Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia

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

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Key information

Conditions

Staphylococcus Aureus Bacteremia Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Endocarditis Gram-Positive Bacterial Infections Heart Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Staphylococcal Infections Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Helsinki, HUS, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trovafloxacin and levofloxacin

Drug

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

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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Acronym: FINLEVO

Important dates

Study start: 1999
Study completion: 2002
First posted: Oct 23, 2007
Registry last updated: Oct 23, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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