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
Scientific
Department of Medical Parasitology and Infection Biology
Swiss Tropical Institute
Basel
4054
Switzerland
Study information
| 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 |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Artemether |
| Primary outcome measure | 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 study start date | 01/04/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
4054
Switzerland
Sponsor information
Swiss Tropical Institute (Switzerland)
Government
Government
o/c Prof Jennifer Keiser
Basel
4054
Switzerland
| Website | http://www.sti.ch/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
