Levofloxacin for Community-acquired pneumonia

Inclusion criteria

• {"criterion_text":"- Hospital admission within 24 hours.\n- Radiologically new-onset chest infiltrate that is consistent with pneumonia and symptoms or signs also consistent with pneumonia, such as fever, cough, sputum, dyspnoea and/or chest pain.\n- The physician in charge of the patient’s treatment has decided that the patient should be treated with IV piperacillin/tazobactam.\n- C-reactive protein >50 OR central body temperature >38.0o C (1-3 of these fulfilled).\n- Age ≥ 18 years.\n- Able to give informed consent."}

Exclusion criteria

• {"criterion_text":"- Septic shock according to the sepsis III criteria; i.e., is organ dysfunction (defined as SOFA≥2) due to a dysregulated response to infection as well as persisting hypotension requiring vasopressors to maintain MAP≥65 mm Hg and serum lactate level>2 mmol/L (18 mg/dL) despite adequate volume resuscitation.\n- Reduced kidney function (eGFR < 20).\n- Expected transfer to ICU or death within 48 hours or a do not resuscitate ordination at time of recruitment.\n- Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.\n- Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).\n- Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women).\n- Oxygen requirement ≥5L/min to maintain 95% saturation.\n- Respiratory rate >24/min with relevant oxygen therapy.\n- Patient meets criteria for addition of macrolide to the antibiotic treatment.\n- Positive COVID or influenza test (PCR or antigen test).\n- Known allergy to levofloxacin or other fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone.\n- Prior tendinitis or tendon-rupture related to fluoroquinolone treatment.\n- Known allergy to β-lactam antibiotics.\n- Medical history of myasthenia gravis."}

Primary endpoints

• {"endpoint_text":"- Days alive and out of hospital at 14 days.","definition_or_measurement_approach":"Measured as days alive and out of hospital within 14 days."}

Secondary endpoints

• {"endpoint_text":"- Days alive and out of hospital at 30 days.\n- Days alive and out of hospital and without antibiotics at 30 days.\n- Proportion of patient with antibiotic-related side-effects\n- Differences in gut microbiome diversity and composition in stool and oral samples on day 5 and on day 60.\n- All-cause mortality at 30 days.\n- Proportion of patients converted to guideline-based therapy according to algorithm as described in the section titled “Procedures, patient monitoring and data collection”.\n- Proportion of patients readmitted, admitted to ICU or dead at 30 days.\n- CRP on day 5, continuous and binary (higher than on any day from 1 to 4 including baseline).\n- MAP ≤ 65 OR respiratory frequency > 25 OR pulse > 100 OR needing supplemental oxygen (1-4 of these fulfilled) on day 5.\n- PCT on day 5, continuous and binary (higher than on any day from 1 to 4 including baseline)\n- Temperature ≥ 38.0 on day 5.\n- Patient reported outcome measurements: Changes in Visual Analogue Scales for dyspnoea, cough, and fatigue from day 1 to day 5.","definition_or_measurement_approach":"Endpoints are measured at indicated time points (day 5, day 14, day 30, day 60). Examples: days alive and out of hospital counted over the time window; microbiome diversity/composition assessed in stool and oral samples on day 5 and day 60; CRP and PCT on day 5 reported as continuous values and binary (higher than any day 1-4 including baseline); patient-reported outcomes via Visual Analogue Scales from day 1 to day 5."}

Denmark

Earliest CTIS Part Ii Submission Date

30-06-2024

Latest Decision Or Authorization Date

11-07-2024

Processing Time Days

11

Number Of Sites

4

Number Of Participants

460

Primary sponsor

Full Name

Gentofte Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties codes: [\"1\",\"12\"] (as listed in source)","organisation_type":"Health care"}