Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia

Completed

• Conditions: Staphylococcus Aureus; Sepsis; Endocarditis; Bacteremia
• Interventions: Drug: trovafloxacin and levofloxacin

• Registration Number: NCT00548002
• Lead Sponsor: University of Helsinki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Study Completion: 2002-08
• Status Verified: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Last Update Submitted: 2007-10-22
• Study First Posted: 2007-10-23
• Last Update Posted: 2007-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 and 2	trovafloxacin and levofloxacin	Patients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin).

Primary Outcome Measures

Name	Time	Method
Case fatality rate	At 28 days and at 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital; 🇫🇮 Helsinki, HUS, Finland