Contact information
Type
Scientific
Contact name
Dr Pascal Ringwald
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva 27
CH-1211
Switzerland
+41 (0)22 791 34 69
ringwaldp@who.int
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
RPC239; Eritrea2
Study information
Scientific title
Acronym
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(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)
Study design
Clinical trial, surveillance, single arm study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Artemether-lumefantrine
Primary outcome measure
To measure the clinical and parasitological efficacy (Adequate Clinical and Parasitological Response [ACPR]).
Secondary outcome measures
1. To differentiate recrudescence from new infections by the Polymerase Chain Reaction (PCR) analysis
2. To measure the clinical and parasitological efficacy PCR corrected
Overall study start date
03/09/2007
Overall study end date
03/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Other
Sex
Both
Target number of participants
180
Participant 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
Recruitment start date
03/09/2007
Recruitment end date
03/03/2008
Locations
Countries of recruitment
Eritrea, Switzerland
Study participating centre
World Health Organization
Geneva 27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO) (Switzerland)
Sponsor details
20 Avenue Appia
Geneva 27
CH-1211
Switzerland
+41 (0)22 791 34 69
ringwaldp@who.int
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|