Stop antibioticContinue the antimicrobial treatment
Stop antibiotic: Stop the antibiotic treatment on day S (stability criteria reached for 24 h or within 48 hours after the start of antibiotic treatment).
Continue the antimicrobial treatment: Continue the antimicrobial treatment for a duration predetermined by the investigator (usual practice, at least 5 days of treatment in total).
Study summary
The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting.
As the secondary objectives, the study aims
* To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of:
* Persistence of cure at Day 30 of antibiotic treatment
* All-cause mortality rate on Day 30 of antibiotic treatment
* Patients evolution of pneumonia symptoms and quality of life via 2 scores (CAP score, CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7 , at Day 15, and at Day 30 of antibiotic treatment.
* To compare between the 2 study arms at Day 30 of antibiotic treatment:
* The duration of antibiotic treatment;
* The length of hospital stay;
* The frequency and severity of adverse events during the 30 days after the start of treatment.
* To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Rate of cure at Day 15 after treatment initiation — Day 15 Cure at Day 15 will be defined by the association of:
* Persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure \> 90mmHg; oxygen saturation ≥ 92%; respiratory rate \< 24/min; normal mental status);
* No additional antibiotic treatment, targeting CAP, taken after the end of initial antibiotic treatment.
Patients who died, or are not cured as defined above, will be classified as failure at Day 15.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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