A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malaria

Keywords

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Malaria Efficacy Pharmacokinetic Gametocyte Molecular markers Sulfadoxine-pyrimethamine Artesunate Artemisinin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sulfadoxine-pyrimethamine

Intervention Type DRUG

Artesunate plus sulfadoxine-pyrimethamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, older than 12 months.
* Weight \> 10 kg.
* 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).
* Documented informed consent.
* Lives close enough to the study site for reliable follow up.

Exclusion Criteria

* Has received anti-malarial treatment in the past 7 days.
* Is infected with other malarial species (such subjects may be excluded retrospectively from the analysis).
* 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.
* 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.
* History of G6PD deficiency.
* 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. co-artemether).
* 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.

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Karen Barnes, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

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Boane Clinic

Boane, Maputo Province, Mozambique

Site Status

Magude Clinic

Magude, , Mozambique

Site Status

Countries

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Mozambique

References

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Allen EN, Little F, Camba T, Cassam Y, Raman J, Boulle A, Barnes KI. Efficacy of sulphadoxine-pyrimethamine with or without artesunate for the treatment of uncomplicated Plasmodium falciparum malaria in southern Mozambique: a randomized controlled trial. Malar J. 2009 Jun 26;8:141. doi: 10.1186/1475-2875-8-141.

Reference Type DERIVED

PMID: 19558654 (View on PubMed)

Other Identifiers

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SEACAT 01a ASSP

Identifier Type: -

Identifier Source: org_study_id