Haemophilus Influenzae Pneumonia in Adults (NCT06517277) | Clinical Trial Compass
CompletedNot Applicable
Haemophilus Influenzae Pneumonia in Adults
France203 participantsStarted 2024-07-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relapse associated factors of Haemophilus influenzae pneumonia