Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia

Community-Acquired Pneumonia (CAP) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640926
• Other study ID #: RX-1741-201
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2008
• Last updated: January 16, 2015
• Start date: October 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2010
• Source: Melinta Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-Acquired Pneumonia (CAP)
• Pneumonia

Intervention

Drug:
• Radezolid
300 mg/day, orally for 7-10 days
• Radezolid
450 mg/day orally for 7-10 days
• Radezolid
900 mg/day orally for 7-10 days

Locations

Country	Name	City	State
Canada	Maritime Research Center	Bathurst	New Brunswick
Canada	Ronald Collette, MD	Burnaby	British Columbia
Canada	Rhodin Recherche Clinique	Drummondville	Quebec
Canada	Source Unique Research	Hawkesbury	Ontario
Canada	The Medical Arts Health Research Group	Kelowna	British Columbia
Canada	Gordon Schacter, MD	London	Ontario
Canada	London East Medical Centre	London	Ontario
Canada	Kings County Medical Centre	Montague	Prince Edward Island
Canada	Centre Medical Acadie	Montreal	Quebec
Canada	SKDS Research Inc.	Newmarket	Ontario
Canada	Westview Research	North Vancouver	British Columbia
Canada	University of Ottawa Health Services	Ottawa	Ontario
Canada	The Medical Arts Health Research Group	Penticton	British Columbia
Canada	London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario
Russian Federation	Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky	Moscow
Russian Federation	Moscow State Medico-Stomatological University	Moscow
Russian Federation	State Healthcare Institution "City Clinical Hospital # 29"	Moscow
Russian Federation	State Healthcare Institution Moscow	Moscow
Russian Federation	City Hospital # 31	St. Petersburg
Russian Federation	St. Petersburg City Hospital # 26	St. Petersburg
Russian Federation	St. Petersburg Pavlov State Medical University	St. Petersburg
Russian Federation	St. Petersburg Scientific-Research Institute of Pulmonology at State Medical University named after Academician I.P. Pavlov	St. Petersburg
United States	Dr. John Bernard	Belvidere	New Jersey
United States	Mercury Street Medical Group, LLC	Butte	Montana
United States	University of Medicine & Dentistry of New Jersey, School of Osteopathic Medicine (UMDNJ-SOM)	Cherry Hill	New Jersey
United States	Wayne State University School of Medicine/Detroit Receiving Hospital	Detroit	Michigan
United States	Arnold Markowitz, MD	Keego Harbor	Michigan
United States	eStudySite	San Diego	California
United States	Olive View- UCLA Center, Dept. Emergency Medicine	Sylmar	California
United States	Warminster Medical Associates, P.C.	Warminster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Melinta Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Per Patient Microbiological Response of Eradicated in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)	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.	Study Days 14-38	No
Primary	Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)	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.	Study days 14-38	No