NCT00203801

Brief Summary

The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
3 countries

7 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, 2002

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

3.5 years

First QC Date

August 29, 2005

Last Update Submit

October 17, 2018

Conditions

Malaria

Keywords

MalariaEfficacyPharmacokineticGametocyteMolecular markersSulfadoxine-pyrimethamineArtesunateArtemisinin

Outcome Measures

Primary Outcomes (6)

  • 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 glutamate-rich protein (GLURP) and merozoite surface protein (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, and lumefantrine should a reliable assay become available

  • Correlation of frequency of dihydropteroate synthase (DHFR) and dihydrofolate reductase (DHPS) mutations with parasitological outcome

  • Tolerability by describing adverse events and changes in haematological parameters

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

Interventions

Sulfadoxine-pyrimethamineDRUG
Artesunate plus sulfadoxine-pyrimethamineDRUG
Artemether-lumefantrineDRUG

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 uncomplicated acute P. falciparum malaria parasitaemia of up to 250 000 asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.5 or history of fever
  • Documented informed consent
  • Lives close enough to the health centre for reliable follow up

You may not qualify if:

  • Has received anti-malarial treatment in the past 7 days.
  • 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 Glucose-6-phosphate dehydrogenase (G6PD) deficiency (not a contra-indication for artemether-lumefantrine).
  • 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. artemether-lumefantrine).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ndzevane Clinic

Ndzevane, Eswatini

Location

Vuvulane Clinic

Vuvulane, Eswatini

Location

Bela Vista Clinic

Bela Vista, Matutuine, Mozambique

Location

Namaacha Clinic

Namaacha, Mozambique

Location

Ndumo Clinic

Ndumo, KwaZulu-Natal, South Africa

Location

Lulekani Clinic

Lulekani, Limpopo, South Africa

Location

Naas Clinic

Naas, Mpumalanga, South Africa

Location

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combinationArtesunateArtemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsArtemetherLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Karen Barnes, MBChB

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Karen I Barnes

Study Record Dates

First Submitted

August 29, 2005

First Posted

September 20, 2005

Study Start

January 1, 2002

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

October 19, 2018

Record last verified: 2018-10

Locations

ZA(3)ES(2)MO(2)