NCT00203814

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

November 16, 2006

Status Verified

August 1, 2005

First QC Date

September 13, 2005

Last Update Submit

November 15, 2006

Conditions

Malaria

Keywords

MalariaEfficacyPharmacokineticGametocyteMolecular markersSulfadoxine-pyrimethamineArtesunateArtemisinin

Outcome Measures

Primary Outcomes (5)

  • 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

  • Fever clearance time

Secondary Outcomes (5)

  • Association between study treatment and gametocyte carriage

  • Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine

  • Correlation of the frequency of DHFR and DHPS mutations with parasitological outcome

  • Tolerability by describing adverse events and changes in haematological parameters

  • Capacity building by describing the training and development of study teams and their subsequent skills attained

Interventions

Sulfadoxine-pyrimethamineDRUG
Artesunate plus sulfadoxine-pyrimethamineDRUG

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boane Clinic

Boane, Maputo Province, Mozambique

Location

Magude Clinic

Magude, Mozambique

Location

Related Publications (1)

  • 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.

    PMID: 19558654DERIVED

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combinationArtesunate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Karen Barnes, MBChB

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Study Completion

March 1, 2005

Last Updated

November 16, 2006

Record last verified: 2005-08

Locations

MO(2)