Clinical Impact of Rapid AST Directly From Blood Cultures

NCT ID: NCT03992703

Last Updated: 2023-04-27

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

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-12-31

Brief Summary

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

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.

Detailed Description

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

The standard method based on diffusion on agar medium on conventional CBM allows antibiotic susceptibility results the test to be rendered within 24 hours. Many so-called rapid methods (Accelerate PhenoTM system, VITEK 2 Rapid Identification and Susceptibility Testing System,...) have been developed to improve antibiotic susceptibility testing speed from positive blood cultures. However, these approaches are costly and not exhaustive in terms of antibiotic panels tested.

The Mueller-Hinton Rapid-SIR (MHR-SIR) i2a medium has been developed. It is an agar medium allowing an early reading of antibiotic susceptibility test due to contrasting agents presence in culture medium which facilitates antibiotic susceptibility test results reading in less than 8 hours on a majority of fast-growing bacteria, in particular Enterobacteriaceae and golden staphylococci.

A prospective evaluation of the Mueller-Hinton Rapid-SIR (MHR-SIR) medium's performance directly from blood cultures was conducted in GHPSJ laboratory and published in 2018 with very satisfactory results obtained in less than 8 hours with a correlation \> 97% compared to the standard MH method (Results published in DMID ref.5) at a very moderate cost of 5 euros for 16 antibiotics in free choice; The additional cost compared to the traditional MH is 20% or 0.4 euros per agar. In view of excellent results of the study, this technique has replaced the traditional MH technique in GHPSJ laboratory since January 2017, allowing UMMC to propose more quickly adaptations of probabilistic antibiotic therapy.

The use of the MHR-SIR medium has never been evaluated in a clinical context. The objective of this pioneering study is to routinely evaluate the rendering clinical impact of the rapid antibiotic susceptibility test MHR-SIR (i2a) after 8 hours of incubation directly from the blood cultures.

Conditions

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

Bacterial Infections

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

RETROSPECTIVE

Study Groups

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

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

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

Jean-Claude NGUYEN VAN, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

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

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, France

Site Status

Countries

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

France

References

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

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.

Reference Type BACKGROUND
PMID: 30149988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26307060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7674528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24717459 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

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

MHR-BC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.