CEFTRIAXONE for Respiratory tract infections | Bacterial pneumonia | Tracheobronchitis | Reduced level of consciousness (coma states)

Inclusion criteria

• {"criterion_text":"- Endotracheal Intubation anticipated to last >48 hours\n- Age >17\n- Severe trauma or severe head trauma or Ischemic or hemorrhagic stroke or Status after cardiac arrest (ROSC) or Intoxications of the CNS or status epilepticus"}

Exclusion criteria

• {"criterion_text":"- Hopeless prognosis\n- Indication of systemic antibiotic therapy for suspected or documented infection\n- Active hemoptisis or pulmonary hemorrhage\n- Unstable thoracic cage\n- Undrained pneumothorax (inclusion acceptable after drainge)\n- Betalactam allergy"}

Primary endpoints

• {"endpoint_text":"- Incidence of device (cough simulator and subglottic aspiration equipment), antibiotic and infection-related severe adverse events from inclusion to day 14\n- Incidence of respiratory tract infections (pneumonia and tracheobronchitis) in intubated critically ill patients from inclusion to day 14","definition_or_measurement_approach":"- Incidence measured from inclusion up to day 14 (Study the incidence of device, antibiotic and infection-associated severe adverse events, days 1 to 14).\n- Incidence of respiratory tract infections (specifically pneumonia and tracheobronchitis) measured from inclusion up to day 14."}

Secondary endpoints

• {"endpoint_text":"- Duration of intubation (days with endotracheal tube plus tracheostomy canula) at 90 days\n- Total days of respiratory support (expressed as days without invasive and non-invasive mechanical ventilation or high-flow nasal canula) at 90 days\n- Days of ICU-stay\n- Points of the modified Rankin score on day 90\n- Day 90 mortality\n- Days without receiving systemic antibiotic therapy on day 14\n- Percentage of positive bacterial cultures of respiratory samples during first 14 days\n- Type of bacterial isolates (Gram-negatives/positives, community/nosocomial) in respiratory samples at day 14\n- Bacterial resistance mechanisms identified in cultures (extended-spectrum betalactamases, carbapenemases and methicillin, vancomycin, linezolid resistance) in respiratory or any other location until day 14.)\n- Percentage of subjects with bood-stained respiratory secretions\n- Number of daily catheter secretion suctioning sessions until day 14","definition_or_measurement_approach":"- Duration of intubation: number of days with endotracheal tube and tracheostomy cannula measured up to day 90.\n- Total days of respiratory support: measured as days without invasive + non-invasive ventilation + high-flow nasal cannula at 90 days (expressed as days of support up to day 90).\n- Days of ICU-stay: number of days in ICU.\n- Modified Rankin score on day 90: points on the scale at day 90.\n- Day 90 mortality: mortality status at day 90.\n- Days without systemic antibiotic therapy on day 14: count of days without systemic antibiotics up to day 14.\n- Percentage of positive bacterial cultures: proportion of respiratory samples positive during first 14 days.\n- Type of bacterial isolates: characterization (Gram-negative/positive, community vs nosocomial) in respiratory samples at day 14.\n- Bacterial resistance mechanisms: identification of specified resistance mechanisms in cultures up to day 14.\n- Percentage with blood-stained respiratory secretions: proportion of subjects with blood-stained secretions.\n- Number of daily catheter secretion suctioning sessions: count of suctioning sessions until day 14."}

Spain

Earliest CTIS Part Ii Submission Date

16-05-2025

Latest Decision Or Authorization Date

21-05-2025

Processing Time Days

5

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Hospital Clinico San Carlos

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Direx. Spain / Yaguo Technology Co. Ltd.","duties_or_roles":"Provide the cough simulation device and consumables.","organisation_type":""}
• {"country":"Spain","full_name":"Libera Médica","duties_or_roles":"Provides subglottic aspiration device and endotracheal tubes.","organisation_type":""}
• {"country":"Spain","full_name":"LABORATORIO REIG JOFRE, S.A.","duties_or_roles":"Marketing authorisation holder / supplier of ceftriaxone product (CEFTRIAXONA SALA 1 g).","organisation_type":""}