NCT00640926

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
3 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 4, 2010

Completed
Last Updated

May 12, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

March 18, 2008

Results QC Date

January 8, 2010

Last Update Submit

April 7, 2016

Conditions

Community-Acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (1)

  • Per Patient Microbiological Response of Eradicated in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)

    Study Days 14-38

Study Arms (3)

1

EXPERIMENTAL

Radezolid 300 mg

Drug: Radezolid

2

EXPERIMENTAL

Radezolid 450 mg

Drug: Radezolid

3

EXPERIMENTAL

Radezolid 450 mg BID

Drug: Radezolid

Interventions

RadezolidDRUG

300 mg/day, orally for 7-10 days

Also known as: RX-1741
1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

eStudySite

San Diego, California, United States

Location

Olive View- UCLA Center, Dept. Emergency Medicine

Sylmar, California, United States

Location

Wayne State University School of Medicine/Detroit Receiving Hospital

Detroit, Michigan, United States

Location

Arnold Markowitz, MD

Keego Harbor, Michigan, United States

Location

Mercury Street Medical Group, LLC

Butte, Montana, United States

Location

Dr. John Bernard

Belvidere, New Jersey, United States

Location

University of Medicine & Dentistry of New Jersey, School of Osteopathic Medicine (UMDNJ-SOM)

Cherry Hill, New Jersey, United States

Location

Warminster Medical Associates, P.C.

Warminster, Pennsylvania, United States

Location

Ronald Collette, MD

Burnaby, British Columbia, Canada

Location

The Medical Arts Health Research Group

Kelowna, British Columbia, Canada

Location

Westview Research

North Vancouver, British Columbia, Canada

Location

The Medical Arts Health Research Group

Penticton, British Columbia, Canada

Location

Maritime Research Center

Bathurst, New Brunswick, Canada

Location

Source Unique Research

Hawkesbury, Ontario, Canada

Location

Gordon Schacter, MD

London, Ontario, Canada

Location

London East Medical Centre

London, Ontario, Canada

Location

SKDS Research Inc.

Newmarket, Ontario, Canada

Location

University of Ottawa Health Services

Ottawa, Ontario, Canada

Location

London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Location

Kings County Medical Centre

Montague, Prince Edward Island, Canada

Location

Rhodin Recherche Clinique

Drummondville, Quebec, Canada

Location

Centre Medical Acadie

Montreal, Quebec, Canada

Location

Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

Moscow, Russia

Location

Moscow State Medico-Stomatological University

Moscow, Russia

Location

State Healthcare Institution "City Clinical Hospital # 29"

Moscow, Russia

Location

State Healthcare Institution Moscow

Moscow, Russia

Location

City Hospital # 31

Saint Petersburg, Russia

Location

St. Petersburg City Hospital # 26

Saint Petersburg, Russia

Location

St. Petersburg Pavlov State Medical University

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

radezolid

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Limitations and Caveats

The yield of typical bacterial pathogens, most importantly S. pneumoniae, was quite low. The presence of atypical pathogens was assessed only by paired serologies, not by culture or polymerase chain reaction (PCR).

Results Point of Contact

Title
Sue Cammarata, MD
Organization
Melinta Therapeutics, Inc.
scammarata@melinta.com
(203) 624-5606

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 21, 2008

Study Start

October 1, 2007

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

May 12, 2016

Results First Posted

February 4, 2010

Record last verified: 2016-04

Locations

RU(8)US(8)CA(14)