Bacterial InfectionsPhase 3NCT00035854
New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
A Phase 3 study testing Zyvox® / Linezolid in people with Bacterial Infections, run by Pfizer at 21 sites in United States.
Trial summary
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus) Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Zyvox® / Linezolid
- How many people
- 13 participants
- Where
- 21 sitesUnited States
- Study dates
- Feb 2002to May 2004
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized/chronic care pediatric patients (birth through 17 years)
- Known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections
- Requires a minimum of 3 days of IV medication
- Patients with mixed infections due to VRE \& gram negative bacteria are allowed to enroll in the study. For most of the infections, 2 or more of additional symptoms are required.
Who cannot join
- Potentially effective concomitant antibiotic
- A high surgical cure rate
- Medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days
- 24 hours of antibiotic treatment within 48 hours of study entry (unless pre-approved)
- Having an infected device that could not be removed
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Research Center
Atlanta, Georgia, 30342
Research Center
Austin, Texas, 78701
Research Center
Baltimore, Maryland, 21287
Research Center
Boston, Massachusetts, 02111
Research Center
Camden, New Jersey, 08103
Research Center
Chicago, Illinois, 60614
Research Center
Cleveland, Ohio, 44195
Research Center
Danville, Pennsylvania, 17822
Research Center
Detroit, Michigan, 48201
Research Center
Gainesville, Florida, 32610
Research Center
Hartford, Connecticut, 06106
Research Center
Long Beach, California, 90806
Research Center
Los Angeles, California, 90027
Research Center
Los Angeles, California, 90095
Research Center
Louisville, Kentucky, 40202
Research Center
New York, New York, 10021
Research Center
New York, New York, 10029
Research Center
New York, New York, 10032
Research Center
Park Ridge, Illinois, 60068
Research Center
Philadelphia, Pennsylvania, 19104
Research Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
- Conditions
- Bacterial Infections
- Being tested
- Zyvox® / Linezolid
- Keywords
- Pharmacia, Drug Resistance, Microbial
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zyvox® / LinezolidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's and sponsor's evaluation of patient clinical outcome.
Secondary outcomes (1)
Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2002 (estimated)
- Study startFeb 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035854
- Sponsor's protocol ID
- M12600082VRE
- Other IDs
- A5951062
- Status last verified
- Aug 2009
- First submitted
- 6 May 2002
- Last updated
- 14 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children
- ClinicalTrials.gov ID
- NCT00035854
- Acronym / sponsor ID
- M12600082VRE
- Conditions
- Bacterial Infections
- Keywords
- Pharmacia, Drug Resistance, Microbial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Study completion
- May 2004 (actual)
- First posted
- 7 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 pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Hospitalized/chronic care pediatric patients (birth through 17 years)
- Known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections
- Requires a minimum of 3 days of IV medication
- Patients with mixed infections due to VRE \& gram negative bacteria are allowed to enroll in the study. For most of the infections, 2 or more of additional symptoms are required.
Key exclusion criteria (5 listed)
- Potentially effective concomitant antibiotic
- A high surgical cure rate
- Medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days
- 24 hours of antibiotic treatment within 48 hours of study entry (unless pre-approved)
- Having an infected device that could not be removed
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 |
|---|---|---|
| Zyvox® / Linezolid | Drug | – |
Primary outcome
Investigator's and sponsor's evaluation of patient clinical outcome.
1 secondary outcome
Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
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 14 Aug 2009.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zyvox® / Linezolid in people with Bacterial Infections, run by Pfizer at 21 sites in United States.
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 4 inclusion and 5 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 14 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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?
Investigator's and sponsor's evaluation of patient clinical outcome.. 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 14 Aug 2009.