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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
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: 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
Parasitic Diseases
Protozoan Infections
Artesunate
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
Amebicides
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014