A Phase II/III, Randomized, Comparative Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in India
Data Collection
Vector Borne Diseases+4
+ Mosquito-Borne Diseases
+ Infections
Treatment Study
Summary
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.230 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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/uL; b.) Fever or history of fever ( \>=38.5C/101.2F rectal or tympanic; \>=37.5C/99.5F axillary or \>=38C/100.4F 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 * 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 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 * Pregnant or breast-feeding women * History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, 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 * 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 * 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 to follow the study protocol * Prior participation in this study
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Pfizer Investigational Site
Bambolim, IndiaPfizer Investigational Site
Nagpur, IndiaPfizer Investigational Site
Parel Mumbai, India