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BacteremiaBACT_URIENCT05522764

Predictors of Infective Endocarditis Among Patients Managed for Staphylococcus Aureus Bacteremia, Particularly Staphylococcus Aureus Bacteriuria, and Time to Blood Culture Positivity

An observational study of Bacteremia and Endocarditis, Bacterial, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Staphylococcus aureus is a frequent cause of primary or secondary bacteremia. It is also responsible for many cases of infective endocarditis, for which the therapeutic management is specific. The frequency of infective endocarditis among Staphylococcus aureus bacteremias varies between 2.7% and 23.4%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bacteremia, Endocarditis, Bacterial
How many people
247 participants
Where
1 siteFrance
Study dates
18 Jul 2022to 31 Dec 2023
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: Patients over 18 years of age for whom blood cultures returned positive for S. aureus and a cytobacteriological examination of the urine was performed concomitantly with the positive blood culture for S. aureus, have been tested for infective endocarditis by echocardiography.

Who may be able to join

  • Patient over 18 years of age for whom:
  • Blood cultures returned positive for S. aureus
  • A cytobacteriological examination of the urine was performed concomitantly with the positive blood culture for S. aureus
  • Has been tested for infective endocarditis by echocardiography.
  • French-speaking patient

Who cannot join

  • Patient with S. aureus bacteremia who has not had an ECBU or echocardiography performed
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his or her data for this research

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

Other trials in France

About this study

Staphylococcus aureus is a frequent cause of primary or secondary bacteremia. It is also responsible for many cases of infective endocarditis, for which the therapeutic management is specific. The frequency of infective endocarditis among Staphylococcus aureus bacteremias varies between 2.7% and 23.4%. Many factors associated with the risk of developing endocarditis in patients with S. aureus bacteremia have been described. Two parameters of potential interest remain excluded from this work: blood culture growth time, a marker of bacterial inoculum, and the presence of bacteriuria, which is common during bacteremia. The objective of this study is to evaluate the interest of these two parameters in the prediction of the presence of endocarditis during S. aureus bacteremia. Investigators will conduct a retrospective study including all patients managed for Staphylococcus aureus bacteremia and in whom a urine culture was performed.

The primary objective is to describe the factors associated with the occurrence of endocarditis in patients managed for S. aureus bacteremia and who received a urine cytobacteriological examination (UCE).

The secondary objectives are: to evaluate the factors associated with the occurrence of S. aureus bacteriuria in patients with S. aureus bacteremia and to evaluate the risk factors for mortality in patients managed for S. aureus bacteremia.

Medical subject headings
Bacteremia, Endocarditis, Bacterial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Factors associated with the occurrence of endocarditis

    This outcome corresponds to the description of predictive factors for infective endocarditis in patients with S. aureus bacteremia.

    Measured: Month 1

Secondary outcomes (2)

  1. Factors associated with the occurrence of S. aureus bacteriuria

    This outcome corresponds to the comparison of patients with S. aureus bacteremia and same-germ bacteriuria to those without same-germ bacteriuria.

    Measured: Month 1

  2. Risk factors for mortality

    This outcome corresponds to the comparison of patients who died in the setting of their S. aureus bacteremia to surviving patients.

    Measured: Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start18 Jul 2022
  3. Primary completion19 Sep 2022
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Retrospective
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05522764
Sponsor's protocol ID
BACT_URIE
Acronym
BACT_URIE
Status last verified
Oct 2022
First submitted
29 Aug 2022
Last updated
1 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Al Mohajer M, Darouiche RO. Staphylococcus aureus Bacteriuria: Source, Clinical Relevance, and Management. Curr Infect Dis Rep. 2012 Dec;14(6):601-6. doi: 10.1007/s11908-012-0290-4.

    PubMed 22945379

  • Chang FY, Peacock JE Jr, Musher DM, Triplett P, MacDonald BB, Mylotte JM, O'Donnell A, Wagener MM, Yu VL. Staphylococcus aureus bacteremia: recurrence and the impact of antibiotic treatment in a prospective multicenter study. Medicine (Baltimore). 2003 Sep;82(5):333-9. doi: 10.1097/01.md.0000091184.93122.09.

