A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

Malaria Clinical Trial

Official title:

Open Label Drug Study (With Single and Parallel Group Components) to Evaluate Combination Antimalarial Therapy for Efficacy, Gametocyte Carriage and Molecular Markers Associated With SP Resistance in Uncomplicated Plasmodium Falciparum Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203736
• Other study ID #: SEACAT 01 Am 4 (RCT)
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 15, 2006
• Start date: January 2003
• Est. completion date: October 2003

Study information

• Verified date: August 2005
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mozambique: Ministry of Health (MISAU)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Sulfadoxine-pyrimethamine

• Artesunate plus sulfadoxine-pyrimethamine

Locations

Country	Name	City	State
Mozambique	Catuane Clinic	Catuane	Matutuine
Mozambique	Namaacha Clinic	Namaacha

Sponsors (4)

Lead Sponsor	Collaborator
University of Cape Town	Global Fund, Medical Research Council, South Africa, World Health Organization

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Sensitive or parasitological failure (RI, early and late, RII, RIII)
Primary	Parasitological failures will be classified as recrudescence or re-infection (or indeterminate) using GLURP and MSP I & II markers
Primary	Parasite clearance time
Primary	Fever clearance time
Secondary	Association between study treatment and gametocyte carriage
Secondary	Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine
Secondary	Correlation of frequency of DHFR and DHPS mutations with parasitological outcome
Secondary	Tolerability by describing adverse events and changes in haematological parameters
Secondary	Capacity by describing the training and development of study teams