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

This study has been completed.
Sponsor:
Collaborators:
National Malaria and Leishmaniasis Control Program, Afghanistan
World Health Organization
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01115439
First received: March 29, 2010
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Proportion of patients experiencing therapeutic failure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Proportion of patients experiencing therapeutic failure


Enrollment: 100
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115439

Locations
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
Principal Investigator: Ghulam Rahim Awab, MD Mahidol Oxford Research Unit
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01115439     History of Changes
Other Study ID Numbers: BAKMAL1002
Study First Received: March 29, 2010
Last Updated: July 11, 2012
Health Authority: Afghanistan: Ministry of Public Health

Keywords provided by University of Oxford:
falciparum malaria
artemisinin combination treatments

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Artesunate
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on July 20, 2014