Piperacillin sodium; Tazobactam sodium for Acute exacerbation of chronic obstructive pulmonary disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years old\n- Post-smoking COPD confirmed according to GOLD 2020, whatever the stage (I-IV)\n- Acute exacerbation (defined by the appearance or increase of one or more of the usual signs/symptoms of COPD) with acute respiratory failure requiring admission to the ICU/Resuscitation and mechanical ventilation (invasive or non-invasive or nasal oxygen therapy high flow rate with FiO2 ≥ 50%)\n- Consent (patient, relative or inclusion in emergency situation)\n- Affiliation to a social security scheme."}

Exclusion criteria

• {"criterion_text":"- Delay between admission to hospital and admission to ICU/ICU greater than 3 days\n- Current pregnancy.\n- Antibiotic therapy formally indicated for a suspected or documented extra-respiratory infection\n- Congenital or acquired immunosuppression (congenital immune deficiency, progressive high-grade hematological malignancy, immunosuppressive drugs in the last 30 days including cytotoxic anti-cancer chemotherapy and anti-rejection drugs, corticosteroid therapy ≥ 20 mg/d of prednisone equivalent for at least 14 days, neutropenia, HIV with unknown or known CD4<200/µL in the last 6 months)\n- Tracheotomy\n- Bronchial dilatation/cystic fibrosis\n- Moribund patient (imminent death)\n- Patient deprived of liberty and/or protected by law\n- Patient already included in MULTI-EXA\n- Patient already included in a type 1 interventional clinical study (RIPH1) relating to antibiotics"}

Primary endpoints

• {"endpoint_text":"- Number of days alive without antibiotics on D28.","definition_or_measurement_approach":"Count of days alive without systemic antibiotics through day 28 (days alive and antibiotic-free by Day 28)."}

Secondary endpoints

• {"endpoint_text":"- Number of days with antibiotics in patients alive on D28\n- Number of days with broad-spectrum antibiotics in patients alive on D28\n- Incidence rate of nosocomial pneumonia on day 28;\n- Incidence rate of colonization/infection with multi-resistant bacteria on day 28;\n- Duration of stay in ICU/ICU at D28,\n- Length of hospital stay on D28;\n- Number of days alive without mechanical ventilation on D28\n- - Incidence rate of hospital-acquired pneumonia (including ventilator-acquired pneumonia) on day 28;\n- Mortality in ICU/ICU and in hospital (on day 28 and day 90);\n- - Number of additional EA-COPD(s) (requiring hospitalization and/or initiation of systemic corticosteroid therapy and/or antibiotic therapy) after the index EA-COPD (at D90);\n- Time between the index EA-COPD and the next EA-COPD (EA-COPD requiring hospitalization and/or initiation of systemic corticosteroid therapy and/or antibiotic therapy) (at D90);\n- CAT questionnaire (COPD Assessment Test) (at D90).","definition_or_measurement_approach":"Endpoints are measured as counts, incidence rates or standard clinical assessments at specified timepoints (Day 28 or Day 90) as stated: e.g. number of days with antibiotics among survivors at D28; incidence rates of pneumonia or colonisation at D28; mortality at D28 and D90; time-to-next-exacerbation by D90; CAT questionnaire score at D90."}

France

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

20-03-2026

Processing Time Days

508

Number Of Sites

13

Number Of Participants

204

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France