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

NCT00074841

Last updated date
Study Location
Pfizer Investigational Site
Dispur Guwahati, Assam, 781006, India
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
PLASMODIUM FALCIPARUM MALARIA
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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PLASMODIUM FALCIPARUM MALARIATrial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India NCT00074841
  1. Dispur Guwahati, Assam
  2. Bambolim, Gao
  3. Nagpur, Maharashtra
  4. Parel Mumbai, Maharashtra
  5. Rourkela, Orissa
  6. Vellore, Tamil Nadu
  7. Indore,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE PLASMODIUM FALCIPARUM MALARIA
Intervention  ICMJE
  • Drug: Azithromycin/Chloroquine
  • Drug: Sulfadoxine-Pyrimethamine/Chloroquine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2011)
230
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
219
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00074841
Other Study ID Numbers  ICMJE A0661120
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP