Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia - Full Text View

Sponsored by:	Helsinki University
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00548002

Purpose

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

Condition	Intervention	Phase
Staphylococcus Aureus Bacteremia Endocarditis Sepsis	Drug: trovafloxacin and levofloxacin	Phase IV

MedlinePlus related topics: Endocarditis Sepsis

Drug Information available for: Levofloxacin Ofloxacin Ofloxacin hydrochloride Trovafloxacin Alatrofloxacin Alatrofloxacin mesylate Rifampin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Helsinki University:

Primary Outcome Measures:

Case fatality rate [ Time Frame: At 28 days and at 3 months ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood

Enrollment:	430
Study Start Date:	January 1999
Study Completion Date:	August 2002

Groups/Cohorts	Assigned Interventions
1 and 2 Patients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin).	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548002

Locations

Finland, HUS
Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital
Helsinki, HUS, Finland, 00029

Sponsors and Collaborators

Helsinki University

Investigators

Principal Investigator:

Eeva Ruotsalainen, MD

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

More Information

Publications of Results:

Ruotsalainen E, Jarvinen A, Koivula I, Kauma H, Rintala E, Lumio J, Kotilainen P, Vaara M, Nikoskelainen J, Valtonen V; The 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.

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.

Study ID Numbers:	210275
Study First Received:	October 22, 2007
Last Updated:	October 22, 2007
ClinicalTrials.gov Identifier:	NCT00548002
Health Authority:	Finland: Ethics Committee; Finland: National Agency for Medicines

Keywords provided by Helsinki University:

Staphylococcus aureus
bacteremia
endocarditis
sepsis

fluoroquinolone
rifampin
levofloxacin
trovafloxacin

Study placed in the following topic categories:

Bacterial Infections
Systemic Inflammatory Response Syndrome
Heart Diseases
Fluoroquinolones
Ofloxacin
Bacteremia
Endocarditis

Inflammation
Rifampin
Staphylococcal Infections
Sepsis
Gram-Positive Bacterial Infections
Trovafloxacin
Alatrofloxacin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Infective Agents, Urinary

Enzyme Inhibitors
Cardiovascular Diseases
Renal Agents
Infection
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009