Pneumonia, PneumococcalPhase 3NCT00035269
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
A Phase 3 study testing Antibiotic in people with Pneumonia, Pneumococcal and Community Acquired Infections, run by Pfizer at 46 sites in 4 countries.
Trial summary
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae) Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pneumonia, Pneumococcal, Community Acquired Infections, Gram-positive Bacterial Infections
- What is being tested?
- Antibiotic
- How many people
- 230 participants
- Where
- 46 sitesin 4 countries
- Study dates
- Dec 2001to May 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia.
- The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment.
Who cannot join
- Patients cannot have taken more than one day of another antibiotic before entering this study.
- Patients with HIV and a low CD4 count are excluded.
Trial locations and contacts
46 sites in 4 countries.
46 sites in 4 countries
United States34 sites
Research Center
Ann Arbor, Michigan, 48197
Research Center
Baltimore, Maryland, 21201
Research Center
Baton Rouge, Louisiana, 70808
Research Center
Charlottesville, Virginia, 22902
Research Center
Columbus, Ohio, 43215
Research Center
Dallas, Texas, 75235
Research Center
Fleetwood, Pennsylvania, 19522
Research Center
Hackensack, New Jersey, 07601
Research Center
Harrogate, Tennessee, 37752-0078
Research Center
Hershey, Pennsylvania, 17033
Research Center
Houston, Texas, 77030
Research Center
Jackson, Tennessee, 38301
Research Center
Jacksonville, Florida, 32209
Research Center
Knoxville, Tennessee, 37920
Research Center
Los Angeles, California, 90033
Research Center
Lubbock, Texas, 79430
Research Center
Memphis, Tennessee, 38104-3499
Research Center
Memphis, Tennessee, 38120
Research Center
Memphis, Tennessee, 38163
Research Center
Naples, Florida, 34102
Research Center
Nashville, Tennessee, 37205
Research Center
Newark, New Jersey, 07102
Research Center
Ninety Six, South Carolina, 29666
Research Center
Richmond, Virginia, 23294
Research Center
Royal Oak, Michigan, 48073
Research Center
Savannah, Georgia, 31416
Research Center
Seattle, Washington, 98108
Research Center
Somerville, New Jersey, 08876
Research Center
Spartanburg, South Carolina, 29307
Research Center
Springfield, Illinois, 62701
Research Center
Springfield, Missouri, 65807
Research Center
Staten Island, New York, 10305
Research Center
Stony Brook, New York, 11794
Research Center
Zanesville, Ohio, 43701
Spain9 sites
Research Center
Barcelona, Barcelona, 08025
Research Center
Barcelona, Barcelona, 08036
Research Center
Barcelona, Barcelona, 08907
Research Center
Girona, Girona, 17007
Research Center
Madrid, Madrid, 28034
Research Center
Madrid, Madrid, 28046
Research Center
Madrid, Madrid, 28923
Research Center
Mataró, Barcelona, 08304
Research Center
Móstoles, Madrid, 28935
About this study
Official title: Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
- Conditions
- Pneumonia, Pneumococcal, Community Acquired Infections, Gram-positive Bacterial Infections
- Being tested
- Antibiotic
- Keywords
- Pharmacia
- Medical subject headings
- Pneumonia, Pneumococcal, Community-Acquired Infections, Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.
Secondary outcomes (1)
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startDec 2001
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, PneumococcalStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035269
- Sponsor's protocol ID
- M12600071
- Other IDs
- A5951056
- Status last verified
- Apr 2011
- First submitted
- 2 May 2002
- Last updated
- 26 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study
- ClinicalTrials.gov ID
- NCT00035269
- Acronym / sponsor ID
- M12600071
- Conditions
- Pneumonia, Pneumococcal, Community Acquired Infections, Gram-positive Bacterial Infections
- Keywords
- Pharmacia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- May 2003 (actual)
- First posted
- 3 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia.
- The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment.
Key exclusion criteria (2 listed)
- Patients cannot have taken more than one day of another antibiotic before entering this study.
- Patients with HIV and a low CD4 count are excluded.
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 |
|---|---|---|
| Antibiotic | Drug | – |
Primary outcome
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.
1 secondary outcome
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
Related trials for Pneumonia, Pneumococcal
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
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.
46 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antibiotic in people with Pneumonia, Pneumococcal and Community Acquired Infections, run by Pfizer at 46 sites in 4 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 2 inclusion and 2 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 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Spain, Taiwan, Slovakia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).. The study lists 2 primary outcomes in all. 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 26 Apr 2011.