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Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India Clinical research trials and Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India. Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India clinical trial. Participants oftentimes recieve the most expert healthcare available for their Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India  Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India
Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India
For Condition: Plasmodium falciparum Malaria
Status: Recruiting
Sponsor(s): Pfizer ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Active Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 219
Location and Contact Information:
Pfizer Investigational Site *Recruiting*
Dispur Guwahati, Assam, 781006
India
Recruiting
Pfizer Investigational Site *Recruiting*
Rourkela, Orissa, 769005
India
Recruiting
Pfizer Investigational Site *Recruiting*
Bambolim, Gao, 403002
India
Recruiting
Pfizer Investigational Site *Recruiting*
Parel Mumbai, Maharashtra, 400012
India
Recruiting
Additional Information:
Study ID Numbers: A0661120;
Study Start Date: September 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074841
Other Plasmodium Falciparum Malaria Studies:
1. Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India
2. Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Uganda
3. Azithromycin in Combination with Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum Infection in Semi-Immune Adults
Related Studies:
Other Plasmodium falciparum Malaria Clinical Trials
Other Assam Clinical Trials
Other Dispur Guwahati Clinical Trials
Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in India
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