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CUSTOMIZED ANTIBIOTIC TREATMENT DURATION AMONG HOSPITALIZED PATIENTS WITH MODERATELY SEVERE COMMUNITY-ACQUIRED PNEUMONIA [CAT-CAP]
EU CTIS ID: 2023-504208-27-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient (≥18 years old)
- Negative viral respiratory testing (positive viral testing will be allowed only if bacterial documentation is confirmed by PCR or culture)
- Antibiotic treatment anticipated to be prescribed for a minimum of one additional day if the patient is not randomized into the experimental group
- Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria: o Fever (temperature > 38°C) or hypothermia (< 36°C) o Dyspnea o Cough o Production of purulent sputum o Crackles
- Radiological evidence of a new infiltrate (chest X-ray or CT scan)
- Treated for a minimum of 48 hours and a maximum of 7 days with antibiotics chosen according to the French recommendations for suspected CAP (excluding azithromycin due to its prolonged half-life) and 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: o apyrexia (T°C ≤ 37.8) o heart rate < 100/min o respiratory rate < 24/min, according to the patient's usual mode of oxygenation, o arterial oxygen saturation ≥ 92%, according to the patient's usual mode of oxygenation, o systolic blood pressure ≥ 90mmHg, The last occurring of these criteria must have appeared within the last 24 hours.
You likely can't join if
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency insufficiency with long-term oxygen therapy, ICU admission)
- Patient enrolled in another interventional clinical trial on antibiotic treatments
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, bone marrow transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)
- Suspected or confirmed legionellosis
- Any other infection necessitating concomitant antibiotic treatment (except if treated by oral fosfomycin, furadantin and pivmecillinam used in accordance with the marketing authorisations)
- Confirmed aspiration pneumonia or healthcare-associated pneumonia
See the full eligibility criteria
Who can join
- Adult patient (≥18 years old)
- Negative viral respiratory testing (positive viral testing will be allowed only if bacterial documentation is confirmed by PCR or culture)
- Antibiotic treatment anticipated to be prescribed for a minimum of one additional day if the patient is not randomized into the experimental group
- Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria: o Fever (temperature > 38°C) or hypothermia (< 36°C) o Dyspnea o Cough o Production of purulent sputum o Crackles
- Radiological evidence of a new infiltrate (chest X-ray or CT scan)
- Treated for a minimum of 48 hours and a maximum of 7 days with antibiotics chosen according to the French recommendations for suspected CAP (excluding azithromycin due to its prolonged half-life) and 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: o apyrexia (T°C ≤ 37.8) o heart rate < 100/min o respiratory rate < 24/min, according to the patient's usual mode of oxygenation, o arterial oxygen saturation ≥ 92%, according to the patient's usual mode of oxygenation, o systolic blood pressure ≥ 90mmHg, The last occurring of these criteria must have appeared within the last 24 hours.
- No other site of infection besides respiratory
- Affiliated to Health insurance or patients with government medical aid called AME
- 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 (Patient should be able to call and to answer to a phone call or to be with a relative who can help him to call or to answer questions notably raised by medical staff belonging to the investigational site)
- Patient presenting a 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/min, respiratory rate < 24/min, arterial oxygen saturation ≥ 90% on room air, systolic blood pressure ≥ 90mmHg
What rules you out
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency insufficiency with long-term oxygen therapy, ICU admission)
- Patient enrolled in another interventional clinical trial on antibiotic treatments
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, bone marrow transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)
- Suspected or confirmed legionellosis
- Any other infection necessitating concomitant antibiotic treatment (except if treated by oral fosfomycin, furadantin and pivmecillinam used in accordance with the marketing authorisations)
- Confirmed aspiration pneumonia or healthcare-associated pneumonia
- Contra-indications to study antibiotics
- Patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (for patients treated with fluoroquinolones)
- History of bacterial pneumonia less than 1 month prior to study inclusion
- Bronchopulmonary diseases : cystic fibrosis; severe bronchiectasis; lung cancer under active anti-cancer treatment (patients considered in remission and having received no treatment (chemotherapy, radiotherapy, targeted therapy or immunotherapy) for at least 6 months may be included); ongoing tuberculosis or major sequelae of tuberculosis
- Treatment of suspected CAP with azithromycin (due to its prolonged half-life)
- Concomitant steroid treatment (only for patients treated with fluoroquinolones antibiotics)
- Pregnant or breastfeeding woman
- More than 24 hours of efficacious antibiotics prior to hospital admission (except for oral fosfomycin, furadantin and pivmecillinam used in accordance with the marketing authorisations)
- Positive family history of aneurysm disease or congenital heart valve disease, patients diagnosed with pre-existing aortic aneurysm and/or dissection or heart valve disease, patients with presence of other risk factors or conditions predisposing: for both aortic aneurysm and dissection and heart valve regurgitation/incompetence (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behcet´s disease, hypertension, rheumatoid arthritis) or additionally .for aortic aneurysm and dissection (e.g. vascular disorders such as Takayasu arteritis or giant cell arteritis, or known atherosclerosis, or Sjögren’s syndrome) or additionally .for heart valve regurgitation/incompetence (only for patients treated with fluoroquinolones antibiotics)
- Life expectancy < 1 month
- Patient under legal guardianship (French “tutelle” or “curatelle”)
- Patient without fixed address
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.