NCT00493363

Brief Summary

There are worrying signs that parasitological responses to the artemisinin drugs for uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to artesunate are poor it is essential to have characterised the blood concentration profile as well as the parasitological response to differentiate resistance from abnormal pharmacokinetics. The primary objective of the study is to assess the level of resistance to artemisinin derivatives in Western Cambodia. A detailed evaluation of 2 different artesunate containing regimens in patients with uncomplicated malaria will be performed. Patients will be randomised to receive either a) Artesunate 2mg/kg/day for 7 days or b) Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4 The effect on parasite clearance and cure will be assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

2.5 years

First QC Date

June 27, 2007

Last Update Submit

May 1, 2018

Conditions

Falciparum Malaria

Keywords

falciparum malariaartemisininsartesunateresistance

Outcome Measures

Primary Outcomes (1)

  • parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD)

    parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD)

    June 2008

Secondary Outcomes (1)

  • 56 day cure rates, in vitro sensitivity, molecular markers of drug resistance

    June 2008

Study Arms (2)

arm 1

EXPERIMENTAL
Drug: Artesunate

arm 2

ACTIVE COMPARATOR
Drug: Artesunate + Mefloquine

Interventions

ArtesunateDRUG

Artesunate 2 mg/kg/day for 7 days

arm 1
Artesunate + MefloquineDRUG

Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4

arm 2

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • They or their parents/guardians give fully informed consent.
  • They are not pregnant.
  • They have not received antimalarial drugs in the previous 48 hours.
  • P.falciparum parasitaemia exceeds 10,000/uL

You may not qualify if:

  • Mixed infection (such as vivax malaria), history of allergy to artesunate or mefloquine, any sign of severe disease according to WHO criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pailin Referal Hospital

Pailin, Cambodia

Location

Related Publications (3)

  • Mechri M, Epaud R, Emond S, Coulomb A, Jaubert F, Tarrant A, Feldmann D, Flamein F, Clement A, de Blic J, Taam RA, Brunelle F, le Pointe HD. Surfactant protein C gene (SFTPC) mutation-associated lung disease: high-resolution computed tomography (HRCT) findings and its relation to histological analysis. Pediatr Pulmonol. 2010 Oct;45(10):1021-9. doi: 10.1002/ppul.21289.

    PMID: 20658481DERIVED

  • Anderson TJ, Nair S, Nkhoma S, Williams JT, Imwong M, Yi P, Socheat D, Das D, Chotivanich K, Day NP, White NJ, Dondorp AM. High heritability of malaria parasite clearance rate indicates a genetic basis for artemisinin resistance in western Cambodia. J Infect Dis. 2010 May 1;201(9):1326-30. doi: 10.1086/651562.

    PMID: 20350192DERIVED

  • Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009 Jul 30;361(5):455-67. doi: 10.1056/NEJMoa0808859.

    PMID: 19641202DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

ArtesunateMefloquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Nicholas J White, DSc,FRCP,FRS

    Oxford University/ Mahidol University

    PRINCIPAL INVESTIGATOR

  • Duong Socheat, MD

    National Malaria Control Programme Cambodia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

CA(1)