Haemophilus Influenzae PneumoniaREHALIgraviTYNCT06517277
Haemophilus Influenzae Pneumonia in Adults
An observational study of Haemophilus Influenzae Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemophilus Influenzae Pneumonia
- What is being tested?
- Collection of data from the patient's medical file
- How many people
- 203 participants
- Where
- 12 sitesFrance
- Study dates
- 26 Jul 2024to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Opposition formulated (following receipt of the study information note)
- Legal protection measure (impossibility of collecting non-opposition)
- Ventilator-associated pneumonia (VAP)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hôpital Béclère
Clamart, 92140
Hôpital Beaujon
Clichy, 92110
Hôpital Raymond Poincaré
Garches, 92380
Hôpital du Kremlin-Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Lariboisière
Paris, 75010
Hôpital Saint-Louis
Paris, 75010
Hôpital Saint-Antoine
Paris, 75012
Hôpital La Pitié Salpêtrière
Paris, 75013
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Necker-Enfants Malades
Paris, 75015
Hôpital Bichat
Paris, 75018
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Haemophilus Influenzae Pneumonia
- Being tested
- Collection of data from the patient's medical file
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data from the patient's medical fileOther
Collection of data from the patient's medical file. Relapses will be collected up to 3 months after Haemophilus influenzae pneumonia first episode.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Hospitalized patients for a Haemophilus influenzae pneumonia in 13 AP-HP hospitals between 09/01/2022 to 08/31/2023. Receives: Other: Collection of data from the patient's medical file |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 15 months
Pulmonary radiological patterns in Haemophilus influenzae pneumonia
Describe the pulmonary radiological patterns associated with Haemophilus influenzae pneumonia.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start26 Jul 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemophilus Influenzae PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Olivier LORTHOLARY, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517277
- Sponsor's protocol ID
- APHP240446
- Acronym
- REHALIgraviTY
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamon A, Garzaro M, Eiferman V, Abgrall S, Ibrahim R, Lecuyer H, Guillet C, Bleibtreu A, Rached B, Canoui E, Poupet H, De Castro N, Bercot B, Dinh A, Lafont E, Podglajen I, Paccoud O, Peiffer-Smadja N, Maataoui N, Kimseng H, Lanternier F, Lefort A, Serris A, Mageau A, Lortholary O. Severity and recurrence of Haemophilus influenzae pneumonia in adults are frequent and associated with distinct pathogenic patterns. Int J Infect Dis. 2026 Jun;167:108698. doi: 10.1016/j.ijid.2026.108698. Epub 2026 Apr 10.
PubMed 41967569
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Hospital Study of Haemophilus Influenzae Pneumonia in Adults: Relapse and Severity
- ClinicalTrials.gov ID
- NCT06517277
- Acronym / sponsor ID
- REHALIgraviTY / APHP240446
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Collection of data from the patient's medical fileHospitalized patients for a Haemophilus influenzae pneumonia in 13 AP-HP hospitals between 09/01/2022 to 08/31/2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age < 18 years
- Opposition formulated (following receipt of the study information note)
- Legal protection measure (impossibility of collecting non-opposition)
- Ventilator-associated pneumonia (VAP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of data from the patient's medical fileCollection of data from the patient's medical file. Relapses will be collected up to 3 months after Haemophilus influenzae pneumonia first episode. | Other | Patients |
Primary outcome
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.
3 secondary outcomes
Severity associated factors in Haemophilus influenzae pneumonia
Time frame: 15 months
Antibiotic resistance profiles of Haemophilus influenza strains
Time frame: 15 months
Pulmonary radiological patterns in Haemophilus influenzae pneumonia
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 41967569Hamon A, Garzaro M, Eiferman V, Abgrall S, Ibrahim R, Lecuyer H, Guillet C, Bleibtreu A, Rached B, Canoui E, Poupet H, De Castro N, Bercot B, Dinh A, Lafont E, Podglajen I, Paccoud O, Peiffer-Smadja N, Maataoui N, Kimseng H, Lanternier F, Lefort A, Serris A, Mageau A, Lortholary O. Severity and recurrence of Haemophilus influenzae pneumonia in adults are frequent and associated with distinct pathogenic patterns. Int J Infect Dis. 2026 Jun;167:108698. doi: 10.1016/j.ijid.2026.108698. Epub 2026 Apr 10.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier LORTHOLARY, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilus Influenzae Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse associated factors of Haemophilus influenzae pneumonia (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06517277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.