non randomised controlled trial
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
Study acronym	AM-Fasciola
Study objectives	Artemether shows efficacy against Fasciola hepatica and/or Fasciola gigantica.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Artemether
Primary outcome measure(s)	Cure rate and egg reduction rate at 28 days post treatment.
Key secondary outcome measure(s)	Adverse events. Patient were monitored for 3 hours after each dose.
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	01/04/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Egypt
Switzerland

Study participating centre

Department of Medical Parasitology and Infection Biology

Basel
4054
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan