Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia

University of Helsinki430 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

430

Conditions

Staphylococcus Aureus Bacteremia Endocarditis Sepsis

Interventions

trovafloxacin and levofloxacinDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital

Helsinki, HUS, Finland

Outcomes

Primary Outcomes

Case fatality rate

Time frame: At 28 days and at 3 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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