Haemophilus Influenzae Pneumonia in Adults (REHALIgraviTY)

Retrospective Hospital Study of Haemophilus Influenzae Pneumonia in Adults: Relapse and Severity

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.

Study Overview

• Status: Completed
• Conditions: Haemophilus Influenzae Pneumonia
• Intervention / Treatment: Other: Collection of data from the patient's medical file

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.

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92140
    • Hôpital Béclère
  • Clichy, France, 92110
    • Hopital Beaujon
  • Garches, France, 92380
    • Hopital Raymond Poincare
  • Le Kremlin-Bicêtre, France, 94270
    • Hôpital du Kremlin-Bicêtre
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75012
    • Hopital Saint-Antoine
  • Paris, France, 75010
    • Hôpital Lariboisière
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades
  • Paris, France, 75010
    • Hopital Saint-Louis
  • Paris, France, 75018
    • Hôpital Bichat
  • Paris, France, 75013
    • Hôpital La Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity associated factors in Haemophilus influenzae pneumonia	Identify the factors associated with severity in Haemophilus influenzae pneumonia. Severity is defined as: oxygen therapy > 3 L/minute or need for hospitalization in intensive care unit or death.	15 months
Antibiotic resistance profiles of Haemophilus influenza strains	Specify the antibiotic resistance profiles of the strains of Haemophilus influenzae responsible for pneumonia during the study period.	15 months
Pulmonary radiological patterns in Haemophilus influenzae pneumonia	Describe the pulmonary radiological patterns associated with Haemophilus influenzae pneumonia.	15 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Study Director: Olivier LORTHOLARY, MD, PhD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Adult patients; Haemophilus influenzae pneumonia; Relapse of Haemophilus influenzae pneumonia; Severity of Haemophilus influenzae pneumonia; Antibiotic resistance profiles of Haemophilus influenzae strains; Chest radiological patterns
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Pasteurellaceae Infections; Influenza, Human; Pneumonia; Haemophilus Infections
• Other Study ID Numbers: APHP240446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No