NCT00639873

Brief Summary

A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

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

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

1.4 years

First QC Date

March 14, 2008

Last Update Submit

August 22, 2013

Conditions

Malaria

Keywords

Uncomplicated P. falciparum malaria

Outcome Measures

Primary Outcomes (1)

  • Cure

    Cure is defined as adequate clinical and parasitological response (ACPR) as opposed to early treatment failure / late treatment failure

    42 days

Secondary Outcomes (1)

  • Treatment response

    42 Days

Study Arms (3)

AS 2mg/kg

EXPERIMENTAL

Artesunate monotherapy 2mg/kg/day for 7 days

Drug: Artesunate

AS 4mg/kg

EXPERIMENTAL

Artesunate monotherapy 4mg/kg/day for 7 days

Drug: Artesunate

QD Control

ACTIVE COMPARATOR

Quinine-doxycycline for 7 days

Drug: quinine-doxycycline

Interventions

ArtesunateDRUG

2 or 4 mg/kg/day for 7 days

AS 2mg/kgAS 4mg/kg
quinine-doxycyclineDRUG

quinine-doxycycline for 7 days

QD Control

Eligibility Criteria

Age8 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Acute symptomatic falciparum malaria infection as determined by malaria smear with a parasite density of 1,000 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5C), or reported history of fever within the last 48 hours.
  • Age: 8-65 years old
  • All females between the age of 12 and 50 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception throughout the study
  • Written informed consent obtained
  • Willing to stay under close medical supervision for the study duration of 42 days
  • Otherwise healthy outpatients

You may not qualify if:

  • Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception
  • Mixed malaria infection on admission by malaria smear
  • A previous history of intolerance or hypersensitivity to the study drugs or to drugs with similar chemical structures
  • Malaria drug therapy administered in the past 30 days by history
  • History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
  • Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
  • Signs or symptoms of severe malaria (as defined by WHO 2000)
  • Unable and/or unlikely to comprehend and/or follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandarban Sadar Hospital

Bandarban Sadar, Bandarban, Bangladesh

Location

Related Publications (1)

  • Starzengruber P, Swoboda P, Fuehrer HP, Khan WA, Hofecker V, Siedl A, Fally M, Graf O, Teja-Isavadharm P, Haque R, Ringwald P, Noedl H. Current status of artemisinin-resistant falciparum malaria in South Asia: a randomized controlled artesunate monotherapy trial in Bangladesh. PLoS One. 2012;7(12):e52236. doi: 10.1371/journal.pone.0052236. Epub 2012 Dec 18.

    PMID: 23272227DERIVED

Related Links

MeSH Terms

Conditions

Malaria

Interventions

Artesunate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Harald Noedl, MD, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

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
Assoc. Prof. Dr.

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

August 23, 2013

Record last verified: 2013-08

Locations

BA(1)