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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Malaria Efficacy Pharmacokinetic Gametocyte Molecular Markers Sulfadoxine-pyrimethamine Artesunate Artemisinin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sulfadoxine-pyrimethamine

Intervention Type DRUG

Artesunate plus sulfadoxine-pyrimethamine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karen Barnes, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Catuane Clinic

Catuane, Matutuine, Mozambique

Site Status

Namaacha Clinic

Namaacha, Namaacha, Mozambique

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mozambique

References

Explore related publications, articles, or registry entries linked to this study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

SEACAT 01 Am 4 (RCT)

Identifier Type: -

Identifier Source: org_study_id