NCT00356005

Brief Summary

The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for phase_2

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

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

July 24, 2006

Last Update Submit

October 31, 2012

Conditions

Uncomplicated Falciparum Malaria

Keywords

falciparum malariatherapyazithromycinartesunateCoartemBangladesh

Outcome Measures

Primary Outcomes (1)

  • Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.

    42 days

Secondary Outcomes (1)

  • Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).

    42

Study Arms (2)

Azithromycin + Artesunate

EXPERIMENTAL

Azithromycin + Artesunate treatment

Drug: azithromycin plus artesunate

Artesunate

ACTIVE COMPARATOR

Artesunate treatment controls

Drug: Artesunate

Interventions

azithromycin plus artesunateDRUG
Azithromycin + Artesunate
ArtesunateDRUG
Artesunate

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 with a parasite density of 100 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5ºC), or reported history of fever within the last 48 hours.
  • Age: 8-65 years old
  • Males or females. All females over the age of 12 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, such as implant, injectable, oral contraceptive(s) with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study
  • Written informed consent obtained
  • Willing to stay under close medical supervision for the study duration
  • Otherwise healthy outpatients

You may not qualify if:

  • Mixed malaria infection on admission by malaria smear
  • A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin, or lumefantrine or to drugs with similar chemical structures
  • Malaria drug therapy administered in the past 30 days by history
  • Previous participation in this trial, or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
  • 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 2003)
  • Unable and/or unlikely to comprehend and/or follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadar Hospital

Bāndarban, Bangladesh

Location

Related Publications (1)

  • Thriemer K, Starzengruber P, Khan WA, Haque R, Marma AS, Ley B, Vossen MG, Swoboda P, Akter J, Noedl H. Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial. J Infect Dis. 2010 Aug 15;202(3):392-8. doi: 10.1086/653710.

    PMID: 20557237DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

AzithromycinArtesunate

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Rashidul Haque, MBBS,PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

  • Harald Noedl, MD, MCTM,PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

August 1, 2006

Primary Completion

August 1, 2007

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

BA(1)