Clinical trial NCT06517277: Haemophilus Influenzae Pneumonia in Adults
Official title: Retrospective Hospital Study of Haemophilus Influenzae Pneumonia in Adults: Relapse and Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilus Influenzae Pneumonia
Keywords: Haemophilus influenzae pneumonia
Adult patients
Relapse of Haemophilus influenzae pneumonia
Severity of Haemophilus influenzae pneumonia
Antibiotic resistance profiles of Haemophilus influenzae strains
Chest radiological patterns
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients for a Haemophilus influenzae pneumonia in 14 hospitals of Assistance Publique - Hôpitaux de Paris, between 09/01/2022 to 08/31/2023.

Brief summary: Haemophilus influenzae is a Gram-negative coccobacillus capable of colonizing and infecting the human respiratory tract.

In the adult population, patients with an abnormality of their mucociliary epithelium and a deficiency in innate or adaptive immunity are particularly exposed.

The Infectious and Tropical Diseases department of Necker-Enfants Malades hospital has noted a recent increase in the number of cases of respiratory infections due to H. influenzae, with a high frequency of early relapses and recurrences despite appropriate treatment.

The research focuses on lower respiratory infections (pneumonia) caused by Haemophilus influenzae in adults, excluding pneumonia acquired under mechanical ventilation linked to Haemophilus influenzae in patients in 13 AP-HP hospitals during 12 months, from 09/01/2022 to 08/31/2023.

Detailed description: Haemophilus influenzae is a Gram-negative coccobacillus capable of colonizing and infecting the human respiratory tract.

In the adult population, patients with an abnormality of their mucociliary epithelium and a deficiency in innate or adaptive immunity are particularly exposed.

The Infectious and Tropical Diseases department of Necker-Enfants Malades hospital has noted a recent increase in the number of cases of respiratory infections due to H. influenzae, with a high frequency of early relapses and recurrences despite appropriate treatment.

The research focuses on lower respiratory infections (pneumonia) caused by Haemophilus influenzae in adults, excluding pneumonia acquired under mechanical ventilation linked to Haemophilus influenzae in patients in 13 AP-HP hospitals during 12 months, from 09/01/2022 to 08/31/2023.

The main objective of the study is to identify factors associated with relapse in hospitalized adult Haemophilus influenzae pneumonia.

Eligibility criteria: Inclusion Criteria:

* Acute respiratory symptoms: cough and/or dyspnea and/or purulent sputum or worsening of the color of the sputum for patients with chronic respiratory pathology, chest pain, desaturation defined by saturation \< 95% in ambient air
* Inflammatory syndrome: fever ≥ 38.5°C or CRP ≥ 30 mg/L
* Pulmonary imaging (x-ray or CT scan) compatible with pneumonia
* Good quality respiratory sample (for cytobacteriological examination of sputum (CBES) : leukocytes \> 25/mm3 and cells \< 10/mm3) positive in culture for H. influenzae at a significant threshold (for CBES ≥ 107 CFU/mL, for "standard" bronchial aspirate ≥ 105 CFU/mL, for protected bronchial aspiration ≥ 103 CFU/mL, for bronchoalveolar lavage ≥ 104 CFU/mL)
* Respiratory antibiotic therapy started by the clinician

Exclusion Criteria:

* Age \< 18 years
* Opposition formulated (following receipt of the study information note)
* Legal protection measure (impossibility of collecting non-opposition)
* Ventilator-associated pneumonia (VAP)

Primary outcomes:
measure: Relapse associated factors of Haemophilus influenzae pneumonia
timeFrame: 15 months
Secondary outcomes:
measure: Severity associated factors in Haemophilus influenzae pneumonia
timeFrame: 15 months
measure: Antibiotic resistance profiles of Haemophilus influenza strains
timeFrame: 15 months
measure: Pulmonary radiological patterns in Haemophilus influenzae pneumonia
timeFrame: 15 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital Béclère
city: Clichy
country: France
facility: Hôpital Beaujon
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital du Kremlin-Bicêtre
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Paris
country: France
facility: Hôpital Bichat
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier LORTHOLARY, MD, PhD
role: STUDY_DIRECTOR
References: