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Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum

This study has been terminated.

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00082563
  Purpose

The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.


Condition Intervention Phase
Malaria, Falciparum
Drug: Azithromycin/Chloroquine
Drug: Chloroquine
Phase II

MedlinePlus related topics:   Malaria   

Drug Information available for:   Azithromycin    Chloroquine    Chloroquine diphosphate    Chloroquine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase II, Randomized, Comparative Trial Of Azithromycin In Combination With Chloroquine Versus Chloroquine In The Eradication Of Asymptomatic Plasmodium Falciparum Infection In Semi-Immune Adults

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Parasite clearance

Secondary Outcome Measures:
  • tolerability

Estimated Enrollment:   80
Study Start Date:   August 2004
Estimated Study Completion Date:   November 2004

Detailed Description:

The trial was terminated prematurely 9 November 2004 due to the inability to recruit the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Healthy adult: male or female
  • Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 - 30,000 parasites/μL
  • Age 18 years to 60 years
  • Willingness to sign and ability to understand consent form
  • Willingness and ability to return for scheduled follow up visits

Exclusion Criteria:

  • Mixed malaria infection by Giemsa smear
  • History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin)
  • Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study
  • Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting)
  • Inability to swallow oral medication
  • Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality
  • Any situation which could prevent the patient from returning to follow up visits
  • Pregnancy or breast feeding
  • Any other concurrent illness that may confound the result
  • Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082563

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    
  More Information


Link to ClinicalStudyResults.org Posting  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   A0661121
First Received:   May 12, 2004
Last Updated:   June 12, 2008
ClinicalTrials.gov Identifier:   NCT00082563
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Protozoan Infections
Chloroquine diphosphate
Azithromycin
Chloroquine
Parasitic Diseases
Malaria
Malaria, Falciparum

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Filaricides
Coccidiosis
Physiological Effects of Drugs
Anthelmintics
Pharmacologic Actions
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Amebicides
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Antinematodal Agents

ClinicalTrials.gov processed this record on November 20, 2008




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