A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282919
First received: January 26, 2006
Last updated: August 12, 2009
Last verified: August 2009

January 26, 2006
August 12, 2009
March 2006
February 2008   (final data collection date for primary outcome measure)
To confirm the hypothesis that a dose of 2000 mg Azithromycin plus 600 mg chloroquine base each day for three days is highly efficacious for the treatment of symptomatic, uncomplicated P. falciparum. [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
To confirm the hypothesis that a dose of 2000 mg Azithromycin plus 600 mg chloroquine base each day for three days is highly efficacious for the treatment of symptomatic, uncomplicated P. falciparum.
Complete list of historical versions of study NCT00282919 on ClinicalTrials.gov Archive Site
  • Asexual P. falciparum parasite clearance time [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • Fever clearance time [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • An assessment of the safety and tolerability of the treatment regimen [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • % Early Treatment Failures (ETF) [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • % Late Treatment Failures (LTF) [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • Resistance as measured by RI, RII, RIII [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • Clinical cure rates at 3, 7, 28, and 42 days [ Time Frame: at 3, 7, 28, and 42 days ] [ Designated as safety issue: No ]
  • P. falciparum gametocyte absence rate at 7, 14, 21, 28, 35 and 42 days [ Time Frame: 7, 14, 21, 28, 35 and 42 days ] [ Designated as safety issue: No ]
  • Asexual P. falciparum parasite clearance rate at 7, 14, 21, 35 and 42 days [ Time Frame: 7, 14, 21, 35 and 42 days ] [ Designated as safety issue: No ]
An assessment of the safety and tolerability of the treatment regimen.
Not Provided
Not Provided
 
A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
A Phase 2, Open Label, Non-Comparative Trial Of Azithromycin 2000 mg Plus Chloroquine 600 Mg Base Daily For Three Days For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria

The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Falciparum Malaria
Drug: Azithromycin plus chloroquine
dose of 2000 mg Azithromycin plus 600 mg chloroquine base
Experimental: Azithromycin plus chloroquine
Single Arm, Open label study
Intervention: Drug: Azithromycin plus chloroquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P. falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38 C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.

Exclusion Criteria:

  • Subjects with severe or complicated malaria. Pregnant or breast feeding women.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   India
 
NCT00282919
A0661154
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP