Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001049864
Ethics application status
Approved
Date submitted
27/09/2012
Date registered
2/10/2012
Date last updated
2/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of Artesunate plus Sulphadoxine-Pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in malaria control center Asadabad in Kunar province of Afghanistan
Scientific title
Efficacy and safety of Artesunate plus Sulphadoxine-Pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in malaria control center Asadabad in Kunar province of Afghanistan
Secondary ID [1] 281318 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
uncomplicated falciparum malaria 287531 0
Condition category
Condition code
Infection 287853 287853 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with a combiantion of artesunate plus sulphadoxine-pyrimethamine (AS plus SP) and observed for 42 days. Artesunate tablets (100 mg) will be administered orally once a day at a dose of 4 mg/kg per day for three consecutive days. Sulphadoxine-pyrimethamine tablets (500/25 mg) will be administered orally once a day for three days. The number of tablets to be administered is based on patient age /5-11 months = half tablet; 1-6 years = 1 tablet; 7-13 years= 2 tablets; 13 years and over = 3 tablets). The dosing regimen of artesunate plus sulphadoxine-pyrimethamine correspond to the standard of care for the treatment of acute uncomplicated malaria in Afghanistan.
Intervention code [1] 285779 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288075 0
Percent of treatment failures (early treatment failure + late clinical failure + late parasitological failure) as per latest WHO protocol on monitoring efficacy of antimalarial drug (WHO 2009)
Timepoint [1] 288075 0
Day 42 following initiation of treatment.
Secondary outcome [1] 299377 0
Percent of adverse events occurring after initiation of treatment whether considered related or not to the medicinal products. Known side effects include stomach discomfort and dizziness. Other rare or unexpected adverse events may occur and include allergic reaction, vomiting, headache and body ache, and convulsions. However, some adverse eventss may be disease-related.
Timepoint [1] 299377 0
Day 42 following initiation of treament

Eligibility
Key inclusion criteria
Age above 4 months, except females aged between 12 and 17 years
Mono-infection with P. falciparum detected by microscopy
Parasitemia 500-100,000 per microliter, asexual forms
Axillary or tympanic temperature greater than 37.5 C or history of fever during the past 24 hours
Ability to swallow oral medication
Ability and willingness to follow protocol procedures and visit schedule
Informed consent from patient or from parent or legal guardian for children under 16 years
Minimum age
4 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of general danger signs of severe malaria in children under 5 years
Mixed or mono-infection with another Palsmodium species
Pregnancy or breastfeeding
Presence of severe malnutrition
Presence of febrile conditions due to diseases other than malaria
Regular medication which may interfere with the antimalarial pharmacokinetics
History of hypersensitivity reactions or contraindications to any study medications.
Unable to or unwilling to take pregnancy test or contraceptives due to social-cultural reason

Study design
Purpose
Natural history
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment outside Australia
Country [1] 4576 0
Afghanistan
State/province [1] 4576 0

Funding & Sponsors
Funding source category [1] 286071 0
Government body
Name [1] 286071 0
World Health Organisation
Country [1] 286071 0
Switzerland
Primary sponsor type
Government body
Name
Research Department, Ministry of Publich Health, Afgahnistan
Address
3rd Floor of Main Building of Ministry of Public Health
Massoud Circle, Wazir Akbar Khan
Kabul
Country
Afghanistan
Secondary sponsor category [1] 284888 0
None
Name [1] 284888 0
Address [1] 284888 0
Country [1] 284888 0
Other collaborator category [1] 277100 0
University
Name [1] 277100 0
Mahidol Oxford Tropical Medicine Unit (MORU)
Address [1] 277100 0
Faculty of Tropical Medicine,
Mahidol University
60th Anniversary Charlermprakiat Building
420/6 Rajwithi Road
10400
Country [1] 277100 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288123 0
WHO ERC
Ethics committee address [1] 288123 0
20 Avenue Appia
CH1211 Geneva 27
Ethics committee country [1] 288123 0
Switzerland
Date submitted for ethics approval [1] 288123 0
Approval date [1] 288123 0
25/09/2012
Ethics approval number [1] 288123 0
RPC540

Summary
Brief summary
To monitor the efficacy of artesunate plus sulphadoxine-pyrimethamine in the treatment of uncomplicated falciparum malaria in the malaria control center Asadabad in Kunar province of Afghanistan
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34770 0
Address 34770 0
Country 34770 0
Phone 34770 0
Fax 34770 0
Email 34770 0
Contact person for public queries
Name 18017 0
Dr. Ghulam Rahim Awab
Address 18017 0
Research Department
Ministry of Public Health (MoPH) Afghanistan
3rd Floor of Main Building of Ministry of Public Health
Massoud Circle,
Wazir Akbar Khan
Kabul
Country 18017 0
Afghanistan
Phone 18017 0
+93 700044853
Fax 18017 0
Email 18017 0
[email protected]
Contact person for scientific queries
Name 8945 0
Dr. Ghulam Rahim Awab
Address 8945 0
Research Department
Ministry of Public Health (MoPH) Afghanistan
3rd Floor of Main Building of Ministry of Public Health
Massoud Circle,
Wazir Akbar Khan
Kabul
Country 8945 0
Afghanistan
Phone 8945 0
+93 700044853
Fax 8945 0
Email 8945 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.