LEVOFLOXACIN for Community-acquired pneumonia

Stratification factors

• Respiratory comorbidity (COPD, asthma, no respiratory comorbidity)

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- C-reactive protein >50 OR central body temperature >38.0 °C (1-2 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:41 sequential organ failure assessment (SOFA) score ≥2) and suspected infection (according to attending physician) and persisting hypotension requiring vasopressors to maintain MAP≥65 mmHg and serum lactate level>2 mmol/L (18 mg/dL) despite adequate volume resuscitation (30 mL/kg crystalloid within 3 hours).\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 ≥5 L/min to maintain acceptable saturation assessed by the treating physician.\n- Respiratory rate >24/min with relevant oxygen therapy\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, including tendinitis or tendon-rupture related to fluoroquinolone treatment\n- Unexplained symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia)\n- Medical history of myasthenia gravis\n- Reduced kidney function (eGFR < 20)\n- A clinical state where the physician believes that chance of survival for 48 hours at time of recruitment is minimal."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with a drop in FEV1 of 20% or 300mL one hour following the first inhalation.","definition_or_measurement_approach":"FEV1 measured at baseline and one hour after the first inhalation; primary outcome is the proportion meeting either a ≥20% relative decrease or an absolute decrease ≥300 mL at one hour post-first inhalation."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with a drop in FEV1 of 20% or 300mL from baseline to day 4 or discharge, whichever comes first.\n- CRP on day 4 higher than on any day from 1 to 3 including baseline.\n- MAP ≤ 65 OR respiratory frequency > 25 OR pulse > 100 OR needing supplemental oxygen (1-4 of these fulfilled) on day 4.\n- PCT on day 4 higher than baseline.\n- Temperature ≥ 38.0 °C on day 4.\n- Patient reported outcome measurements: Changes in Visual Analogue Scales for dyspnoea, cough and fatigue from baseline to day 4.","definition_or_measurement_approach":"FEV1: spirometry comparing baseline to day 4 or discharge. CRP and PCT: blood biomarker levels measured on specified days and compared to earlier values. Clinical criteria (MAP, respiratory rate, pulse, need for supplemental oxygen): assessed clinically on day 4. Temperature: measured on day 4. Patient-reported outcomes: Visual Analogue Scales for dyspnoea, cough and fatigue measured at baseline and day 4; change scores analyzed."}

Denmark

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

01-10-2025

Processing Time Days

475

Number Of Sites

6

Number Of Participants

36

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","organisation_type":"Health care"}
• {"country":"","full_name":"Novo Nordisk Foundation","duties_or_roles":"Source of monetary support","organisation_type":""}