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.
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
Pfizer Investigational Site, Indore 452001, India
Pfizer Investigational Site, Dispur Guwahati, Assam 781006, India
Pfizer Investigational Site, Bambolim, Gao 403002, India
Pfizer Investigational Site, Nagpur, Maharashtra 440 018, India
Pfizer Investigational Site, Parel Mumbai, Maharashtra 400012, India
Pfizer Investigational Site, Rourkela, Orissa 769005, India
Pfizer Investigational Site, Vellore, Tamil Nadu 632 004, India
