Community-Acquired Pneumonia (CAP)Phase 2NCT00640926
Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia
A Phase 2 study testing Radezolid in people with Community-Acquired Pneumonia (CAP), run by Melinta Therapeutics, Inc. at 30 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Community-Acquired Pneumonia (CAP)
- What is being tested?
- Radezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 30 sitesin 3 countries
- Study dates
- Oct 2007to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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).
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
Canada14 sites
Maritime Research Center
Bathurst, New Brunswick
Ronald Collette, MD
Burnaby, British Columbia
Rhodin Recherche Clinique
Drummondville, Quebec
Source Unique Research
Hawkesbury, Ontario
The Medical Arts Health Research Group
Kelowna, British Columbia
Gordon Schacter, MD
London, Ontario
London East Medical Centre
London, Ontario
Kings County Medical Centre
Montague, Prince Edward Island
Centre Medical Acadie
Montreal, Quebec
SKDS Research Inc.
Newmarket, Ontario
Westview Research
North Vancouver, British Columbia
University of Ottawa Health Services
Ottawa, Ontario
The Medical Arts Health Research Group
Penticton, British Columbia
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario
United States8 sites
Dr. John Bernard
Belvidere, New Jersey
Mercury Street Medical Group, LLC
Butte, Montana
University of Medicine & Dentistry of New Jersey, School of Osteopathic Medicine (UMDNJ-SOM)
Cherry Hill, New Jersey
Wayne State University School of Medicine/Detroit Receiving Hospital
Detroit, Michigan
Arnold Markowitz, MD
Keego Harbor, Michigan
eStudySite
San Diego, California
Olive View- UCLA Center, Dept. Emergency Medicine
Sylmar, California
Warminster Medical Associates, P.C.
Warminster, Pennsylvania
Russia8 sites
Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
Moscow
Moscow State Medico-Stomatological University
Moscow
State Healthcare Institution "City Clinical Hospital # 29"
Moscow
State Healthcare Institution Moscow
Moscow
City Hospital # 31
Saint Petersburg
St. Petersburg City Hospital # 26
Saint Petersburg
St. Petersburg Pavlov State Medical University
Saint Petersburg
St. Petersburg Scientific-Research Institute of Pulmonology at State Medical University named after Academician I.P. Pavlov
Saint Petersburg
About this study
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)
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)
- Being tested
- Radezolid
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadezolidDrug
Also called RX-1741
300 mg/day, orally for 7-10 days
RadezolidDrug
Also called RX-1741
450 mg/day orally for 7-10 days
RadezolidDrug
Also called RX-1741
900 mg/day orally for 7-10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Radezolid 300 mg Receives: Drug: Radezolid |
| 2 | Experimental | Radezolid 450 mg Receives: Drug: Radezolid |
| 3 | Experimental | Radezolid 450 mg BID Receives: Drug: Radezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study days 14-38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Community-Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640926
- Sponsor's protocol ID
- RX-1741-201
- Status last verified
- Apr 2016
- First submitted
- 18 Mar 2008
- Last updated
- 12 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00640926
- Acronym / sponsor ID
- RX-1741-201
- Conditions
- Community-Acquired Pneumonia (CAP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Posted 4 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RadezolidRadezolid 300 mg |
| 2 | Experimental | Drug: RadezolidRadezolid 450 mg |
| 3 | Experimental | Drug: RadezolidRadezolid 450 mg BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadezolidAlso: RX-1741300 mg/day, orally for 7-10 days | Drug | 1 |
| RadezolidAlso: RX-1741450 mg/day orally for 7-10 days | Drug | 2 |
| RadezolidAlso: RX-1741900 mg/day orally for 7-10 days | Drug | 3 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Community-Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
RecruitingPhase 3
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radezolid in people with Community-Acquired Pneumonia (CAP), run by Melinta Therapeutics, Inc. at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Canada, United States, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC) (time frame: Study days 14-38). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.