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

ISRCTN ISRCTN10372301
DOI https://doi.org/10.1186/ISRCTN10372301
Secondary identifying numbers N/A
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

Study designInterventional open-label non-randomised proof of concept trial, consisting of 2 x single-arm studies
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific titleArtemether in the treatment of Fasciola hepatica and/or Fasciola gigantica infections in Egypt: an open-label non-randomised proof of concept trial
Study acronymAM-Fasciola
Study objectivesArtemether 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) studiedFascioliasis
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Artemether
Primary outcome measureCure rate and egg reduction rate at 28 days post treatment.
Secondary outcome measuresAdverse events. Patient were monitored for 3 hours after each dose.
Overall study start date01/04/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Egypt
  • Switzerland

Study participating centre

Department of Medical Parasitology and Infection Biology
Basel
4054
Switzerland

Sponsor information

Swiss Tropical Institute (Switzerland)
Government

o/c Prof Jennifer Keiser
Basel
4054
Switzerland

Website http://www.sti.ch/
ROR logo "ROR" https://ror.org/03adhka07

Funders

Funder type

Other

Velux Foundation (Velux Stiftung) (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan