Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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PLASMODIUM FALCIPARUM MALARIA

Intervention / Treatment
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* Drug: Azithromycin/Chloroquine
* Drug: Sulfadoxine-Pyrimethamine/Chloroquine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin/Chloroquine|nan|
|Drug: Sulfadoxine-Pyrimethamine/Chloroquine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MALARIA, INDIA, CHLOROQUINE, PLASMODIUM FALCIPARUM, SULFADOXINE-PYRIMETHAMINE