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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN79195095 |
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Date of registration:
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07/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Eritrea
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Scientific title:
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Date of first enrolment:
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03/09/2007 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN79195095 |
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Study type:
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Interventional |
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Study design:
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Clinical trial, surveillance, single arm study (Treatment)
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Phase:
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Countries of recruitment
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Eritrea
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Contacts
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Name:
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Pascal
Ringwald |
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Address:
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World Health Organization
20 Avenue Appia
CH-1211
Geneva 27
Switzerland |
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Telephone:
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+41 (0)22 791 34 69 |
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Email:
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ringwaldp@who.int |
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Affiliation:
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Name:
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Address:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
Infections and Infestations
Malaria
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Intervention(s)
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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
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Primary Outcome(s)
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To measure the clinical and parasitological efficacy (Adequate Clinical and Parasitological Response [ACPR]).
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Secondary Outcome(s)
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1. To differentiate recrudescence from new infections by the Polymerase Chain Reaction (PCR) analysis
2. To measure the clinical and parasitological efficacy PCR corrected
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Secondary ID(s)
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RPC239; Eritrea2
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Source(s) of Monetary Support
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World Health Organization (WHO) (Switzerland)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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