Staphylococcus AureusFINLEVONCT00548002
Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia
An observational study of Staphylococcus Aureus and Bacteremia, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus, Bacteremia, Endocarditis
- What is being tested?
- trovafloxacin and levofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 430 participants
- Where
- 1 siteFinland
- Study dates
- Jan 1999to Aug 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling.
Who cannot join
- age younger than 18 years
- imprisonment
- proven or suspected pregnancy
- breastfeeding, epilepsy
- another bacteremia during the previous 28 days
- polymicrobial bacteremia (_>3 microbes)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital
Helsinki, HUS, 00029
About this study
To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard treatment, could reduce the high mortality and complication rates in Staphylococcus aureus bacteremia.
- Conditions
- Staphylococcus Aureus, Bacteremia, Endocarditis, Sepsis
- Being tested
- trovafloxacin and levofloxacin
- Keywords
- Staphylococcus aureus, bacteremia, endocarditis, sepsis, fluoroquinolone, rifampin, levofloxacin, trovafloxacin
- Medical subject headings
- Staphylococcal Infections, Bacteremia, Endocarditis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trovafloxacin and levofloxacinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 and 2 | Patients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin). Receives: Drug: trovafloxacin and levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case fatality rate
Measured: At 28 days and at 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startJan 1999
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Investigators
- Eeva Ruotsalainen, MD, Principal investigator, Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548002
- Sponsor's protocol ID
- 210275
- Acronym
- FINLEVO
- Status last verified
- Oct 2007
- First submitted
- 22 Oct 2007
- Last updated
- 23 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16420547Ruotsalainen 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.
PubMed 16965625Grumann 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.
PubMed 21248153
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia
- ClinicalTrials.gov ID
- NCT00548002
- Acronym / sponsor ID
- FINLEVO / 210275
- Conditions
- Staphylococcus Aureus, Bacteremia, Endocarditis, Sepsis
- Keywords
- Staphylococcus aureus, bacteremia, endocarditis, sepsis, fluoroquinolone, rifampin, levofloxacin, trovafloxacin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Aug 2002 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard treatment, could reduce the high mortality and complication rates in Staphylococcus aureus bacteremia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 and 2 | – | Drug: trovafloxacin and levofloxacinPatients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling.
Key exclusion criteria (13 listed)
- age younger than 18 years
- imprisonment
- proven or suspected pregnancy
- breastfeeding, epilepsy
- another bacteremia during the previous 28 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trovafloxacin and levofloxacinTrovafloxacin: <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 | Drug | 1 and 2 |
Primary outcome
Case fatality rate
Time frame: At 28 days and at 3 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2007.
- Results publication: PubMed 16420547Ruotsalainen 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.
- Results publication: PubMed 16965625Ruotsalainen 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.
- Derived from this study: PubMed 21248153Grumann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eeva Ruotsalainen, MD principal investigator
Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus and Bacteremia, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case fatality rate (time frame: At 28 days and at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00548002, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2007.