Contact information
Type
Scientific
Primary contact
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 number
ClinicalTrials.gov number
Protocol/serial number
RPC220
Study information
Scientific title
Acronym
Study hypothesis
To assess the efficacy of the first (artesunate and sulfadoxine-pyrimethamine) and second line treatment (artemether-lumefantrine) for the treatment of uncomplicated Plasmodium falciparum infections in different sentinel sites in Sudan.
Ethics approval
Ethics approval received from:
1. Federal Ministry of Health (Sudan) on the 3rd May 2007
2. Ethical Research Committee of the World Health Organization (WHO) on the 11th June 2007 (ref: RPC220)
Study design
One-arm surveillance study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Malaria
Intervention
Each patient will receive both:
1. Artemether-lumefantrine six consecutive doses according to manufacturer recommendation over three days orally (per os)
2. Artesunate 12 mg/kg over three days per os and sulfadoxine-pyrimethamine 1/2 tablet 500 mg - 25 mg/10 kg single dose per os
Principal Investigator:
Dr Khalid A. Elmardi
National Malaria Control Programme
Federal Ministry of Health
P.O. Box 1204
Khartoum
Sudan
Tel: +249 (0)183 776809
Fax: +249 (0)183 770397
Email: khalidmrd9@hotmail.com
Intervention type
Drug
Phase
Not Specified
Drug names
Artesunate, sulfadoxine-pyrimethamine, artemether-lumefantrine
Primary outcome measure
Adequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected.
Secondary outcome measures
Incidence of adverse events.
Overall trial start date
01/08/2007
Overall trial end date
30/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 6 months old
2. Infection with P. falciparum
3. Parasitaemia, 1000 - 100 000 asexual forms per µl
4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C
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
Patient
Age group
Not Specified
Gender
Not Specified
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 or who has symmetrical oedema involving at least the feet)
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
5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
6. Pregnancy or lactation
Recruitment start date
01/08/2007
Recruitment end date
30/11/2007
Locations
Countries of recruitment
Sudan
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO)/HIV/AIDS, Tuberculosis and Malaria (HTM) - Global Malaria Programme
Sponsor details
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Sudan)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list