Combination Antimalarials in 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:
NCT00203801
First received: August 29, 2005
Last updated: September 7, 2006
Last verified: August 2005

August 29, 2005
September 7, 2006
January 2002
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00203801 on ClinicalTrials.gov Archive Site
  • Association between study treatment and gametocyte carriage
  • Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine, and lumefantrine should a reliable assay become available
  • 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 and their subsequent skills attained
Same as current
Not Provided
Not Provided
 
Combination Antimalarials in Uncomplicated Malaria
An Open Label In Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy (CAT),in Terms of Therapeutic Efficacy, Prevalence of Gametocyte Carriage and Prevalence of Molecular Markers Associated With SP Resistance in Uncomplicated Plasmodium Falciparum Infections.

The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.

The resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there will be a comprehensive evaluation of phased introduction of combination anti-malarials (CAT) in Mozambique, Swaziland and South Africa. In order to facilitate formulation of an effective regional drug policy and provide a database for decision-making on the implementation of combination therapy, it is essential that the in vivo response to CAT in all three countries be investigated. An SP therapeutic efficacy study will be conducted according to this modified WHO protocol to guide the selection of CAT. After CAT is introduced an in vivo CAT efficacy study will then be conducted to evaluate the efficacy of artesunate plus SP (or artemether-lumefantrine in KwaZulu Natal and Limpopo). In areas of low intensity malaria transmission the CAT in vivo study results will be compared across sites and with those found at baseline with monotherapy, for each site.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
  • Drug: Sulfadoxine-pyrimethamine
  • Drug: Artesunate plus sulfadoxine-pyrimethamine
  • Drug: Artemether-lumefantrine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
July 2005
Not Provided

Inclusion Criteria:

  • Male or female, older than 12 months.
  • Weight > 10 kg.
  • Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 250 000 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.
  • 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 (not a contra-indication for artemether-lumefantrine).
  • 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. artemether-lumefantrine).
Both
12 Months and older
No
Contact information is only displayed when the study is recruiting subjects
Mozambique,   South Africa,   Swaziland
 
NCT00203801
SEACAT 01 Mono (Am 1,2,3,5,6)
Not Provided
Not Provided
University of Cape Town
  • World Health Organization
  • Medical Research Council, South Africa
  • Global Fund
Principal Investigator: Karen Barnes, MBChB University of Cape Town
University of Cape Town
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP