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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: NCT00203736
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 16, 2006
World Health Organization
Medical Research Council, South Africa
Global Fund
Information provided by:
University of Cape Town

Brief Summary:
The purpose of this study is to compare the efficacy of sulfadoxine-pyrimethamine plus artesunate with that of sulfadoxine-pyrimethamine on its own for 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 malaria control. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is an evaluation of the phased introduction of combination anti-malarial therapy (CAT) in Mozambique, Swaziland and South Africa. In order to facilitate formulation of effective regional drug policy and provide a database for decision-making on the implementation of CAT, it is essential that the in vivo response to CAT be investigated. This will be achieved through the SEACAT 01 protocol which is a component of the SEACAT evaluation described in another file on this website. However, in selected Mozambique sites where the intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate, AS, plus SP) will be conducted according to a specific amendment (Amendment 4) to the SEACAT 01 protocol. Amendment 4 is presented in this separate file on the website for clarity.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Drug Study (With Single and Parallel Group Components) to Evaluate Combination Antimalarial Therapy for Efficacy, Gametocyte Carriage and Molecular Markers Associated With SP Resistance in Uncomplicated Plasmodium Falciparum Infections
Study Start Date : January 2003
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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 frequency of DHFR and DHPS mutations with parasitological outcome
  4. Tolerability by describing adverse events and changes in haematological parameters
  5. Capacity by describing the training and development of study teams

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female, older than 12 months.
  • Weight > 10 kg.
  • Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 500 000 asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.50C or history of fever.
  • Documented informed consent.
  • Lives close enough to the health centre for reliable follow up.

Exclusion Criteria:

  • Has received anti-malarial treatment in the past 7 days.
  • Is infected with other malarial species (such subjects will be excluded retrospectively).
  • 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).
  • Has received cotrimoxazole or chloramphenicol in the past 7 days.
  • History of G6PD deficiency.
  • Is pregnant.
  • Has a history of allergy to any sulphonamide (for SP) or artemisinin derivative (for artesunate and co-artemether).

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): NCT00203736

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Catuane Clinic
Catuane, Matutuine, Mozambique
Namaacha Clinic
Namaacha, Mozambique
Sponsors and Collaborators
University of Cape Town
World Health Organization
Medical Research Council, South Africa
Global Fund
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Principal Investigator: Karen Barnes, MBChB University of Cape Town

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00203736     History of Changes
Other Study ID Numbers: SEACAT 01 Am 4 (RCT)
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:
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Parasitic Diseases
Protozoan Infections
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents