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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2006

Last Updated Date

August 12, 2009

Start Date ^ICMJE

March 2006

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00282919 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

An assessment of the safety and tolerability of the treatment regimen.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Falciparum Malaria

Intervention ^ICMJE

Drug: Azithromycin plus chloroquine

dose of 2000 mg Azithromycin plus 600 mg chloroquine base

Study Arm (s)

Experimental: Azithromycin plus chloroquine

Single Arm, Open label study

Intervention: Drug: Azithromycin plus chloroquine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

110

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Colombia, India

Administrative Information

NCT Number ^ICMJE

NCT00282919

Other Study ID Numbers ^ICMJE

A0661154

Has Data Monitoring Committee

Yes

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

August 2009

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

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