    PubMed 14530782

  • Le Moing V, Alla F, Doco-Lecompte T, Delahaye F, Piroth L, Chirouze C, Tattevin P, Lavigne JP, Erpelding ML, Hoen B, Vandenesch F, Duval X; VIRSTA study group. Staphylococcus aureus Bloodstream Infection and Endocarditis--A Prospective Cohort Study. PLoS One. 2015 May 28;10(5):e0127385. doi: 10.1371/journal.pone.0127385. eCollection 2015.

    PubMed 26020939

  • Thwaites GE, Edgeworth JD, Gkrania-Klotsas E, Kirby A, Tilley R, Torok ME, Walker S, Wertheim HF, Wilson P, Llewelyn MJ; UK Clinical Infection Research Group. Clinical management of Staphylococcus aureus bacteraemia. Lancet Infect Dis. 2011 Mar;11(3):208-22. doi: 10.1016/S1473-3099(10)70285-1.

    PubMed 21371655

  • Tubiana S, Duval X, Alla F, Selton-Suty C, Tattevin P, Delahaye F, Piroth L, Chirouze C, Lavigne JP, Erpelding ML, Hoen B, Vandenesch F, Iung B, Le Moing V; VIRSTA/AEPEI Study Group. The VIRSTA score, a prediction score to estimate risk of infective endocarditis and determine priority for echocardiography in patients with Staphylococcus aureus bacteremia. J Infect. 2016 May;72(5):544-53. doi: 10.1016/j.jinf.2016.02.003. Epub 2016 Feb 22.

    PubMed 26916042

  • Abu Saleh O, Fida M, Asbury K, Narichania A, Sotello D, Bosch W, Vikram HR, Palraj R, Lahr B, Baddour LM, Sohail MR. Prospective Validation of PREDICT and Its Impact on the Transesophageal Echocardiography Use in Management of Staphylococcus aureus Bacteremia. Clin Infect Dis. 2021 Oct 5;73(7):e1745-e1753. doi: 10.1093/cid/ciaa844.

    PubMed 32569366

  • Horino T, Sato F, Hosaka Y, Hoshina T, Tamura K, Nakaharai K, Kato T, Nakazawa Y, Yoshida M, Hori S. Predictive factors for metastatic infection in patients with bacteremia caused by methicillin-sensitive Staphylococcus aureus. Am J Med Sci. 2015 Jan;349(1):24-8. doi: 10.1097/MAJ.0000000000000350.

    PubMed 25250988

  • Kaasch AJ, Fowler VG Jr, Rieg S, Peyerl-Hoffmann G, Birkholz H, Hellmich M, Kern WV, Seifert H. Use of a simple criteria set for guiding echocardiography in nosocomial Staphylococcus aureus bacteremia. Clin Infect Dis. 2011 Jul 1;53(1):1-9. doi: 10.1093/cid/cir320.

    PubMed 21653295

  • Huggan PJ, Murdoch DR, Gallagher K, Chambers ST. Concomitant Staphylococcus aureus bacteriuria is associated with poor clinical outcome in adults with S. aureus bacteraemia. J Hosp Infect. 2008 Aug;69(4):345-9. doi: 10.1016/j.jhin.2008.04.027. Epub 2008 Jul 3.

    PubMed 18602184

  • Kahn F, Resman F, Bergmark S, Filiptsev P, Nilson B, Gilje P, Rasmussen M. Time to blood culture positivity in Staphylococcus aureus bacteraemia to determine risk of infective endocarditis. Clin Microbiol Infect. 2021 Sep;27(9):1345.e7-1345.e12. doi: 10.1016/j.cmi.2020.11.007. Epub 2020 Nov 13.

    PubMed 33197608

Questions about this trial

What is this clinical trial studying?

An observational study of Bacteremia and Endocarditis, Bacterial, run by Fondation Hôpital Saint-Joseph at 1 site in France.

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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. 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 France. 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?

Results are not available in the source record.

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?

Factors associated with the occurrence of endocarditis (time frame: Month 1). 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 NCT05522764, which also lists 10 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 1 Nov 2022.

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