Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria (ASPF)

• ClinicalTrials.gov Identifier: NCT01115439
• Recruitment Status: Completed
• First Posted: May 4, 2010
• Last Update Posted: July 12, 2012
• Sponsor: University of Oxford
• Collaborators: National Malaria and Leishmaniasis Control Program, Afghanistan; World Health Organization
• Information provided by (Responsible Party): University of Oxford

Tracking Information

• First Submitted Date: March 29, 2010
• First Posted Date: May 4, 2010
• Last Update Posted Date: July 12, 2012
• Study Start Date: March 2010
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 30, 2010)

Proportion of patients experiencing therapeutic failure [ Time Frame: 42 days ]

Proportion of patients experiencing therapeutic failure

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria
• Official Title: Efficacy and Safety of Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Malaria Control Centers in Nangarhar, Kunar, Thakhar and Faryab Provinces of Afghanistan
• Brief Summary: In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium falciparum resistance to chloroquine (80%) and more recently an increasing degree of resistance to sulfadoxine-pyrimethamine monotherapy (12%). In 2003 the high failure rate of chloroquine against falciparum malaria led the national malaria treatment programme to switch its recommended first line drug treatment for uncomplicated Plasmodium falciparum malaria to artemisinin-based combination therapy (ACT) in the form of Artesunate/Sulfadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7 days). The aim of this study is to conduct ongoing monitoring of the efficacy of the new combination against P. falciparum in a group of sentinel sites in Afghanistan.

Detailed Description

The objective of the study is to assess the efficacy and safety of Artesunate/Sulfadoxine-Pyrimethamine (AS+SP) for the treatment of uncomplicated P. falciparum infections in Nangarhar, Kunar, Thakhar, Faryab malaria control centers in Afghanistan.

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Febrile children (above six months of age) and non-pregnant adults with confirmed uncomplicated P. falciparum infection
• Condition: Falciparum Malaria

Intervention

Drug: artesunate plus sulfadoxine-pyrimethamine (AS+SP)

artesunate plus sulfadoxine-pyrimethamine (AS+SP)

Study Groups/Cohorts

falciparum malaria

Febrile children (above six months of age) and non-pregnant adults with confirmed uncomplicated P. falciparum infection

Intervention: Drug: artesunate plus sulfadoxine-pyrimethamine (AS+SP)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 30, 2010): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion:

• Age over six months.
• 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:

• Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of the World Health Organization (WHO)
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Afghanistan

Administrative Information

• NCT Number: NCT01115439
• Other Study ID Numbers: BAKMAL1002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Oxford
• Original Responsible Party: Charlie Woodrow, University of Oxford
• Current Study Sponsor: University of Oxford
• Original Study Sponsor: Same as current

Collaborators

• National Malaria and Leishmaniasis Control Program, Afghanistan
• World Health Organization

Investigators

• Principal Investigator: Ghulam Rahim Awab, MD; Mahidol Oxford Research Unit

• PRS Account: University of Oxford
• Verification Date: July 2012