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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00084227

Collaborator

(none)

244

Enrollment

Duration (Months)

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

244 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

Jul 1, 2004

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

parasite clearance []

Secondary Outcome Measures

tolerability and safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 â‰¥ 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