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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01115439
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : July 12, 2012
Sponsor:
Collaborators:
National Malaria and Leishmaniasis Control Program, Afghanistan
World Health Organization
Information provided by (Responsible Party):
University of Oxford

Study Description
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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.

Condition or disease Intervention/treatment
Falciparum Malaria Drug: artesunate plus sulfadoxine-pyrimethamine (AS+SP)

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 Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : March 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Groups and Cohorts
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Group/Cohort Intervention/treatment
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)
artesunate plus sulfadoxine-pyrimethamine (AS+SP)


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients experiencing therapeutic failure [ Time Frame: 42 days ]
    Proportion of patients experiencing therapeutic failure


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Febrile children (above six months of age) and non-pregnant adults with confirmed uncomplicated P. falciparum infection
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115439


Locations
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Afghanistan
Provincial Malaria Control Centers (MRC)
Maimana, Faryab, Afghanistan
Provincial Malaria Control Centers (MRC)
Asadabad, Kunar, Afghanistan
Provincial Malaria Control Centers (MRC)
Jalalabad, Nangarhar, Afghanistan
Provincial Malaria Control Centers (MRC)
Taloqan, Afghanistan
Sponsors and Collaborators
University of Oxford
National Malaria and Leishmaniasis Control Program, Afghanistan
World Health Organization
Investigators
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Principal Investigator: Ghulam Rahim Awab, MD Mahidol Oxford Research Unit
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01115439    
Other Study ID Numbers: BAKMAL1002
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012
Keywords provided by University of Oxford:
falciparum malaria
artemisinin combination treatments
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Artesunate
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary