Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia

Sepsis Clinical Trial

— FINLEVO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548002
• Other study ID #: 210275
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2007
• Last updated: October 22, 2007
• Start date: January 1999
• Est. completion date: August 2002

Study information

• Verified date: October 2007
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia
• Endocarditis
• Sepsis
• Staphylococcus Aureus

Intervention

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

Locations

Country	Name	City	State
Finland	Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital	Helsinki	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Ruotsalainen E, Järvinen A, Koivula I, Kauma H, Rintala E, Lumio J, Kotilainen P, Vaara M, Nikoskelainen J, Valtonen V; Finlevo Study Group. Levofloxacin does not decrease mortality in Staphylococcus aureus bacteraemia when added to the standard treatment — View Citation

Ruotsalainen E, Sammalkorpi K, Laine J, Huotari K, Sarna S, Valtonen V, Järvinen A. Clinical manifestations and outcome in Staphylococcus aureus endocarditis among injection drug users and nonaddicts: a prospective study of 74 patients. BMC Infect Dis. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Case fatality rate		At 28 days and at 3 months
Secondary	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