Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia (FINLEVO)

This study has been completed.
Information provided by:
Helsinki University Identifier:
First received: October 22, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard treatment, could reduce the high mortality and complication rates in Staphylococcus aureus bacteremia.

Condition Intervention Phase
Staphylococcus Aureus
Drug: trovafloxacin and levofloxacin
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Case fatality rate [ Time Frame: At 28 days and at 3 months ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 430
Study Start Date: January 1999
Study Completion Date: August 2002
Groups/Cohorts Assigned Interventions
1 and 2
Patients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin).
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population
Adult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00548002

Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital
Helsinki, HUS, Finland, 00029
Sponsors and Collaborators
Helsinki University
Principal Investigator: Eeva Ruotsalainen, MD Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00548002     History of Changes
Other Study ID Numbers: 210275 
Study First Received: October 22, 2007
Last Updated: October 22, 2007
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University:
Staphylococcus aureus

Additional relevant MeSH terms:
Bacterial Infections
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on May 25, 2016