Skip to main content
OpenTrials
Completed

NCT Number: NCT06517277

Haemophilus Influenzae Pneumonia in Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Béclère, Clamart, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Relapse associated factors of Haemophilus influenzae pneumonia

    Time frame: 15 months

    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.

Secondary outcomes

  1. Severity associated factors in Haemophilus influenzae pneumonia

    Time frame: 15 months

    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.

  2. Antibiotic resistance profiles of Haemophilus influenza strains

    Time frame: 15 months

    Specify the antibiotic resistance profiles of the strains of Haemophilus influenzae responsible for pneumonia during the study period.

  3. Pulmonary radiological patterns in Haemophilus influenzae pneumonia

    Time frame: 15 months

    Describe the pulmonary radiological patterns associated with Haemophilus influenzae pneumonia.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: REHALIgraviTY

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.