Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00084227
First received: June 9, 2004
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.


Condition Intervention Phase
Malaria, Falciparum
Drug: Azithromycin/Chloroquine
Drug: Atovaquone/Proguanil
Phase 2
Phase 3

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/Iii, Randomized, Double Blind, Comparative Trial Of Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • parasite clearance

Secondary Outcome Measures:
  • tolerability and safety

Enrollment: 244
Study Start Date: July 2004
Study Completion Date: July 2005
  Eligibility

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

Inclusion Criteria:

  • Written informed consent of the subject or a legally authorized representative
  • Females and males >= 18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 - 40,000 parasites/mL; b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours
  • Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection)
  • Positive rapid diagnostic test (Binax NOW ICT) positive for P. falciparum
  • Subjects must be willing to be treated in the inpatient setting for a minimum of three days or more until parasitemia has cleared and the Investigator deems the subject fit for discharge
  • Women of childbearing potential (that is, women who have not been surgically sterilized or are not clearly post-menopausal), must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study and for one month after the last study visit

Exclusion Criteria:

  • Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness (e.g. obtundation, unarousable coma, delirium, stupor), seizures (any seizure within a 24 hour prior to enrollment) or abnormal neurologic exam suggestive of severe or complicated malaria b.) Hemoglobinuria c.) Jaundice d.) Respiratory distress (respiratory rate ≥ 30 breaths/minute) e.) Persistent vomiting f.) Hematuria, as reported by the patient
  • Pregnant or breast-feeding women
  • History of allergy to or hypersensitivity to azithromycin or any macrolide, atovaquone, proguanil or chloroquine
  • Concomitant administration of rifampin or rifabutin and metoclopramide
  • History of epilepsy or psoriasis
  • History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, atovaquone/proguanil, sulfadoxine/pyrimethamine, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study
  • Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) Known or suspected creatinine clearance <30 mL/min b.) ALT and/or AST > 3 x upper limit of normal
  • Inability to swallow oral medication in tablet or capsule form
  • Treatment with other investigational drugs within 30 days prior to enrollment into the study
  • Alcohol and/or any other drug abuse
  • Requirement to use medication during the study that might interfere with the evaluation of the study drug
  • Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug
  • Inability to comprehend and/or unwillingness follow to the study protocol
  • Prior participation in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084227

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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00084227     History of Changes
Other Study ID Numbers: A0661126
Study First Received: June 9, 2004
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections
Atovaquone
Atovaquone, proguanil drug combination
Chloroquine
Chloroquine diphosphate
Proguanil
Amebicides
Analgesics
Analgesics, Non-Narcotic
Anthelmintics
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimalarials
Antimetabolites
Antinematodal Agents
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Filaricides
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on October 29, 2014