This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
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.
Time frame: Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)
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.
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
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)
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Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Barranquilla, Atlántico, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Bogotá, D.C, Colombia
Pfizer Investigational Site
Hyderbad, Andhra Pradesh, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
New Delhi, National Capital Territory of Delhi, India
...and 7 more locations
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.
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
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)