Haemophilus Influenzae Pneumonia in Adults

NCT06517277 | Completed

• 1 other identifier: APHP240446
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 12

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.

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

Outcome Measures

Primary Outcomes (1)

• Relapse associated factors of Haemophilus influenzae pneumonia

  Relapse associated factors with the Haemophilus influenzae pneumonia in hospitalized adult. Relapse of Haemophilus influenzae pneumonia defined as: * Definite relapse: acute respiratory symptoms (cough and/or dyspnea and/or purulent sputum), inflammatory syndrome (clinical: fever ≥ 38.5°C or biological: CRP ≥ 30 mg/L), respiratory antibiotic therapy started by the clinician, new good quality respiratory sample positive in culture for Haemophilus influenzae within 90 days following the first episode. * Probable relapse: acute respiratory symptoms, inflammatory syndrome (clinical: fever ≥ 38.5°C or biological: CRP ≥ 30 mg/L), respiratory antibiotic therapy started by the clinician, absence of microbiological documentation of the new episode, within 30 days following the first episode.

  15 months

Secondary Outcomes (3)

• Severity associated factors in Haemophilus influenzae pneumonia

  15 months

• Antibiotic resistance profiles of Haemophilus influenza strains

  15 months

• Pulmonary radiological patterns in Haemophilus influenzae pneumonia

  15 months

Study Arms (1)

Patients

Hospitalized patients for a Haemophilus influenzae pneumonia in 13 AP-HP hospitals between 09/01/2022 to 08/31/2023.

Other: Collection of data from the patient's medical file

Interventions

Collection of data from the patient's medical file OTHER

Collection of data from the patient's medical file. Relapses will be collected up to 3 months after Haemophilus influenzae pneumonia first episode.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (12)

Hôpital Béclère

Clamart, 92140, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Raymond Poincaré

Garches, 92380, France

Location

Hôpital du Kremlin-Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital La Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Study Officials

• Olivier LORTHOLARY, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 26, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)