MedDataX Logo

Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia

NCT ID: NCT00548002

Last Updated: 2007-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-01-31

Study Completion Date

2002-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Staphylococcus Aureus Bacteremia Endocarditis Sepsis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Staphylococcus aureus bacteremia endocarditis sepsis fluoroquinolone rifampin levofloxacin trovafloxacin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 and 2

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

trovafloxacin and levofloxacin

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Helsinki

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eeva Ruotsalainen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Helsinki, HUS, Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16420547 (View on PubMed)

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.

Reference Type RESULT
PMID: 16965625 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21248153 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

210275

Identifier Type: -

Identifier Source: org_study_id