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

NCT01115439 | Completed

• 1 other identifier: BAKMAL1002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Falciparum Malaria

Keywords

falciparum malaria; artemisinin combination treatments

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing therapeutic failure

  Proportion of patients experiencing therapeutic failure

  42 days

Study Arms (1)

falciparum malaria

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

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

Interventions

artesunate plus sulfadoxine-pyrimethamine (AS+SP) DRUG

artesunate plus sulfadoxine-pyrimethamine (AS+SP)

falciparum malaria

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• National Malaria and Leishmaniasis Control Program, Afghanistan: collaborator
• World Health Organization: collaborator

Study Sites (4)

Provincial Malaria Control Centers (MRC)

Maymana, Faryab Province, Afghanistan

Location

Provincial Malaria Control Centers (MRC)

Asadābād, Kunar, Afghanistan

Location

Provincial Malaria Control Centers (MRC)

Jalalabad, Nangarhar, Afghanistan

Location

Provincial Malaria Control Centers (MRC)

Taloqan, Afghanistan

Location

Related Publications (1)

• 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.

  PMID: 26917051 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Artesunate; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Ghulam Rahim Awab, MD

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: May 4, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

AF (4)