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

NCT00084227 | Completed Phase 2

• 1 other identifier: A0661126
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malaria, Falciparum

Outcome Measures

Primary Outcomes (1)

• parasite clearance

Secondary Outcomes (1)

• tolerability and safety

Interventions

Azithromycin/Chloroquine DRUG

Atovaquone/Proguanil DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Azithromycin; Chloroquine; atovaquone, proguanil drug combination

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2004
• First Posted: June 11, 2004
• Study Start: July 1, 2004
• Study Completion: July 1, 2005
• Last Updated: May 11, 2011

Record last verified: 2011-05