Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria
NCT ID: NCT01115439
Last Updated: 2012-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2010-03-31
2011-07-31
Brief Summary
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Detailed Description
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This is an observational study. Patients will receive the recommended treatment for P. falciparum malaria in Afghanistan (Nangarhar, Kunar, Thakhar, Faryab malaria control centers). The participants will be febrile children above six months of age and non-pregnant adults with confirmed uncomplicated P. falciparum infection. Patients will be treated with AS+SP according to standard dosing regimens. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy. The study will be conducted during the transmission season of falciparum malaria, i.e. October 2009 to January 2010 and September-December, 2010. Patients will be assessed clinically and via laboratory tests, particularly focussing on whether recurrences are recrudescences of the original infection or reinfections. All bio-medical findings will be recorded in specific patient case record forms and the electronic form of analyzed data as well as a final report will be sent to WHO-Afghanistan and National malaria control program offices for further actions. The patients will receive reasonable transportation costs for follow-up visits as well as one insecticide treated bed-net at the end of enrolment. The results of this study will be used to assist the Ministry of Health of Afghanistan in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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falciparum malaria
Febrile children (above six months of age) and non-pregnant adults with confirmed uncomplicated P. falciparum infection
artesunate plus sulfadoxine-pyrimethamine (AS+SP)
artesunate plus sulfadoxine-pyrimethamine (AS+SP)
Interventions
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artesunate plus sulfadoxine-pyrimethamine (AS+SP)
artesunate plus sulfadoxine-pyrimethamine (AS+SP)
Eligibility Criteria
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Inclusion Criteria
* Mono-infection with P. falciparum detected by microscopy at a level of 500-150,000/µL asexual forms
* Presence of axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C or history of fever during the past 24 h;
* ability to swallow oral medication;
* ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
* Informed consent from the patient or from a parent or guardian in the case of children under 18 years of age.
Exclusion Criteria
* Mixed or mono-infection with another Plasmodium species detected by microscopy
* Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm)
* Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
* Regular medication, which may interfere with antimalarial pharmacokinetics;
* History of hypersensitivity reactions or contraindications to any of the study medications;
* Female over 12 years of age
6 Months
ALL
No
Sponsors
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National Malaria and Leishmaniasis Control Program, Afghanistan
OTHER_GOV
World Health Organization
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Ghulam Rahim Awab, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit
Locations
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Provincial Malaria Control Centers (MRC)
Maymana, Faryab Province, Afghanistan
Provincial Malaria Control Centers (MRC)
Asadābād, Kunar, Afghanistan
Provincial Malaria Control Centers (MRC)
Jalalabad, Nangarhar, Afghanistan
Provincial Malaria Control Centers (MRC)
Taloqan, , Afghanistan
Countries
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References
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Awab GR, Imwong M, Pukrittayakamee S, Alim F, Hanpithakpong W, Tarning J, Dondorp AM, Day NP, White NJ, Woodrow CJ. Clinical trials of artesunate plus sulfadoxine-pyrimethamine for Plasmodium falciparum malaria in Afghanistan: maintained efficacy a decade after introduction. Malar J. 2016 Feb 25;15:121. doi: 10.1186/s12936-016-1167-z.
Other Identifiers
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BAKMAL1002
Identifier Type: -
Identifier Source: org_study_id