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

Bacteremia Clinical Trial

— BACT_URIE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05522764
• Other study ID #: BACT_URIE
• Status: Active, not recruiting
• Start date: July 18, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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%. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 247
• Est. completion date: December 31, 2023
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bacteremia
• Bacteriuria
• Endocarditis
• Endocarditis, Bacterial

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Thwaites GE, Edgeworth JD, Gkrania-Klotsas E, Kirby A, Tilley R, Török 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 1
Secondary	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.	Month 1
Secondary	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.	Month 1