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
Information provided by:
University of Cape Town
ClinicalTrials.gov Identifier:
NCT00203814
First received: September 13, 2005
Last updated: November 15, 2006
Last verified: August 2005
  Purpose

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 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, 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.

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 the frequency of DHFR and DHPS mutations with parasitological outcome
  • Tolerability by describing adverse events and changes in haematological parameters
  • Capacity building by describing the training and development of study teams and their subsequent skills attained

Estimated Enrollment: 280
Study Start Date: January 2004
Estimated Study Completion Date: March 2005
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.

  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203814

Locations
Mozambique
Boane Clinic
Boane, Maputo, Mozambique
Magude Clinic
Magude, Mozambique
Sponsors and Collaborators
University of Cape Town
World Health Organization
Medical Research Council, South Africa
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: NCT00203814     History of Changes
Other Study ID Numbers: SEACAT 01a ASSP
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 16, 2014