Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia

NCT ID: NCT00640926

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-04-30

Brief Summary

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).

Conditions

Community-Acquired Pneumonia (CAP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Radezolid 300 mg

Group Type: EXPERIMENTAL

Radezolid

Intervention Type: DRUG

300 mg/day, orally for 7-10 days

2

Radezolid 450 mg

Group Type: EXPERIMENTAL

Radezolid

Intervention Type: DRUG

450 mg/day orally for 7-10 days

3

Radezolid 450 mg BID

Group Type: EXPERIMENTAL

Radezolid

Intervention Type: DRUG

900 mg/day orally for 7-10 days

Interventions

Radezolid

300 mg/day, orally for 7-10 days

Intervention Type: DRUG

Radezolid

450 mg/day orally for 7-10 days

Intervention Type: DRUG

Radezolid

900 mg/day orally for 7-10 days

Intervention Type: DRUG

Other Intervention Names

RX-1741; RX-1741; RX-1741

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

State Healthcare Institution Moscow

Moscow, , Russia

City Hospital # 31

Saint Petersburg, , Russia

St. Petersburg City Hospital # 26

Saint Petersburg, , Russia

St. Petersburg Pavlov State Medical University

Saint Petersburg, , Russia

St. Petersburg Scientific-Research Institute of Pulmonology at State Medical University named after Academician I.P. Pavlov

Saint Petersburg, , Russia

Countries

United States; Canada; Russia

Other Identifiers

RX-1741-201

Identifier Type: -

Identifier Source: org_study_id