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
  Purpose

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
Bacteremia
Endocarditis
Sepsis
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

  Eligibility

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548002

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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
bacteremia
endocarditis
sepsis
fluoroquinolone
rifampin
levofloxacin
trovafloxacin

Additional relevant MeSH terms:
Bacteremia
Endocarditis
Sepsis
Bacterial Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Levofloxacin
Ofloxacin
Fluoroquinolones
Trovafloxacin
Alatrofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014