A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria
Study Details
Study Description
Brief Summary
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 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 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.
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 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 []
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 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).
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Documented informed consent.
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Lives close enough to the study site 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 may be excluded retrospectively from the analysis).
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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) or other danger signs.
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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.
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History of G6PD deficiency.
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Is pregnant or breastfeeding.
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Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole, other artemisinin derivatives e.g. co-artemether).
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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
Locations
Site | City | State | Country | Postal Code | |
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1 | Boane Clinic | Boane | Maputo | Mozambique | |
2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SEACAT 01a ASSP