## Protocol Section
### Identification Module
**NCT ID:** NCT03927079

**Acronym:** ABBA

**Brief Title:** Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage

**Official Title:** Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage

#### Organization Study ID Info
**ID:** PI2018_843_0032
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire, Amiens
### Status Module
#### Completion Date
**Date:** 2023-06-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-06

**Type:** ACTUAL

**Last Update Submit Date:** 2023-09-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2019-04-23

**Type:** ACTUAL

**Status Verified Date:** 2023-09

#### Study First Post Date
**Date:** 2019-04-25
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-23
**Study First Submit QC Date:** 2019-04-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire, Amiens

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Respiratory infections are common and sometimes very severe. An insufficient dosage of the antibiotic could lead to a treatment failure A correct plasmatic antibiotic concentration is not a guarantee of a clinical success as it could not be a reflect of pulmonary concentration. The aim of this study is to determinate the predictive factors of pulmonary penetration of antibiotics in patients with a beta lactamines failure and who undergoes a flexible bronchoscopy.

**Detailed Description:** To check if pulmonary concentrations of antibiotic are enough we will measure antibiotic concentration in the broncho-alveolar lavage (BAL). This technique which is clinically relevant and reliable could determinate the pulmonary diffusion level for antibiotics by calculating the ratio between plasmatic and intra-alveolar antibiotic concentration. This ratio will be correlated with potential limitation factors of pulmonary diffusion as respiratory diseases (COPD, cystic fibrosis, fibrosis...), sepsis, hypoalbuminemia. We have chosen to study the beta lactamin antibiotics because they are the most frequently used in pneumonia. Moreover, the beta lactamins pulmonary diffusion is likely to be the lowest. Finally, for patients with a known pathogen, we will divide this pulmonary concentration with minimal inhibitory concentration (MIC). Indeed, in severe pneumonia, to be sure of bactericidal activity, a pulmonary concentration of beta lactamines should be always higher than 4 to 5 times MIC.

### Conditions Module

**Conditions:**

- Antibiotics

- Pneumonia

**Keywords:**

- Antibiotics

- Pneumonia

- broncho-alveolar lavage

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 101

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration

**Name:** measure of intra-alveolar antibiotic concentration in µg/ml

**Type:** BIOLOGICAL

#### Intervention 2

**Description:** included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration

**Name:** broncho-alveolar lavage (BAL)

**Type:** PROCEDURE

#### Intervention 3

**Description:** included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic

**Name:** blood test to measure plasmatic antibiotic concentration in µg/ml

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** pulmonary diffusion level for beta lactamins is determined by ratio between bronchoalveolar concentration and plasmatic concentration of tested antibiotics

**Measure:** pulmonary diffusion level for beta lactamins

**Time Frame:** on the day of the bronco-alveolar lavage

#### Secondary Outcomes

**Description:** measure of apyrexia duration in days

**Measure:** measure of apyrexia duration in days

**Time Frame:** from day of inclusion to 15 days after inclusion

**Description:** duration in days for regression of the biological inflammatory syndrome (CRP concentration in mg/l divided by 2)

**Measure:** duration in days for regression of the biological inflammatory syndrome

**Time Frame:** from day of inclusion to 15 days after inclusion

**Description:** measure of length of hospitalisation in days

**Measure:** measure of length of hospitalisation

**Time Frame:** from day of inclusion to 15 days after inclusion

**Description:** 28-day mortality will be measured

**Measure:** Number of deaths at 28-day

**Time Frame:** 28 days after inclusion

**Description:** virus presence will be detected in bronchoalveolar lavage (BAL)

**Measure:** virus presence in BAL

**Time Frame:** day of bronchoalveolar lavage (BAL)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients who undergo a flexible bronchoscopic lavage and with a beta lactamines treatment as cephalosporin of 3rd generation (CEFTRIAXONE / CEFOTAXIME, CEFTAZIDIME), of 4th generation (CEFEPIM), or AMOXICILLIN-CLAVULANIC ACID, or PIPERACILLIN-TAZOBACTAM
* patient major
* informed and signed consent form

Exclusion Criteria:

* patient under chronic dialysis
* patient placed under judicial protection

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Amiens

**Country:** France

**Facility:** CHU Amiens

**Zip:** 80480

#### Overall Officials

**Official 1:**

**Affiliation:** CHU Amiens

**Name:** Claire Andrejak, Pr

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M13904

- Name: Pneumonia

- Relevance: HIGH

- As Found: Pneumonia

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011014

- Term: Pneumonia

### Intervention Browse Module - Ancestors

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000995

- Term: Antitubercular Agents

- ID: D000002614

- Term: Chelating Agents

- ID: D000064449

- Term: Sequestering Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### 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: HIGH

- As Found: Initial

- ID: M7296

- Name: Dimercaprol

- Relevance: HIGH

- As Found: Isavuconazonium

- ID: M4311

- Name: Antitubercular Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5860

- Name: Chelating Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000904

- Term: Antibiotics, Antitubercular

- ID: D000004112

- Term: Dimercaprol

### Misc Info Module

- Version Holder: 2024-05-24
