Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Eritrea
| ISRCTN | ISRCTN79195095 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79195095 |
| Protocol serial number | RPC239; Eritrea2 |
| Sponsor | World Health Organization (WHO) (Switzerland) |
| Funder | World Health Organization (WHO) (Switzerland) |
- Submission date
- 07/09/2007
- Registration date
- 07/09/2007
- Last edited
- 15/10/2008
- 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
Dr Pascal Ringwald
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva 27
CH-1211
Switzerland
| Phone | +41 (0)22 791 34 69 |
|---|---|
| ringwaldp@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Clinical trial, surveillance, single arm study |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study objectives | The general objective of this study is to assess the therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria in three sentinel sites in Eritrea. |
| Ethics approval(s) | Ethics approval gained from: 1. Ministry of Health Eritrea on the 18th July 2007 (ref: 15124/6716/07) 2. Research Ethics Review Committee of the World Health Organization (ERC WHO) on the 28th August 2007 (ref: RPC239) |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Artemether and lumefantrine six doses over three days orally (per os) according to manufacturer recommendations. As this is a surveilllance study there is no control group. Contact details of Principal Investigator: Dr Tewolde Ghebremeskel Woldeghabir Ministry of Health Asmarat P.O. Box 212 Eritrea Tel: +291 (0)1 125 529 Fax: +291 (0)1 122 899 Email: tewoldeg@moh.gov.er or tewoldeg2003@yahoo.com |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artemether-lumefantrine |
| Primary outcome measure(s) |
To measure the clinical and parasitological efficacy (Adequate Clinical and Parasitological Response [ACPR]). |
| Key secondary outcome measure(s) |
1. To differentiate recrudescence from new infections by the Polymerase Chain Reaction (PCR) analysis |
| Completion date | 03/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 180 |
| Key inclusion criteria | 1. All ages, 6 months and above 2. Single infection with P. falciparum 3. Parasitaemia of 1,000 - 100, 000 asexual forms per µl 4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C, or history of fever in the previous 24 hours 5. Ability to swallow oral medication 6. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule 7. Informed consent from the patient or from a parent or guardian in case of children |
| Key exclusion criteria | 1. Presence of general danger signs among children less than 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions 2. Mixed or mono-infection with another Plasmodium species 3. Presence of severe malnutrition defined as a child whose weight-for-height is below 3 Standard Deviation (SD) 4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, Human Immunodeficiency Virus [HIV]/Acquired Immune Deficiency Syndrome [AIDS]) 5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment 6. Pregnancy or positive pregnancy test or lactating |
| Date of first enrolment | 03/09/2007 |
| Date of final enrolment | 03/03/2008 |
Locations
Countries of recruitment
- Eritrea
- Switzerland
Study participating centre
World Health Organization
Geneva 27
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
