Malaria
Conditions
Keywords
Malaria, Efficacy, Pharmacokinetic, Gametocyte, Molecular Markers, Sulfadoxine-pyrimethamine, Artesunate, Artemisinin
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.
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.
Interventions
DRUGSulfadoxine-pyrimethamine
Sponsors
World Health Organization
Medical Research Council, South Africa
Global Fund
University of Cape Town
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, older than 12 months. * Weight \> 10 kg. * 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. * 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. * Is infected with other malarial species (such subjects will be excluded retrospectively). * 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. * Is pregnant. * Has a history of allergy to any sulphonamide (for SP) or artemisinin derivative (for artesunate and co-artemether).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fever clearance time | — |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Mozambique
Outcome results
None listed