Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia
Information source: Helsinki University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Staphylococcus Aureus; Bacteremia; Endocarditis; Sepsis
Intervention: trovafloxacin and levofloxacin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Helsinki University Official(s) and/or principal investigator(s):
Eeva Ruotsalainen, MD, Principal Investigator, Affiliation: Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland
Summary
To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard
treatment, could reduce the high mortality and complication rates in Staphylococcus aureus
bacteremia.
Clinical Details
Study design: Cohort, Prospective
Primary outcome: Case fatality rate
Secondary outcome: The number of complications (e.g. deep infections) observed after the first week antibiotic treatment, decrease in serum C-reactive protein concentration, length of antibiotic treatment, need for surgical intervention, and time to defervescence.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Adult patients with at least 1 blood culture positive for Staphylococcus aureus were
included within 1 to 7 days of blood culture sampling.
Exclusion Criteria:
- age younger than 18 years
- imprisonment
- proven or suspected pregnancy
- breastfeeding, epilepsy
- another bacteremia during the previous 28 days
- polymicrobial bacteremia (_>3 microbes)
- history of allergy to any quinolone antibiotic
- previous tendinitis during fluoroquinolone therapy
- prior fluoroquinolone use for more than 5 days before randomization
- positive culture for Staphylococcus aureus only from a central intravenous catheter
- neutropenia (<0. 5 x 109/L) or failure to supply an informed consent
- patients with bacteremia due to methicillin-resistant S. aureus and a S. aureus strain
resistant to any fluoroquinolone
- patients with meningitis at the time of randomization
Locations and Contacts
Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, HUS 00029, Finland
Additional Information
Starting date: January 1999
Ending date: August 2002
Last updated: October 22, 2007
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