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

NCT ID: NCT00282919

Last Updated: 2014-06-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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Conditions

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Falciparum Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin plus chloroquine

Single Arm, Open label study

Group Type EXPERIMENTAL

Azithromycin plus chloroquine

Intervention Type DRUG

dose of 2000 mg Azithromycin plus 600 mg chloroquine base

Interventions

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Azithromycin plus chloroquine

dose of 2000 mg Azithromycin plus 600 mg chloroquine base

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Tumaco, Departamento de NariƱo, Colombia

Site Status

Pfizer Investigational Site

Bambolim, Goa, India

Site Status

Countries

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Colombia India

Related Links

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Other Identifiers

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A0661154

Identifier Type: -

Identifier Source: org_study_id

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