## Protocol Section
### Identification Module
**NCT ID:** NCT06425367

**Acronym:** MHR-Blood

**Brief Title:** Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients With Enterobacterales Bacteremia

**Official Title:** Impact of Performing a Rapid Antibiotic Susceptibility Test (MHR-SIR) on Antibiotic Therapy Adaptation in Adult Patients With Enterobacterales Bacteremia, Controlled, Randomized Cluster and Cross-over Study

#### Organization Study ID Info
**ID:** 650-MHR Blood
#### Organization
**Class:** OTHER
**Full Name:** Fondation Hôpital Saint-Joseph
### Status Module
#### Completion Date
**Date:** 2025-06-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondation Hôpital Saint-Joseph

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Bacteremia is defined as the presence of bacteria in the blood. They can potentially lead to life-threatening septic shock.

Effective probabilistic antibiotic therapy must therefore be initiated immediately after blood cultures have been taken.

To diagnose bacteremia, blood culture bottles must first be incubated, which allows bacterial growth and early detection. Then, as soon as the sample is positive, an antibiogram of the incriminated bacterium is carried out by inoculation on MH (Mueller Hinton) medium. This diffusion antibiogram is the reference method and is obtained 24 hours after the vial is positive, i.e. around 48 hours after blood cultures are taken.

American recommendations agree that it is crucial to use rapid diagnostic tests to obtain the antibiogram. Antibiotic susceptibility test data can be used to broaden the spectrum of antibiotics in the event of ineffective therapy. They can also be used to reduce the spectrum of broad-spectrum antibiotics. This is part of the proper use of antibiotics and the reduction of multi-resistant bacteria (MRB) or highly resistant bacteria (HRB). Finally, it is also possible to carry out an early oral relay, thus avoiding intravenous infusions and their complications, and potentially reducing hospitalization times.

The investigators have evaluated a rapid antibiogram by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. The investigators were able to obtain antibiogram results 7 hours after blood culture positivity, with excellent correlation compared with the standard method after 24 hours incubation on MH (Mueller-Hinton). The antibiotics tested were the same as with the standard method.

Secondly, The investigators were able to evaluate prospectively the impact of diffusion antibiotic susceptibility testing on MHR-SIR medium on early modification of antibiotic therapy in bacteremia, on 167 patients Antibiotic susceptibility test data on MHR-SIR enabled us to adapt antibiotic therapy 8 hours after blood culture positivity for 74 patients (44%). Antibiotic therapy was ineffective for 30 patients (18%) and was therefore extended. It also enabled us to reduce the spectrum of antibiotic therapy, in particular through early oral relay, for 44 patients (26%).

The aim of this multicenter trial is to validate on a large scale this strategy for obtaining rapid antibiotic susceptibility test results, with significant consequences in terms of optimizing antibiotic therapy.

### Conditions Module

**Conditions:**

- Bacteremia

**Keywords:**

- antibiogram

- bacteremia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** cluster cross-over randomized trial

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 960

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** rapid antibiotic susceptibility testing by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. Antibiotic susceptibility test results are obtained 7 hours after blood culture positivity

**Intervention Names:**

- Diagnostic Test: Antibiotic susceptibility testing

**Label:** MHR SIR

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard antibiotic susceptibility testing by diffusion on MH (Mueller-Hinton ) medium from the blood culture bottle Antibiotic susceptibility test results are obtained 24 hours after blood culture positivity

**Intervention Names:**

- Diagnostic Test: Antibiotic susceptibility testing

**Label:** MH

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MH

- MHR SIR

**Description:** antibiotic susceptibility testing is performed on MHR-SIR or MH medium depending on randomization

**Name:** Antibiotic susceptibility testing

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** percentage of patients with Enterobacterales bacteremia for whom antibiotic therapy was effective against the incriminating bacterium within 12 hours of a positive blood culture, according to the results of the antibiogram.

**Measure:** Effective Antiobiotherapy

**Time Frame:** 12 hours

#### Secondary Outcomes

**Description:** Time between blood sampling and antibiogram results

**Measure:** Time Frame

**Time Frame:** 3days

**Description:** After obtaining the antibiogram result, was the antibiotherapy modified (Yes or No) and if yes, was it for narrowing the antibiotic spectra (yes or no)

**Measure:** type of Antibiotherapy spectra modification

**Time Frame:** 2 days

**Description:** in hours

**Measure:** Time necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results

**Time Frame:** 2 days

**Description:** in days

**Measure:** time between the start of intravenous antibiotic therapy and oral antibiotics.

**Time Frame:** 1month

**Description:** In days,

**Measure:** length of hospital stay

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age \>= 18
* Patient hospitalized in a clinical department of each participating center
* Patient managed in the context of bacteremia (microbiological criterion = positive blood culture)
* Patient with positive blood culture for Enterobacterales
* Patient affiliated to a health insurance scheme
* Patient/relative having given free, informed and express oral consent

Exclusion Criteria:

* Patients with non-enterobacterial bacteremia
* Patient under guardianship
* Patient deprived of liberty
* Patient under court protection
* Pregnant or breast-feeding patient

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** crc@ghpsj.fr

**Name:** Helene BEAUSSIER

**Phone:** +33144127038

**Role:** CONTACT

**Contact 2:**

**Email:** jcourtiade@ghpsj.fr

**Name:** Juliette COURTIADE MAHLER

**Phone:** +33144127963

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Fondation Hôpital Saint-Joseph

**Name:** Jean Claude NGUYEN VAN, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

- ID: D000018805

- Term: Sepsis

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M18877

- Name: Bacteremia

- Relevance: HIGH

- As Found: Bacteremia

- ID: M7380

- Name: Disease Susceptibility

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M20864

- Name: Sepsis

- Relevance: LOW

- As Found: Unknown

- ID: M16869

- Name: Toxemia

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016470

- Term: Bacteremia

### Intervention Browse Module - Ancestors

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: HIGH

- As Found: Initial

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000900

- Term: Anti-Bacterial Agents

### Misc Info Module

- Version Holder: 2024-05-31
