Bacterial InfectionsMHR-BCNCT03992703
Clinical Impact of Rapid AST Directly From Blood Cultures
An observational study of Bacterial Infections, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 31 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Clinical Impact of Rapid Susceptibility Testing on MHR-SIR Directly From Blood Cultures
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.
Read the detailed description
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
- Bacterial Infections
- Keywords
- Clinical impact, Bacteremia, Antibiotic, Blood cultures, Enterobacteriaceae, Staphylococcus aureus
- Medical subject headings
- Bacterial Infections, Bacteremia, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (4)
Percentage of patients with escalation and de-escalation of prescribed probabilistic antibiotic therapy
Evaluate the rendering impact of a rapid antibiotic susceptibility testing (8 hours) in bacteriemic patients compared to standard antibiotic susceptibility testing (24 hours) on escalation and de-escalation of prescribed probabilistic antibiotic therapy by percentage, after rendered results.
Measured: 6 months
Average number of days of broad-spectrum antibiotic therapy
Evaluate the rendering impact of a rapid antibiotic susceptibility testing (8 hours) in bacteriemic patients compared to standard antibiotic susceptibility testing (24 hours) on prescribing broad-spectrum antibiotic therapy by calculating average number of days for both groups.
Measured: 6 months
Average oral relay time for antibiotics
Evaluate the rendering impact of a rapid antibiotic susceptibility testing (8 hours) in bacteriemic patients compared to standard antibiotic susceptibility testing (24 hours) on antibiotics oral relay by calculating the average oral relay time for both groups.
Measured: 6 months
Intra-hospital mortality prevalence of infectious origin
Evaluate the rendering impact of a rapid antibiotic susceptibility testing (8 hours) in bacteriemic patients compared to standard antibiotic susceptibility testing (24 hours) on in-hospital mortality of infectious origin.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Apr 2019
- Primary completion30 Oct 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies 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
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Claude NGUYEN VAN, Doctor, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992703
- Sponsor's protocol ID
- MHR-BC
- Acronym
- MHR-BC
- Status last verified
- Apr 2023
- First submitted
- 14 Jun 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30149988Garnacho-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.
PubMed 26307060Brun-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.
PubMed 7674528Ferrer 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.
PubMed 24717459
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Rapid Susceptibility Testing on MHR-SIR Directly From Blood Cultures
- ClinicalTrials.gov ID
- NCT03992703
- Acronym / sponsor ID
- MHR-BC / MHR-BC
- Conditions
- Bacterial Infections
- Keywords
- Clinical impact, Bacteremia, Antibiotic, Blood cultures, Enterobacteriaceae, Staphylococcus aureus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- 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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 6 months
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).
4 secondary outcomes
Percentage of patients with escalation and de-escalation of prescribed probabilistic antibiotic therapy
Time frame: 6 months
Average number of days of broad-spectrum antibiotic therapy
Time frame: 6 months
Average oral relay time for antibiotics
Time frame: 6 months
Intra-hospital mortality prevalence of infectious origin
Time frame: 6 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 27 Apr 2023.
- Background: PubMed 30149988Perillaud 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.
- Background: PubMed 26307060Garnacho-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.
- Background: PubMed 7674528Brun-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.
- Background: PubMed 24717459Ferrer 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.
- PubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jean-Claude NGUYEN VAN, Doctor principal investigator
Fondation Hôpital Saint-Joseph
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 Bacterial Infections, 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 6 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: finished, as of the sponsor's last update on 27 Apr 2023. 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?
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?
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. (time frame: 6 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 NCT03992703, which also lists 4 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 27 Apr 2023.