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.

Condition	Treatment or Intervention	Phase
Plasmodium falciparum Malaria	Drug: Azithromycin/Chloroquine  Drug: Sulfadoxine-Pyrimethamine/Chloroquine	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  219

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study ID Numbers:  A0661120
Record last reviewed:  February 2005
Last Updated:  February 15, 2005
Record first received:  December 22, 2003
ClinicalTrials.gov Identifier:  NCT00074841
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08