BacteremiaPhase 3NCT00108433
Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
A Phase 3 study testing Cefazolin IV, Linezolid IV and Vancomycin (IV) in people with Bacteremia and Gram-Positive Bacterial Infections, run by Pfizer at 17 sites in 7 countries.
Trial summary
This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia, Gram-Positive Bacterial Infections
- What is being tested?
- Cefazolin IV, Linezolid IV and Vancomycin (IV)
- Type of treatment
- Injection or infusion
- How many people
- 61 participants
- Where
- 17 sitesin 7 countries
- Study dates
- Sep 2005to Sep 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for this study, a patient must provide informed consent and must meet all of the following criteria. No study procedures, including any baseline tests, should be performed until the patient (or parent/legally acceptable representative, if appropriate) legally signs the informed consent form.
- Male or female, 18 years of age or older and >= 40 kg body weight
- End-stage renal disease patients on hemodialysis with: A) Signs and symptoms of a localized catheter-related infection (eg tenderness and/or pain, erythema, swelling, purulent exudates within 2 cm of entry site); OR B) A body temperature of >= 38.0 C or < 36.0 C (oral equivalent); OR C) A Gram-positive blood culture. If the Gram-positive isolate is S. aureus, it must be cultured from at least 1 culture bottle from either the peripheral set or the catheter set of culture bottles. For all other Gram-positive pathogens (eg, coagulase-negative staphylococci), isolates need to be cultured from at least 2 culture bottles of which one must be from the peripheral set. There must be no other obvious source of the bacteremia
- Presence of at least one of the following systemic signs of infection (may be obtained up to 24 hours prior to baseline): *Hypotension, defined as systolic blood pressure <90 mmHg or its reduction by >= 40 mmHg from the patient's baseline, in the absence of other causes for hypotension; *Tachycardia defined as a pulse rate > 90 beats per minute; *Tachypnea defined as a respiratory rate > 20 breaths per minute or PACO2 <32 torr; *White blood count >10,000 cells/mm3 or < 4,000 cells/mm3, or with a differential count showing >10% band neutrophil forms.
- Patients on hemodialysis with tunneled or nontunneled catheters including antibiotic coated hemodialysis catheters. Patients may have more than one concurrent catheter.
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Who cannot join
- Patients presenting with any of the following will not be included in this study:
- Catheter-related bloodstream infections caused by Gram-negative bacteria, fungi, mixed cultures of Gram negative bacteria and Gram positive bacteria or mixed cultures of Gram positive/negative bacteria and fungi
- Patients with evidence of other infections resulting in bacteremia, such as clinical or radiographic signs of osteomyelitis, endocarditis, skin/skin structure infection, pneumonia, urinary tract infection, joint infection, intraabdominal infection, septic thrombophlebitis or other infection
- Patients in whom the infected catheter cannot be removed
- Patients with permanent intravascular devices such as artificial vascular grafts, implantable pacemakers or defibrillators; intra-aortic balloon pumps, and left ventricular assist device; intravascular transplants such as prosthetic cardiac valves; or non-intravascular devices such as peritoneal dialysis catheters; or neurosurgical devices such as ventriculo-peritoneal shunts, intra-cranial pressure monitors, or epidural catheters, prosthetic cardiac valves, prosthetic vascular grafts, or other internal prosthesis
- Females of child-bearing potential who are unable or unwilling to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant
Show all 13Show fewer
- Identification of a pathogen resistant to linezolid or vancomycin
- Patients who are unlikely to survive through the treatment period and evaluation
- Administration of a glycopeptide antibiotic within 5 days prior to enrollment. Administration of other potentially effective systemic Gram-positive antibiotics for more than 48 hours within 72 hours prior to enrollment unless the pathogen showed drug resistance
- Previous enrollment in this protocol
- Hypersensitivity to linezolid, vancomycin, gentamicin or one of their excipients (or aztreonam if non-bacteremic Gram-negative coverage is required)
- Concurrent use of another investigational medication or use within 30 days of study entry
- Patients with pressor and fluid-resistant hemodynamic compromise or pulmonary embolism
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
India6 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Bangalore, Karnataka, 560 054
Pfizer Investigational Site
Chandigarh, Punjab, 160 012
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 004
Pfizer Investigational Site
Hyderbad, Andhra Pradesh, 500 082
Pfizer Investigational Site
New Delhi, National Capital Territory of Delhi, 110 044
United States3 sites
Pfizer Investigational Site
Baltimore, Maryland, 21201-1524
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Baltimore, Maryland, 21230
Colombia3 sites
Pfizer Investigational Site
Barranquilla, Atlántico
Pfizer Investigational Site
Bogota, Cundinamarca, 0
Pfizer Investigational Site
Bogotá, D.C
Slovakia2 sites
Pfizer Investigational Site
Banská Bystrica, Slovakia, 975 17
Pfizer Investigational Site
Nitra, 950 01
About this study
Official title: Linezolid vs Vancomycin/Cefazolin in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
Read the detailed description
Pfizer suspended enrollment on 21 August 2006 as a precautionary measure in light of the mortality imbalance seen in a similar study, and terminated the study on April 6, 2007 due to factors affecting the timeline to completion, such as slow enrollment and inclusion of sufficient evaluable subjects.
- Conditions
- Bacteremia, Gram-Positive Bacterial Infections
- Being tested
- Cefazolin IV, Linezolid IV, Vancomycin (IV)
- Medical subject headings
- Bacteremia, Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin IVDrug
Linezolid IVDrug
Vancomycin (IV)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.
