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

This study has been terminated.
Information provided by:
Pfizer Identifier:
First received: May 12, 2004
Last updated: April 25, 2011
Last verified: April 2011
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Parasite clearance

Secondary Outcome Measures:
  • tolerability

Enrollment: 14
Study Start Date: August 2004
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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00082563

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information Identifier: NCT00082563     History of Changes
Other Study ID Numbers: A0661121
Study First Received: May 12, 2004
Last Updated: April 25, 2011

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents
Anthelmintics processed this record on April 28, 2017