Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum
This study has been terminated.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00082563
First received: May 12, 2004
Last updated: April 25, 2011
Last verified: April 2011
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:
MedlinePlus related topics:
Malaria
Drug Information available for:
Chloroquine phosphate
Chloroquine
Chloroquine sulfate
Chloroquine hydrochloride
Azithromycin
Azithromycin dihydrate
Azithromycin monohydrate
U.S. FDA Resources
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 |
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
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00082563 History of Changes |
| Other Study ID Numbers: | A0661121 |
| Study First Received: | May 12, 2004 |
| Last Updated: | April 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Azithromycin Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials |
Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013