A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00282919

Purpose

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

Condition	Intervention	Phase
Falciparum Malaria	Drug: Azithromycin plus chloroquine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Chloroquine diphosphate Chloroquine Azithromycin Chloroquine hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	110
Study Start Date:	March 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Azithromycin plus chloroquine: Experimental Single Arm, Open label study	Drug: Azithromycin plus chloroquine dose of 2000 mg Azithromycin plus 600 mg chloroquine base

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282919

Locations

Colombia, Narino
Pfizer Investigational Site
San Andres de Tumaco, Narino, Colombia
India, Goa
Pfizer Investigational Site
Bambolim, Goa, India, 403002

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661154
Study First Received:	January 26, 2006
Last Updated:	August 12, 2009
ClinicalTrials.gov Identifier:	NCT00282919 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Physiological Effects of Drugs
Malaria
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Sensory System Agents
Therapeutic Uses
Azithromycin
Parasitic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Amebicides

Analgesics
Antinematodal Agents
Protozoan Infections
Coccidiosis
Filaricides
Chloroquine
Anthelmintics
Pharmacologic Actions
Malaria, Falciparum
Analgesics, Non-Narcotic
Chloroquine diphosphate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010