Customized antibiotic treatment duration for hospitalized pneumonia patients
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
PHASE3 · Assistance Publique - Hôpitaux de Paris · NCT05903352
This study tests if giving hospitalized pneumonia patients antibiotics for a shorter, personalized time based on their recovery is just as effective as the usual longer treatment.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Garches) |
| Trial ID | NCT05903352 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older, hospitalized with suspected CAP and showing early clinical improvement after at least 48 hours of antibiotic treatment.
Not a fit: Patients who do not show early clinical improvement or have contraindications to the study's criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized antibiotic treatments, reducing unnecessary exposure and combating antibiotic resistance.
How similar studies have performed: Previous studies have indicated that shorter antibiotic courses can be safe for hospitalized CAP patients, suggesting potential success for this individualized approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Garches
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Community-Acquired Pneumonia, Antibiotic treatment duration, Antibiotic resistance, Infectious diseases