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Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108433
Recruitment Status : Terminated (See Detailed Description)
First Posted : April 18, 2005
Results First Posted : August 7, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bacteremia
Gram-Positive Bacterial Infections
Interventions Drug: Cefazolin IV
Drug: Linezolid IV
Drug: Vancomycin (IV)
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Linezolid Vancomycin/Cefazolin
Hide Arm/Group Description Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days. Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Period Title: Overall Study
Started 30 31
Completed 9 14
Not Completed 21 17
Reason Not Completed
Lack of Efficacy             1             2
Death             3             0
Adverse Event             3             1
Other             14             14
Arm/Group Title Linezolid Vancomycin/Cefazolin Total
Hide Arm/Group Description Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days. Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours. Total of all reporting groups
Overall Number of Baseline Participants 30 31 61
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 31 participants 61 participants
54.4  (17.7) 49.7  (15.4) 52.0  (16.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Female
13
  43.3%
13
  41.9%
26
  42.6%
Male
17
  56.7%
18
  58.1%
35
  57.4%
1.Primary Outcome
Title Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Hide Description 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.
Time Frame Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.
Arm/Group Title Linezolid Vancomycin/Cefazolin
Hide Arm/Group Description:
Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.
Arm/Group Title Linezolid Vancomycin/Cefazolin
Hide Arm/Group Description:
Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Complications During Therapy
Hide Description 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.
Time Frame LTFU visit (6 to 8 weeks after the last dose of study medication)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.
Arm/Group Title Linezolid Vancomycin/Cefazolin
Hide Arm/Group Description:
Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Pathogens Eradicated
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.
Arm/Group Title Linezolid Vancomycin/Cefazolin
Hide Arm/Group Description:
Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization
Hide Description Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.
Arm/Group Title Linezolid Vancomycin/Cefazolin
Hide Arm/Group Description:
Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Linezolid Vancomycin/Cefazolin
Hide Arm/Group Description Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days. Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
All-Cause Mortality
Linezolid Vancomycin/Cefazolin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Linezolid Vancomycin/Cefazolin
Affected / at Risk (%) Affected / at Risk (%)
Total   7/30 (23.33%)   3/31 (9.68%) 
Cardiac disorders     
Cardiopulmonary failure * 1  1/30 (3.33%)  0/31 (0.00%) 
Myocardial infarction * 1  1/30 (3.33%)  0/31 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  0/30 (0.00%)  1/31 (3.23%) 
Duodenal ulcer * 1  1/30 (3.33%)  0/31 (0.00%) 
Vomiting * 1  1/30 (3.33%)  0/31 (0.00%) 
General disorders     
Chills * 1  1/30 (3.33%)  0/31 (0.00%) 
Death * 1  0/30 (0.00%)  1/31 (3.23%) 
Pyrexia * 1  1/30 (3.33%)  1/31 (3.23%) 
Infections and infestations     
Bronchopneumonia * 1  1/30 (3.33%)  0/31 (0.00%) 
Endocarditis * 1  1/30 (3.33%)  0/31 (0.00%) 
Metabolism and nutrition disorders     
Fluid overload * 1  1/30 (3.33%)  0/31 (0.00%) 
Vascular disorders     
Hypertension * 1  0/30 (0.00%)  1/31 (3.23%) 
Hypertensive crisis * 1  1/30 (3.33%)  0/31 (0.00%) 
Hypotension * 1  1/30 (3.33%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Linezolid Vancomycin/Cefazolin
Affected / at Risk (%) Affected / at Risk (%)
Total   12/30 (40.00%)   9/31 (29.03%) 
Cardiac disorders     
Supraventricular tachycardia * 1  1/30 (3.33%)  0/31 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  1/30 (3.33%)  0/31 (0.00%) 
Dyspepsia * 1  1/30 (3.33%)  1/31 (3.23%) 
Gastric ulcer * 1  1/30 (3.33%)  0/31 (0.00%) 
Gastritis * 1  1/30 (3.33%)  0/31 (0.00%) 
Nausea * 1  2/30 (6.67%)  1/31 (3.23%) 
Oesophagitis * 1  1/30 (3.33%)  0/31 (0.00%) 
Vomiting * 1  6/30 (20.00%)  1/31 (3.23%) 
General disorders     
Asthenia * 1  0/30 (0.00%)  1/31 (3.23%) 
Pyrexia * 1  2/30 (6.67%)  3/31 (9.68%) 
Infections and infestations     
Candidiasis * 1  1/30 (3.33%)  0/31 (0.00%) 
Endocarditis * 1  0/30 (0.00%)  1/31 (3.23%) 
Psoas abscess * 1  0/30 (0.00%)  1/31 (3.23%) 
Sepsis * 1  1/30 (3.33%)  0/31 (0.00%) 
Viral infection * 1  0/30 (0.00%)  1/31 (3.23%) 
Investigations     
Aspartate aminotransferase increased * 1  0/30 (0.00%)  1/31 (3.23%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  0/30 (0.00%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/30 (0.00%)  1/31 (3.23%) 
Nervous system disorders     
Grand mal convulsion * 1  1/30 (3.33%)  0/31 (0.00%) 
Psychiatric disorders     
Agitation * 1  1/30 (3.33%)  0/31 (0.00%) 
Anxiety * 1  0/30 (0.00%)  1/31 (3.23%) 
Renal and urinary disorders     
Bladder outlet obstruction * 1  0/30 (0.00%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis * 1  1/30 (3.33%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  1/30 (3.33%)  0/31 (0.00%) 
Rash * 1  0/30 (0.00%)  1/31 (3.23%) 
Vascular disorders     
Hypotension * 1  1/30 (3.33%)  0/31 (0.00%) 
Jugular vein thrombosis * 1  0/30 (0.00%)  1/31 (3.23%) 
Subclavian vein thrombosis * 1  0/30 (0.00%)  1/31 (3.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Efficacy results were not reported because the study was prematurely terminated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00108433    
Other Study ID Numbers: A5951105
First Submitted: April 15, 2005
First Posted: April 18, 2005
Results First Submitted: June 28, 2012
Results First Posted: August 7, 2012
Last Update Posted: August 7, 2012