Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America
NCT00084227
ABOUT THIS STUDY
FOR MORE INFORMATION
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Pfizer Clinical Trials Contact Center
1-800-718-1021
- Written informed consent of the subject or a legally authorized representative
- 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 - 40,000 parasites/mL; b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F 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
- Subjects must be willing to be treated in the inpatient setting for a minimum of three days or more until parasitemia has cleared and the Investigator deems the subject fit for discharge
- Women of childbearing potential (that is, women who have not been surgically sterilized or are not clearly post-menopausal), must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study and for one month after the last study visit
- Severe or complicated malaria including subjects with any of the following: a.)
Impaired consciousness (e.g. obtundation, unarousable coma, delirium, stupor),
seizures (any seizure within a 24 hour prior to enrollment) or abnormal neurologic
exam suggestive of severe or complicated malaria b.) Hemoglobinuria c.) Jaundice d.)
Respiratory distress (respiratory rate ≥ 30 breaths/minute) 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,
atovaquone, proguanil or chloroquine
- Concomitant administration of rifampin or rifabutin and metoclopramide
- History of epilepsy or psoriasis
- History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine,
atovaquone/proguanil, sulfadoxine/pyrimethamine, 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.) Known or suspected
creatinine clearance <30 mL/min b.) ALT and/or AST > 3 x upper limit of normal
- Inability to swallow oral medication in tablet or capsule 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 follow to the study protocol
- Prior participation in this study
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Descriptive Information | ||||
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Brief Title ICMJE | Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America | |||
Official Title ICMJE | A Phase Ii/Iii, Randomized, Double Blind, Comparative Trial Of Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America | |||
Brief Summary | The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to P. falciparum. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Malaria, Falciparum | |||
Intervention ICMJE |
| |||
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 | 244 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | July 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | Not Provided | |||
Removed Location Countries | Colombia, Suriname | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00084227 | |||
Other Study ID Numbers ICMJE | A0661126 | |||
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 |
| |||
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 |