Clinical trial NCT00548002: Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus
Bacteremia
Endocarditis
Sepsis
Keywords: Staphylococcus aureus
bacteremia
endocarditis
sepsis
fluoroquinolone
rifampin
levofloxacin
trovafloxacin
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Study population: Adult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Case fatality rate
timeFrame: At 28 days and at 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital
state: HUS
Study officials:
affiliation: Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland
name: Eeva Ruotsalainen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruotsalainen E, Jarvinen 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: a prospective and randomized clinical trial of 381 patients. J Intern Med. 2006 Feb;259(2):179-90. doi: 10.1111/j.1365-2796.2005.01598.x.
citation: Ruotsalainen E, Sammalkorpi K, Laine J, Huotari K, Sarna S, Valtonen V, Jarvinen A. Clinical manifestations and outcome in Staphylococcus aureus endocarditis among injection drug users and nonaddicts: a prospective study of 74 patients. BMC Infect Dis. 2006 Sep 11;6:137. doi: 10.1186/1471-2334-6-137.
citation: Grumann D, Ruotsalainen E, Kolata J, Kuusela P, Jarvinen A, Kontinen VP, Broker BM, Holtfreter S. Characterization of infecting strains and superantigen-neutralizing antibodies in Staphylococcus aureus bacteremia. Clin Vaccine Immunol. 2011 Mar;18(3):487-93. doi: 10.1128/CVI.00329-10. Epub 2011 Jan 19.