A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria
Study Details
Study Description
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 |
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N/A |
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.
Study Design
Outcome Measures
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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, older than 12 months.
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Weight > 10 kg.
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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.
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Documented informed consent.
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Lives close enough to the health centre for reliable follow up.
Exclusion Criteria:
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Has received anti-malarial treatment in the past 7 days.
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Is infected with other malarial species (such subjects will be excluded retrospectively).
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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).
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Has received cotrimoxazole or chloramphenicol in the past 7 days.
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History of G6PD deficiency.
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Is pregnant.
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Has a history of allergy to any sulphonamide (for SP) or artemisinin derivative (for artesunate and co-artemether).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Catuane Clinic | Catuane | Matutuine | Mozambique | |
2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SEACAT 01 Am 4 (RCT)