Community-Acquired Bacterial Pneumonia MedDRA version: 18.1 Level: LLT Classification code 10004051 Term: Bacterial pneumonia, unspecified System Organ Class: 100000004862
Conditions
Interventions
Product Name: lefamulin
Product Code: BC -3781
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: lefamulin
CAS Number: 1061337-516
Current Sponsor code: BC-3781
Concentr
Sponsors
Nabriva Therapeutics AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be male or female at least 18 years of age. 2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions. 3. Have an acute illness (7 days or less duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening): • Dyspnea. • New or increased cough. • Purulent sputum production. • Chest pain due to pneumonia. 4. Have at least 2 of the following vital sign abnormalities: • Fever (body temperature >38.0°C (100.4°F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature 100 beats/min). • Tachypnea (respiratory rate >20 breaths/min). 5. Have at least 1 other clinical sign or laboratory finding of CABP: • Hypoxemia (i.e., O2 saturation 10,000 cells/mm3 or 15% immature neutrophils (bands) regardless of total WBC count. 6. Have radiographically-documented pneumonia within 24 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia). 7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class =III. 8. If female, meets the following criteria: • Surgically sterile or =2 years postmenopausal, or if of childbearing potential (including being =65 years) yes F.1.3.1 Number of subjects for this age range 738
Exclusion criteria
Exclusion criteria: Each subject must NOT: 1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP =24 hrs before randomization • EXCEPTION: Subjects who have received >48 hrs of prior systemic antibacterial therapy for current episode of CABP with unequivocal clinical evidence of treatment failure and isolation of an organism from blood or respiratory tract that is resistant to the prior systemic antibacterial therapy unless the resistance is to fluoroquinolones and, in the case of MRSA, oxazolidinones. 2. Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens. 3. Have been hospitalized for =2 days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. 4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung). 5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis). 6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions). 7. Require mechanical ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • Evaluate the Early Clinical Response in the Microbiological Intent to Treat (microITT) Analysis Set. • Evaluate the Early Clinical Response PLUS improvement in vital signs in the ITT Analysis Set. • Evaluate the Investigator’s Assessment of Clinical Response at TOC in the microITT and Microbiologically Evaluable at TOC (ME-TOC) Analysis Sets. • Evaluate the By-Pathogen Microbiologic Response at TOC in the microITT and ME-TOC Analysis Sets. • Evaluate the safety and tolerability of lefamulin versus comparator in the Safety Analysis Set. • Evaluate 28 day all-cause mortality in the ITT Analysis Set. ;Main Objective: • Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (FDA endpoint). • Demonstrate the NI of lefamulin versus comparator with respect to the Investigator’s Assessment of Clinical Response at Test of Cure (TOC) (i.e., 5-10 days after the last dose of study drug) in the modified-ITT (mITT) and Clinically Evaluable at TOC (CE-TOC) Analysis Sets (EMA endpoint). ;Primary end point(s): • Proportion of Responders for ECR at 96 ± 24 hours following the first dose of study drug in the ITT Analysis Set (FDA) • Proportion of subjects with an IACR of Success at TOC in the mITT and CE-TOC Analysis Sets (Primary for EMA and secondary for FDA) ;Timepoint(s) of evaluation of this end point: 96 ± 24 hours following the first dose of study drug 5-10 days post last dose - test of cure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy will be assessed by ECR, IACR and by Microbiological Response. ;Timepoint(s) of evaluation of this end point: 5-10 days post last dose - test of cure | — |
Countries
Argentina, Bosnia and Herzegovina, Brazil, Bulgaria, Georgia, Hungary, Latvia, Lithuania, Netherlands, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Thailand, Ukraine, United States
Contacts
Public ContactClaudia Lell
Nabriva Therapeutics AG
Outcome results
None listed