A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
Medical Research Council, South Africa
Global Fund
Information provided by:
University of Cape Town
ClinicalTrials.gov Identifier:
NCT00203736
First received: September 13, 2005
Last updated: November 15, 2006
Last verified: August 2005
  Purpose

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 Intervention
Malaria
Drug: Sulfadoxine-pyrimethamine
Drug: Artesunate plus sulfadoxine-pyrimethamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • 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)
  • Sensitive or parasitological failure (RI, early and late, RII, RIII)
  • Parasitological failures will be classified as recrudescence or re-infection (or indeterminate) using GLURP and MSP I & II markers
  • Parasite clearance time
  • Fever clearance time

Secondary Outcome Measures:
  • Association between study treatment and gametocyte carriage
  • Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine
  • Correlation of frequency of DHFR and DHPS mutations with parasitological outcome
  • Tolerability by describing adverse events and changes in haematological parameters
  • Capacity by describing the training and development of study teams

Estimated Enrollment: 240
Study Start Date: January 2003
Estimated Study Completion Date: October 2003
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.

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203736

Locations
Mozambique
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
Investigators
Principal Investigator: Karen Barnes, MBChB University of Cape Town
  More Information

No publications provided by University of Cape Town

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00203736     History of Changes
Other Study ID Numbers: SEACAT 01 Am 4 (RCT)
Study First Received: September 13, 2005
Last Updated: November 15, 2006
Health Authority: Mozambique: Ministry of Health (MISAU)

Keywords provided by University of Cape Town:
Malaria
Efficacy
Pharmacokinetic
Gametocyte
Molecular Markers
Sulfadoxine-pyrimethamine
Artesunate
Artemisinin

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Antimalarials
Pyrimethamine
Sulfadoxine
Artesunate
Sulfadoxine-pyrimethamine
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 April 17, 2014