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
Pakistan 1
Study information
Scientific title
Acronym
Study hypothesis
1. To evaluate the proportion of patients with early treatment failure (ETF), late clinical failure (LTF), late parasitological failure (LPF), or with an adequate clinical and parasitological response (ACPR) as indicators of efficacy
2. To evaluate the incidence of adverse events
3. To formulate recommendations and to enable the Directorate of Malaria Control (DOMC) in the Ministry of Health to make informed decisions about the possible need for updating of the current national antimalarial treatment guidelines
Ethics approval
Ethics approval received from:
1. World Health Organization (WHO) Ethics Review Committee (ERC) on the 16th January 2008 (ref: RPC254)
2. Ministry of Health (Pakistan) on the 1st December 2007 (ref: F.1-4/2003-ST)
Study design
One arm non-blinded clinical surveillance trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malaria
Intervention
Artesunate 4 mg/kg/day over three days and sulfadoxine-pyrimethamine 25 mg/kg and 1.25 mg/kg single dose. The treatment is three days and the follow up is 28 days.
Contact details for Principal Investigator:
Dr Faisal Mansoor
23c Sabir House
Faisbad Rawalpindi
Islamabad
Pakistan
Tel: +92 (0)51 441 5494
Email: faisalmansoor100@gmail.com
Intervention type
Drug
Phase
Not Specified
Drug names
Artesunate, sulfadoxine-pyrimethamine
Primary outcome measures
1. To evaluate the proportion of patients with early treatment failure (ETF), late clinical failure (LTF), late parasitological failure (LPF), or with an adequate clinical and parasitological response (ACPR) as indicators of efficacy
2. To evaluate the incidence of adverse events
The outcome measure is at day 28 except if the patient fails or is lost to follow-up or withdrawn from the study.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
21/01/2008
Overall trial end date
06/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged over six months old, either sex
2. Uncomplicated mono-infection with Plasmodium falciparum
3. Parasitaemia, 1,000 - 100,000 asexual forms per µl
4. Axillary temperature greater than or equal to 37.5°C or oral/rectal temperature of greater than or equal to 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
Other
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Presence of general danger signs among children less than five 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 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 mothers (if adults included)
Recruitment start date
21/01/2008
Recruitment end date
06/01/2009
Locations
Countries of recruitment
Pakistan
Trial 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
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