Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia (FINLEVO)

This study has been completed.
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00548002
First received: October 22, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

October 22, 2007
October 22, 2007
January 1999
Not Provided
Case fatality rate [ Time Frame: At 28 days and at 3 months ]
Same as current
No Changes Posted
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. [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia
Not Provided

To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard treatment, could reduce the high mortality and complication rates in Staphylococcus aureus bacteremia.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Not Provided

Adult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling.

  • Staphylococcus Aureus
  • Bacteremia
  • Endocarditis
  • Sepsis
Drug: trovafloxacin and levofloxacin
Trovafloxacin: <60 kg 200 mg iv/orally once daily and >60 kg 300 mg iv/orally once daily Levofloxacin: < 60 kg 500 mg iv/orally once daily and >60 kg 500 mg iv/orally bid
1 and 2
Patients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin).
Intervention: Drug: trovafloxacin and levofloxacin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
August 2002
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00548002
210275
No
Not Provided
Helsinki University
Not Provided
Principal Investigator: Eeva Ruotsalainen, MD Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland
Helsinki University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP