A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

University of Cape Town (UCT)

Status

Completed

Conditions

Malaria

Treatments

Drug: Sulfadoxine-pyrimethamine

Drug: Artesunate plus sulfadoxine-pyrimethamine

Study type

Interventional

Funder types

Other

Identifiers

NCT00203736

SEACAT 01 Am 4 (RCT)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

12+ months old

Volunteers

No Healthy Volunteers

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).