A Phase II/III, Randomized, Double-Blind, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa

Pfizer1 site238 target enrollmentJune 2004

ConditionsMalaria, Falciparum

DrugsAzithromycin/Chloroquine Mefloquine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Malaria, Falciparum
Sponsor: Pfizer
Enrollment: 238
Locations: 1
Primary Endpoint: Parasite clearance
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

May 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility 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 monoinfection, with asexual parasitemia between 1000 -100,000 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)
•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
•Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study

Exclusion Criteria

•Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness (e.g. obtundation, unarousable coma), seizures (any seizure within 24 hours prior to enrollment) or abnormal neurologic exam suggestive of severe or complicated malaria b.) Hemoglobinuria c.) Jaundice d.) Respiratory distress (respiratory rate \>= 30/min) e.) Persistent vomiting f.) Hematuria, as reported by the patient
•Presence of non-falciparum species on microscopy
•Pregnant or breast-feeding women
•History of allergy to or hypersensitivity to azithromycin or any macrolide, mefloquine or related compounds (e.g. quinine and quinidine), or chloroquine
•Known or suspected folate deficiency
•Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia)
•Known G-6PD deficiency
•History of epilepsy or psoriasis
•History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, 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.) Serum creatinine \>2.0 x ULN b.) ALT and/or AST \>3 x ULN