Contact information
Type
Scientific
Primary contact
Dr Pascal Ringwald
ORCID ID
Contact details
World Health Organization
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3469
ringwaldp@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC243
Study information
Scientific title
Acronym
Study hypothesis
Monitor efficacy and safety of artesunate and sulfadoxine-pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of vivax malaria.
Ethics approval
Ethics approval received from:
1. Ministry of Public Health Afghanistan on the 15th September 2007
2. World Health Organization (WHO) Ethics Review Committee (ERC) on the 13th November 2007 (ref: RPC 243)
Study design
One arm non-comparative study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Malaria
Intervention
1. Artesunate (12 mg/kg) and sulfadoxine (25 mg/kg single dose) - pyrimethamine (1.25 mg/kg single dose) over 3 days for falciparum malaria
2. Chloroquine 25 mg/kg over 3 days for vivax malaria
Contact details for Principal Investigator:
Dr Ghulam Rahim Awab
District/Phase - 4
Jalalabad City
Nangarhar
Afghanistan
Tel: +93 (0)70 004 4853
Email: awabgr@yahoo.com
Intervention type
Drug
Phase
Not Specified
Drug names
Artesunate, sulfadoxine-pyrimethamine, chloroquine
Primary outcome measures
1. To measure the clinical and parasitological efficacy of artesunate and sulfadoxine-pyrimethamine among patients aged above six months suffering from uncomplicated falciparum malaria and chloroquine for vivax malaria, by determining the proportion of patients with:
1.1. Early Treatment Failure (ETF)
1.2. Late Clinical Failure (LTF)
1.3. Late Parasitological Failure (LPF)
1.4. Adequate Clinical and Parasitological Response (ACPR)
As indicators of efficacy
2. To differentiate recrudescences from new infections by the Polymerase Chain Reaction (PCR) analysis
3. To evaluate the incidence of adverse events
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/11/2007
Overall trial end date
01/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age above 6 months
2. Mono-infection with P. falciparum or P. vivax
3. Parasitaemia, 1000 - 100,000 asexual forms per µl for falciparum malaria and above 250 asexual forms per µl for vivax malaria
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
Child
Gender
Both
Target number of participants
300
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 (see Annex 1)
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 less than 70% of the median of the National Center for Health Statistics [NCHS]/WHO normalised reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] less than 110 mm)
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. Positive pregnancy test or lactating (if adults included)
Recruitment start date
15/11/2007
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Afghanistan
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO) (Switzerland)
Sponsor details
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3469
ringwaldp@who.int
Sponsor type
Research organisation
Website
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
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
Results - basic reporting
Publication summary