AMOXICILLIN for Community-acquired pneumonia

Inclusion criteria

• {"criterion_text":"- Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients"}
• {"criterion_text":"- Patient admitted to the hospital for a CAP defined by at least two clinical signs of pneumonia (cough, sputum production, dyspnea, tachypnea, or pleuritic pain, abnormal lung auscultatory sounds, fever (temperature > 38°C) or hypothermia (< 36°C)) and radiological evidence of a new infiltrate confirming pneumonia"}
• {"criterion_text":"- Written informed consent obtained from patient prior to participation in the study (if the patient is unable to express in writing: consent by a trusted person)"}
• {"criterion_text":"- Patient understanding oral and written French"}
• {"criterion_text":"- Patients 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 a medical staff belonging to the investigational site"}

Exclusion criteria

• {"criterion_text":"- Patient requiring ICU admission"}
• {"criterion_text":"- Subjects with clinical or epidemiological environment leading to suspect a healthcare associated pneumonia with antibiotic resistant pathogen (including long-term care facility)"}
• {"criterion_text":"- Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae in the respiratory tract"}
• {"criterion_text":"- Suspicion of aspiration pneumonia"}
• {"criterion_text":"- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, ICU admission)"}
• {"criterion_text":"- History of bacterial pneumonia less than 1 month prior to study inclusion"}
• {"criterion_text":"- History of jaundice/hepatic impairment associated with amoxicillin/clavulanate acid"}
• {"criterion_text":"- History of hypersensitivity or allergy to beta-lactam or to any excipients included in study antibiotics"}
• {"criterion_text":"- Subject without health insurance"}
• {"criterion_text":"- Subject without home address or difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation)"}
• {"criterion_text":"- Patient under judicial protection"}
• {"criterion_text":"- Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, or chest computed tomography (CT) scan)"}
• {"criterion_text":"- Administration of any antibiotic treatment for more than 24 hours before inclusion"}
• {"criterion_text":"- Participation to another interventional study and having an exclusion period that is still in force during the screening phase or expected participation to another interventional study during participation to the CAPTAIN study"}
• {"criterion_text":"- Estimated Glomerular Filtration Rate < 30 ml/min"}
• {"criterion_text":"- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)"}
• {"criterion_text":"- Exacerbation of chronic obstructive pulmonary disease"}
• {"criterion_text":"- Life-threatening presentation expected to lead to possible imminent death"}
• {"criterion_text":"- Suspected atypical bacteria requiring combined antibiotics therapy"}
• {"criterion_text":"- Legionella suspected"}

Primary endpoints

• {"endpoint_text":"- clinical success rate at Day 30 (Montassier et al., 2019) since admission, defined as survival after completion of antibiotic treatment course, resolution of signs and symptoms of the infection (cough, purulent sputum production, dyspnea, or pleuritic chest pain) present at baseline with no new symptoms or complications attributable to CAP and no need for further antibacterial therapy","definition_or_measurement_approach":"Defined as survival after completion of antibiotic treatment course, resolution of signs and symptoms of the infection present at baseline with no new symptoms or complications attributable to CAP and no need for further antibacterial therapy (assessed at Day 30 since admission)"}

Secondary endpoints

• {"endpoint_text":"- Early clinical response will be defined as survival with improvement of one or more levels relative to baseline in two or more symptoms of CAP and no worsening of one or more levels in other symptoms of community-acquired bacterial pneumonia, without receipt of rescue antibacterial therapy","definition_or_measurement_approach":"Defined as survival with improvement of ≥1 level vs baseline in ≥2 CAP symptoms and no worsening in other symptoms, without receipt of rescue antibacterial therapy (Early clinical response)"}
• {"endpoint_text":"- The proposed endpoint of clinical cure after the end of treatment is defined as resolution in relevant signs and symptoms reported at baseline, no worsening of symptoms, and no change in antimicrobial regimen","definition_or_measurement_approach":"Defined as resolution of relevant baseline signs/symptoms, no worsening, and no change in antimicrobial regimen (clinical cure after end of treatment)"}
• {"endpoint_text":"- Days taking antibiotics from the first dose until the interruption of any antibiotic treatment during hospitalization and at late follow-up at Day 30 after hospital admission (to identify the use of any other antibiotic after hospital discharge defined as no IV, regain of autonomy identical to baseline, good clinical response and favorable evolution following initiation of antibiotics, other criteria left at the discretion of the investigators according to centers’ practices)","definition_or_measurement_approach":"Measured as number of days on antibiotic therapy from first dose until interruption during hospitalization and up to Day 30 follow-up; includes criteria to identify use of other antibiotics after discharge"}
• {"endpoint_text":"- All-cause mortality at Day 30 after hospital admission","definition_or_measurement_approach":"Measured as mortality from any cause assessed at Day 30 after hospital admission"}
• {"endpoint_text":"- Number of positive polymerase chain reaction (PCR)-positive Clostridium difficile among patients with diarrhea","definition_or_measurement_approach":"Measured as count/number of PCR-positive C. difficile cases among patients presenting with diarrhea"}
• {"endpoint_text":"- Number of deaths during hospitalization","definition_or_measurement_approach":"Measured as count of deaths occurring during the index hospitalization"}
• {"endpoint_text":"- Number of patients transferred to the ICU during the Day 30 follow- up","definition_or_measurement_approach":"Measured as count of patients requiring ICU transfer within the Day 30 follow-up period"}
• {"endpoint_text":"- Number of hospital readmissions and CAP recurrence up to day 30 from hospital admission","definition_or_measurement_approach":"Measured as counts of hospital readmissions and recurrences of CAP up to Day 30 from hospital admission"}
• {"endpoint_text":"- Number of adverse events attributable to antibiotics and number of days with adverse events up to day 30 from hospital admission","definition_or_measurement_approach":"Measured as count of adverse events attributable to antibiotics and total days with such events up to Day 30"}
• {"endpoint_text":"- Number of days of antibiotic treatment taken","definition_or_measurement_approach":"Measured as total number of days patient took antibiotic treatment"}
• {"endpoint_text":"- Total number of days in the hospital during the Day 30 follow-up","definition_or_measurement_approach":"Measured as total days hospitalized during the 30-day follow-up period"}
• {"endpoint_text":"- Agreement between early clinical response (main endpoint) and the investigator’s clinical judgement (clinical success or clinical failure)","definition_or_measurement_approach":"Assessed as the concordance between early clinical response endpoint and investigator's clinical judgement (success vs failure)"}

Methods

• Site-based screening of patients admitted to participating hospitals (emergency departments and hospital wards) in France for community-acquired pneumonia
• Follow-up phone calls to participants at Days 5 and 10 (phone contact requirement stated in inclusion criteria)

France

Earliest CTIS Part Ii Submission Date

19-12-2023

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

771

Number Of Sites

19

Number Of Participants

326

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France