Customized antibiotic treatment duration for hospitalized pneumonia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates whether an individualized approach to antibiotic treatment duration for hospitalized patients with community-acquired pneumonia (CAP) is as effective as the standard treatment duration. The study aims to determine if stopping antibiotics based on patient stability after at least 48 hours is non-inferior to the standard duration in terms of cure persistence and mortality rates. Participants will be monitored for their pneumonia symptoms and quality of life at various intervals during treatment. This pragmatic, multicenter trial will involve patients admitted to the hospital with suspected CAP who require antibiotics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patient (≥18 years old)
* Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria:

  * Fever (temperature \> 38°C) or hypothermia (\< 36°C)
  * Dyspnea
  * Cough
  * Production of purulent sputum
  * Crackles
* Radiological evidence of a new infiltrate (chest X-ray or CT scan)
* Negative viral respiratory testing
* Treated for a minimum of 48 hours with antibiotics (excluding azithromycin due to its prolonged half-life)Presenting with an early clinical response within the last 24 hours (up to 7 days after the start of antibiotic treatment, if planned treatment duration \> 7 days), defined by the presence of all the following criteria:apyrexia (T°C ≤ 37.8)heart rate \< 100/minrespiratory rate \< 24/min, according to the patient's usual mode of oxygenation,arterial oxygen saturation ≥ 92%, according to the patient's usual mode of oxygenation,Patient currently under antibiotic treatment for his suspected CAP (i.e. the last dose of ATB has been administered to the patient less than 24 hours ago)
* Patient presenting a clinical response within the last 24 hours defined by the presence of all the following criteria:

  * apyrexia (T°C ≤ 37.8)
  * heart rate \< 100/min
  * respiratory rate \< 24/min, according to the patient's usual mode of oxygenation,
  * arterial oxygen saturation ≥ 92%, according to the patient's usual mode of oxygenation,
  * systolic blood pressure ≥ 90mmHg, The last occurring of these criteria must have appeared within the last 24 hours.
* The antibiotic treatment for suspected CAP has started at least 48 hours ago and at most 6 days ago
* No other site of infection besides respiratory
* Affiliated to Health insurance
* Has given informed consent
* Patient understanding oral and written French, or presence of a relative who can explain and help him complete the study documents

Exclusion Criteria:

* Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
* Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4\<200/mm3)
* Suspected or confirmed legionellosis
* Any other infection necessitating concomitant antibiotic treatment
* Confirmed or suspected aspiration pneumonia or healthcare-associated pneumonia
* Treatment of suspected CAP with azithromycin (due to its prolonged half-life)
* Concomitant steroid treatment (only for patients treated with fluoroquinolones antibiotics)
* Pre-existing aortic aneurysm or dissection, family history of aortic aneurysm or dissection, Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arthritis, uncontrolled arterial hypertension, atherosclerosis (only for patients treated with fluoroquinolones antibiotics)
* Pregnant or breastfeeding woman
* Life expectancy \< 1 month
* Patient under legal guardianship (French "tutelle" or "curatelle")
* Patient without fixed address
* Patient enrolled in another interventional clinical trial on CAP treatment

Where it's running

• Infectious diseases department, Raymond-Poincaré Hospital - APHP
  Garches, France Recruiting

Study contacts

• Principal investigator: Aurélien Dihn, MD, PhD — Infectious diseases department, Raymond-Poincaré Hospital - APHP
• Study coordinator: Aurélien Dinh, MD, PhD
• Email: aurelien.dinh@aphp.fr
• Phone: + 33 (0)1 47 10 44 32

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.