Clinical Impact of Rapid AST Directly From Blood Cultures

NCT03992703 | Completed

• 1 other identifier: MHR-BC
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Bacteremia is defined as pathogenic bacteria presence in blood as evidenced by positive blood cultures. These bacteremia have significant consequences in terms of morbidity and mortality (ref. 1,2,3). They can lead to a state of septic shock that is life-threatening for the patient and must be treated as a matter of urgency. Any delay in treatment is detrimental to the patient. Management is based on prescription of probabilistic antibiotic therapy as soon as bacteremia is suspected. At the Groupe Hospitalier Paris Saint Joseph (GHPSJ), as soon as a blood culture is known to be positive, the Mobile Clinical Microbiology Unit (UMMC) is notified in real time. The UMMC infectiologist, in consultation with the microbiologist, evaluates microbiological data and compares them with clinical data in order to prescribe probabilistic antibiotic therapy in the patient's bed. The possible adaptation of antibiotic treatment then depends on the results of antibiotic susceptibility test. Early adaptation of antibiotic treatment to antibiotic susceptibility data, to reassess ineffective treatment or to reduce antibiotic therapy spectrum, significantly improves patient prognosis: it is therefore important that the laboratory makes antibiotic susceptibility test results available to the clinician as early as possible.

Conditions

Bacterial Infections

Keywords

Clinical impact; Bacteremia; Antibiotic; Blood cultures; Enterobacteriaceae; Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• Differences in average time between the prescribing physician's request for examination and the first change in prescribed probabilistic antibiotic therapy following the rendering of results between two groups of patients.

  Differences in average time between the prescribing physician's request for examination and the first change in prescribed probabilistic antibiotic therapy following the rendering of results between * a "standard strategy" group that has been treated with antibiotic susceptibility testing on a conventional Mueller-Hinton medium with reading after 24 hours of incubation (Period 1: from July 1, 2015 to December 31, 2016); * a "rapid strategy" group that has been treated with antibiotic susceptibility testing on a rapid Mueller-Hinton medium after 8 hours of incubation (period 2: January 1, 2017 to June 30, 2018). Prescribing changes taken into account include the introduction of an antibiotic, a change in the prescribed antibiotic or a change in its dosage (escalation, de-escalation).

  6 months

Secondary Outcomes (4)

• Percentage of patients with escalation and de-escalation of prescribed probabilistic antibiotic therapy

  6 months

• Average number of days of broad-spectrum antibiotic therapy

  6 months

• Average oral relay time for antibiotics

  6 months

• Intra-hospital mortality prevalence of infectious origin

  6 months

Study Arms (2)

Standard strategy

This group has been treated with antibiotic susceptibility testing on a conventional Mueller-Hinton medium with reading after 24 hours of incubation (Period 1: from July 1, 2015 to December 31, 2016)

Rapid strategy

This group has been treated with antibiotic susceptibility testing on a rapid Mueller-Hinton medium after 8 hours of incubation (period 2: January 1, 2017 to June 30, 2018)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a positive blood culture and whose antibiotic susceptibility test was performed on conventional Mueller-Hinton medium between July 1, 2015 and June 30, 2018

You may qualify if:

• Patient hospitalized in a clinical department of the Groupe Hospitalier Paris Saint-Joseph
• Patient for whom a blood culture and antibiotic susceptibility test have been prescribed in the event of suspected bacteremia
• Patient with a positive blood culture with enterobacteriaceae or Gram-positive cocci suggestive of Staphylococcus sp.
• Patient whose antibiotic susceptibility test was performed on conventional Mueller-Hinton medium between July 1, 2015 and December 31, 2016 or on rapid Mueller-Hinton medium between January 1, 2017 and June 30, 2018 (date of antibiotic susceptibility test)
• Adult patient (age \> 18 years)
• Patient with social care

You may not qualify if:

• Bacteremic patient with bacteria other than enterobacteriaceae or Gram-positive cocci suggestive of Staphylococcus sp.
• Patient objecting to use of their data for this research
• Patient under guardianship or curatorship (unless consent is provided)
• Patient deprived of liberty
• Patient under justice protection

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (4)

• Perillaud C, Pilmis B, Diep J, Pean de Ponfilly G, Vidal B, Couzigou C, Mizrahi A, Lourtet-Hascoet J, Le Monnier A, Nguyen Van JC. Prospective evaluation of rapid antimicrobial susceptibility testing by disk diffusion on Mueller-Hinton rapid-SIR directly on blood cultures. Diagn Microbiol Infect Dis. 2019 Jan;93(1):14-21. doi: 10.1016/j.diagmicrobio.2018.07.016. Epub 2018 Jul 31.

  PMID: 30149988 BACKGROUND

• Garnacho-Montero J, Gutierrez-Pizarraya A, Escoresca-Ortega A, Fernandez-Delgado E, Lopez-Sanchez JM. Adequate antibiotic therapy prior to ICU admission in patients with severe sepsis and septic shock reduces hospital mortality. Crit Care. 2015 Aug 27;19(1):302. doi: 10.1186/s13054-015-1000-z.

  PMID: 26307060 BACKGROUND

• Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Regnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.

  PMID: 7674528 BACKGROUND

• Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.

  PMID: 24717459 BACKGROUND

Related Links

• Pubmed

MeSH Terms

Conditions

Bacterial Infections; Bacteremia; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Study Officials

• Jean-Claude NGUYEN VAN, Doctor

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 20, 2019
• Study Start: April 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2020
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)