Measured: Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)
Secondary outcomes (4)
Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment
Ir assessment Cure: clinical signs/symptoms of infection (SSx) resolved and no reoccurrence; Improvement: Moderate resolution of SSx, no additional antibiotic needed; Failure: persistence/progression of baseline SSx, new clinical findings; Indeterminate: circumstances precluding above classification. Sp assessment Failure: concomitant antibiotic after day 3 up to/including Ir assessment day at TOC/upper limit of TOC window (if no Ir assessment at TOC), no Ir assessment at end of treatment (EOT) and TOC; Indeterminate: Sp assessment cured/ improved at EOT, no Ir assessment at TOC/indeterminate.
Measured: EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)
Number of Participants With Complications During Therapy
Late metastatic sequelae associated with Gram positive bacterial infections: abdominal abscess, brain abscess, meningitis, septic arthritis, osteomyelitis, endocarditis, empyema, spinal epidural abscess, intracerebral epidural abscess, septic phlebitis and septic thrombophlebitis.
Measured: LTFU visit (6 to 8 weeks after the last dose of study medication)
Percentage of Pathogens Eradicated
Eradication included Documented or Presumed Eradication of the given pathogen. Percentage of pathogen eradicated was calculated as number of pathogens eradicated divided by number of pathogens eradicated or persisted multiplied by 100.
Measured: STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)
Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization
Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.
Measured: STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2005 (estimated)
- Study startSep 2005
- Study completionSep 2006
Why it stopped: See Detailed Description
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108433
- Sponsor's protocol ID
- A5951105
- Status last verified
- Jun 2012
- First submitted
- 15 Apr 2005
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
PubMed 35363884
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linezolid vs Vancomycin/Cefazolin in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
- ClinicalTrials.gov ID
- NCT00108433
- Acronym / sponsor ID
- A5951105
- Conditions
- Bacteremia, Gram-Positive Bacterial Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description
- Enrolment
- 61 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 18 Apr 2005 (estimated)
- Results
- Posted 7 Aug 2012
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 hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
Detailed description
Pfizer suspended enrollment on 21 August 2006 as a precautionary measure in light of the mortality imbalance seen in a similar study, and terminated the study on April 6, 2007 due to factors affecting the timeline to completion, such as slow enrollment and inclusion of sufficient evaluable subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be eligible for this study, a patient must provide informed consent and must meet all of the following criteria. No study procedures, including any baseline tests, should be performed until the patient (or parent/legally acceptable representative, if appropriate) legally signs the informed consent form.
- Male or female, 18 years of age or older and >= 40 kg body weight
- End-stage renal disease patients on hemodialysis with: A) Signs and symptoms of a localized catheter-related infection (eg tenderness and/or pain, erythema, swelling, purulent exudates within 2 cm of entry site); OR B) A body temperature of >= 38.0 C or < 36.0 C (oral equivalent); OR C) A Gram-positive blood culture. If the Gram-positive isolate is S. aureus, it must be cultured from at least 1 culture bottle from either the peripheral set or the catheter set of culture bottles. For all other Gram-positive pathogens (eg, coagulase-negative staphylococci), isolates need to be cultured from at least 2 culture bottles of which one must be from the peripheral set. There must be no other obvious source of the bacteremia
- Presence of at least one of the following systemic signs of infection (may be obtained up to 24 hours prior to baseline): *Hypotension, defined as systolic blood pressure <90 mmHg or its reduction by >= 40 mmHg from the patient's baseline, in the absence of other causes for hypotension; *Tachycardia defined as a pulse rate > 90 beats per minute; *Tachypnea defined as a respiratory rate > 20 breaths per minute or PACO2 <32 torr; *White blood count >10,000 cells/mm3 or < 4,000 cells/mm3, or with a differential count showing >10% band neutrophil forms.
- Patients on hemodialysis with tunneled or nontunneled catheters including antibiotic coated hemodialysis catheters. Patients may have more than one concurrent catheter.
Key exclusion criteria (13 listed)
- Patients presenting with any of the following will not be included in this study:
- Catheter-related bloodstream infections caused by Gram-negative bacteria, fungi, mixed cultures of Gram negative bacteria and Gram positive bacteria or mixed cultures of Gram positive/negative bacteria and fungi
- Patients with evidence of other infections resulting in bacteremia, such as clinical or radiographic signs of osteomyelitis, endocarditis, skin/skin structure infection, pneumonia, urinary tract infection, joint infection, intraabdominal infection, septic thrombophlebitis or other infection
- Patients in whom the infected catheter cannot be removed
- Patients with permanent intravascular devices such as artificial vascular grafts, implantable pacemakers or defibrillators; intra-aortic balloon pumps, and left ventricular assist device; intravascular transplants such as prosthetic cardiac valves; or non-intravascular devices such as peritoneal dialysis catheters; or neurosurgical devices such as ventriculo-peritoneal shunts, intra-cranial pressure monitors, or epidural catheters, prosthetic cardiac valves, prosthetic vascular grafts, or other internal prosthesis
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 |
|---|---|---|
| Cefazolin IV | Drug | – |
| Linezolid IV | Drug | – |
| Vancomycin (IV) | Drug | – |
Primary outcome
Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Time frame: Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)
Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.
4 secondary outcomes
Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment
Time frame: EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)
Number of Participants With Complications During Therapy
Time frame: LTFU visit (6 to 8 weeks after the last dose of study medication)
Percentage of Pathogens Eradicated
Time frame: STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)
Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization
Time frame: STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35363884Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefazolin IV, Linezolid IV and Vancomycin (IV) in people with Bacteremia and Gram-Positive Bacterial Infections, run by Pfizer at 17 sites in 7 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in India, United States, Colombia, Slovakia, Israel and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2012). 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?
Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit (time frame: Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00108433, which also lists 1 linked publication.
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 7 Aug 2012.