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Sponsored by: |
Rib-X Pharmaceuticals, Inc. |
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Information provided by: | Rib-X Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00640926 |
The purpose of this study is to determine whether RX-1741, an oxazolidinone antibiotic, is safe and effective in the treatment of mild to moderate community acquired pneumonia
Condition | Intervention | Phase |
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Community Acquired Pneumonia |
Drug: RX-1741 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of RX-1741 in the Treatment of Adult Patients With Mild to Moderate Severity of Community-Acquired Pneumonia (CAP) |
Enrollment: | 160 |
Study Start Date: | October 2007 |
Study Completion Date: | April 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
300 mg RX-1741
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Drug: RX-1741
300 mg/day, orally for 7-10 days
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2: Experimental
450 mg RX-1741
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Drug: RX-1741
450 mg/day orally for 7-10 days
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3: Experimental
900 mg RX-1741
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Drug: RX-1741
900 mg/day orally for 7-10 days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients requiring immediate study drug therapy before serology or culture results are known may be entered with a presumptive diagnosis of CAP based on: A chest radiograph at baseline, which shows a new infiltrate(s) consistent with pneumonia as interpreted by the radiologist or the investigator and subsequently confirmed by the radiologist.
AND at least 2 of the following signs and symptoms:
New or increased cough. Purulent sputum or change in sputum character. Auscultatory findings consistent with pneumonia. New onset or progressive dyspnea or tachypnea. Fever >38ºC oral or >38.5ºC tympanic. White blood cell (WBC) count greater than 10,000 cells/mm3 or >15% immature neutrophils (bands), regardless of total peripheral WBC count, or less than 4,500 cells/mm3.
Patient must be able to swallow large capsules intact.
A written, voluntarily signed informed consent must be obtained from the patient prior to the initiation of any study-related procedures.
Exclusion Criteria:
long-acting penicillin within 28 days of enrollment azithromycin, ceftriaxone, or telithromycin within 14 days prior to enrollment any other antibiotics for >24 hours within 3 days of enrollment
Responsible Party: | Rib-X Pharmaceuticals, Inc. ( Scott Hopkins, MD ) |
Study ID Numbers: | RX-1741-201 |
Study First Received: | March 18, 2008 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00640926 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Pneumonia |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Pneumonia |