A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

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. Identifier: NCT00203814
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 16, 2006
World Health Organization
Medical Research Council, South Africa
Information provided by:
University of Cape Town

Brief Summary:
The purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria.

Condition or disease Intervention/treatment Phase
Malaria Drug: Sulfadoxine-pyrimethamine Drug: Artesunate plus sulfadoxine-pyrimethamine Not Applicable

Detailed Description:
Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In order to facilitate formulation of effective regional drug policies and to provide a database for decision-making on the implementation of combination therapy (CAT), it is essential that the in vivo response to CAT be investigated. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is a comprehensive evaluation of the phased introduction of combination anti-malarial therapy in Mozambique. As a component of this evaluation, in selected Mozambique sites where intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate plus SP) will be conducted according to this protocol.

Study Type : Interventional  (Clinical Trial)
Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Randomised, Parallel Group in Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy (CAT), Artesunate and Sulfadoxine-Pyrimethamine Versus Sulfadoxine-Pyrimethamine Alone, in Terms of Therapeutic Efficacy, Prevalence of Gametocyte Carriage and Prevalence of Molecular Markers Associated With SP Resistance In Uncomplicated Plasmodium Falciparum Infections.
Study Start Date : January 2004
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Primary Outcome Measures :
  1. Therapeutic efficacy defined as:Adequate Clinical and Parasitological Response (ACPR), Early Treatment Failure (ETF), Late Treatment Failure (LTF), defined as Late Clinical Failure (LCF) and Late Parasitological Failure (LPF)
  2. Sensitive or parasitological failure (RI, early and late, RII, RIII)
  3. Parasitological failures will be classified as recrudescence or re-infection (or indeterminate) using GLURP and MSP I & II markers
  4. Parasite clearance time
  5. Fever clearance time

Secondary Outcome Measures :
  1. Association between study treatment and gametocyte carriage
  2. Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine
  3. Correlation of the frequency of DHFR and DHPS mutations with parasitological outcome
  4. Tolerability by describing adverse events and changes in haematological parameters
  5. Capacity building by describing the training and development of study teams and their subsequent skills attained

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, older than 12 months.
  • Weight > 10 kg.
  • Diagnoses of pure uncomplicated acute P. falciparum malaria parasitaemia of up to 500 000 asexual parasite/mcl blood with axillary temperature of greater than or equal to 37.5°C or history of fever (defined as within the previous 24 hours).
  • Documented informed consent.
  • Lives close enough to the study site for reliable follow up.

Exclusion Criteria:

  • Has received anti-malarial treatment in the past 7 days.
  • Is infected with other malarial species (such subjects may be excluded retrospectively from the analysis).
  • Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated) or other danger signs.
  • Has received cotrimoxazole, trimethoprim, chloramphenicol, folate or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
  • History of G6PD deficiency.
  • Is pregnant or breastfeeding.
  • Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole, other artemisinin derivatives e.g. co-artemether).
  • Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.

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 identifier (NCT number): NCT00203814

Boane Clinic
Boane, Maputo, Mozambique
Magude Clinic
Magude, Mozambique
Sponsors and Collaborators
University of Cape Town
World Health Organization
Medical Research Council, South Africa
Principal Investigator: Karen Barnes, MBChB University of Cape Town

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00203814     History of Changes
Other Study ID Numbers: SEACAT 01a ASSP
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 16, 2006
Last Verified: August 2005

Keywords provided by University of Cape Town:
Molecular markers

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents