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Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia

This study has been completed.
Information provided by (Responsible Party):
Melinta Therapeutics, Inc. Identifier:
First received: March 18, 2008
Last updated: April 7, 2016
Last verified: April 2016
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).

Condition Intervention Phase
Community-Acquired Pneumonia (CAP)
Drug: Radezolid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Melinta Therapeutics, Inc.:

Primary Outcome Measures:
  • Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC) [ Time Frame: Study days 14-38 ]
    Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.

Other Outcome Measures:
  • Per Patient Microbiological Response of Eradicated in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC) [ Time Frame: Study Days 14-38 ]
    The number of ME patients (defined as those CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila) with a microbiologic response of eradicated, i.e. either documented eradication of the baseline pathogen(s), or presumed eradication in the setting of clinical cure with no material to culture.

Enrollment: 158
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
Experimental: 1
Radezolid 300 mg
Drug: Radezolid
300 mg/day, orally for 7-10 days
Other Name: RX-1741
Experimental: 2
Radezolid 450 mg
Drug: Radezolid
450 mg/day orally for 7-10 days
Other Name: RX-1741
Experimental: 3
Radezolid 450 mg BID
Drug: Radezolid
900 mg/day orally for 7-10 days
Other Name: RX-1741


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00640926

  Show 30 Study Locations
Sponsors and Collaborators
Melinta Therapeutics, Inc.
  More Information

Responsible Party: Melinta Therapeutics, Inc. Identifier: NCT00640926     History of Changes
Other Study ID Numbers: RX-1741-201
Study First Received: March 18, 2008
Results First Received: January 8, 2010
Last Updated: April 7, 2016

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017