Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00548002

Acronym

FINLEVO

Enrollment

430

Registered

2007-10-23

Start date

1999-01-31

Completion date

2002-08-31

Last updated

2007-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Endocarditis, Sepsis, Staphylococcus Aureus

Keywords

Staphylococcus aureus, bacteremia, endocarditis, sepsis, fluoroquinolone, rifampin, levofloxacin, trovafloxacin

Brief summary

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

Interventions

DRUGtrovafloxacin 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Case fatality rate	At 28 days and at 3 months

Secondary

Measure	Time frame
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.	3 months

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026