Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia

Completed · Phase 2

Conditions studied: Community-Acquired Pneumonia (CAP)

In brief

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 (CAP).

Key facts

Study ID: NCT00640926
Run by: Melinta Therapeutics, Inc.
People needed: 158
Starts: 2007-10-01
Expected to finish: 2009-04-01
Last updated by the study team: 2016-05-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult patients with mild to moderate CAP.
Adult men and women ≥18 years.
Females must be post-menopausal for at least 1 year or surgically sterile (hysterectomy or tubal ligation).
Sexually active males must use a barrier method of birth control during and for 30 days after the study. Their female partner should also use an additional reliable method of contraception during and for 30 days after the study.
The patient must present with an acute respiratory illness (≤7 days duration) with which history and physical examination is consistent with a diagnosis of CAP.
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.

You may not qualify if…

Hypersensitivity to linezolid.
Patients are excluded if they have taken oral or parenteral antibiotics as follows:
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
Require parenteral antibiotics for the treatment for CAP.
Patient should not have been hospitalized or resided in a long-term facility for at least 14 days before the onset of symptoms.
Evidence of other pulmonary disease that precluded evaluation of therapeutic response. Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not exclude patients who have chronic obstructive pulmonary disease).
Experienced a recent clinically significant coagulopathy.
History of cystic fibrosis, active tuberculosis, meningitis, endocarditis, or osteomyelitis.
Immunocompromised patients including, but not limited to patients with a CD4+ cell count of <350 cells/mm3 secondary to human immunodeficiency virus (HIV) infection, neutropenic patients with granulocytes <1000/mm3 or immunosuppression secondary to drugs such as corticosteroid therapy (>10 mg/day of prednisone or equivalent for at least the past 3 months), splenectomized patients or patients with known hyposplenia or asplenia.
Patients who have severe liver disease.
Treatment with an investigational drug within 4 weeks prior to study drug administration.
Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluation of the absorption of study drug.
Patients with bronchiectasis and a history of recent respiratory infection caused by Pseudomonas aeruginosa.
Any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug.
Patients taking serotonergic agents, selective serotonin reuptake inhibitors (SSRIs) or monoamine oxidase inhibitors (MAOIs).

Where it is running

eStudySite — San Diego, California, United States
Olive View- UCLA Center, Dept. Emergency Medicine — Sylmar, California, United States
Wayne State University School of Medicine/Detroit Receiving Hospital — Detroit, Michigan, United States
Arnold Markowitz, MD — Keego Harbor, Michigan, United States
Mercury Street Medical Group, LLC — Butte, Montana, United States
Dr. John Bernard — Belvidere, New Jersey, United States
University of Medicine & Dentistry of New Jersey, School of Osteopathic Medicine (UMDNJ-SOM) — Cherry Hill, New Jersey, United States
Warminster Medical Associates, P.C. — Warminster, Pennsylvania, United States
Ronald Collette, MD — Burnaby, British Columbia, Canada
The Medical Arts Health Research Group — Kelowna, British Columbia, Canada
Westview Research — North Vancouver, British Columbia, Canada
The Medical Arts Health Research Group — Penticton, British Columbia, Canada
Maritime Research Center — Bathurst, New Brunswick, Canada
Source Unique Research — Hawkesbury, Ontario, Canada
Gordon Schacter, MD — London, Ontario, Canada
London East Medical Centre — London, Ontario, Canada
SKDS Research Inc. — Newmarket, Ontario, Canada
University of Ottawa Health Services — Ottawa, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre — Sarnia, Ontario, Canada
Kings County Medical Centre — Montague, Prince Edward Island, Canada
Rhodin Recherche Clinique — Drummondville, Quebec, Canada
Centre Medical Acadie — Montreal, Quebec, Canada
Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky — Moscow, Russia
Moscow State Medico-Stomatological University — Moscow, Russia
State Healthcare Institution "City Clinical Hospital # 29" — Moscow, Russia

Full record on ClinicalTrials.gov

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