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02 September 2010
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| [ Print-friendly version ] |
| Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Eritrea |
| ISRCTN | ISRCTN79195095 |
| ClinicalTrials.gov identifier | |
| Public title | Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Eritrea |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | RPC239; Eritrea2 |
| Study hypothesis | 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 |
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) |
| Study design | Clinical trial, surveillance, single arm study |
| Countries of recruitment | Eritrea |
| Disease/condition/study domain | Malaria |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 03/09/2007 |
| Anticipated end date | 03/03/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 180 |
| Interventions |
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 |
| Primary outcome measure(s) | To measure the clinical and parasitological efficacy (Adequate Clinical and Parasitological Response [ACPR]). |
| Secondary outcome measure(s) |
1. To differentiate recrudescence from new infections by the Polymerase Chain Reaction (PCR) analysis
2. To measure the clinical and parasitological efficacy PCR corrected |
| Sources of funding | World Health Organization (WHO) (Switzerland) |
| Trial website | |
| Publications | |
| Contact name | Dr Pascal Ringwald |
| Address |
World Health Organization
20 Avenue Appia |
| City/town | Geneva 27 |
| Zip/Postcode | CH-1211 |
| Country | Switzerland |
| Tel | +41 (0)22 791 34 69 |
| Fax | +41 (0)22 791 48 24 |
| ringwaldp@who.int | |
| Sponsor | World Health Organization (WHO) (Switzerland) |
| Address | 20 Avenue Appia |
| City/town | Geneva 27 |
| Zip/Postcode | CH-1211 |
| Country | Switzerland |
| Tel | +41 (0)22 791 34 69 |
| Fax | +41 (0)22 791 48 24 |
| ringwaldp@who.int | |
| Sponsor website: | http://www.who.int/malaria/ |
| Date applied | 07/09/2007 |
| Last edited | 15/10/2008 |
| Date ISRCTN assigned | 07/09/2007 |
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