A Phase 2/3, Randomized, Comparative, Double Blind Trial Of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia

Pfizer0 sites32 target enrollmentMarch 2004

ConditionsMalaria, Falciparum

DrugsAzithromycin/Chloroquine Sulfadoxine-Pyrimethamine/Chloroquine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Malaria, Falciparum
Sponsor: Pfizer
Enrollment: 32
Primary Endpoint: parasite clearance
Status: Terminated
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.

Detailed Description

The trial was terminated prematurely 2 June 2005 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.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

April 2005

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•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 -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)
•Positive rapid diagnostic test (Binax NOW ICT) for P. falciparum
•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, seizures or abnormal neurologic exam b.) Jaundice c.) Respiratory distress d.) Persistent vomiting e.) Hematuria, as reported by the patient f.) Parasite density \> 100,000 parasites/mL g.) Presence of non-falciparum species on microscopy
•Pregnant or breast-feeding women
•History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine
•Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia)
•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
•Inability to swallow oral medication in tablet form
•Treatment with other investigational drugs within 30 Days prior to enrollment into the study
•Alcohol and/or any other drug abuse