Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00640926
First received: March 18, 2008
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

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 (Subject, 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640926

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

No publications provided

Responsible Party: Scott Hopkins, MD, Rib-X Pharmaceuticals, Inc.
ClinicalTrials.gov 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: February 11, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Radezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014