Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

Completed · Phase 3

Conditions studied: Community Acquired Pneumonia

In brief

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.

Key facts

Study ID

NCT02559310

Run by

Nabriva Therapeutics AG

People needed

551

Starts

2015-09-01

Expected to finish

2017-05-01

Last updated by the study team

2019-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be male or female at least 18 years of age.
• Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.
• Have an acute illness (7 days 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
• 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 <35.0°C (95.0°F) measured orally or equivalent temperature from an alternate body site)
• Hypotension (systolic blood pressure <90 mmHg)
• Tachycardia (heart rate >100 beats/min)
• Tachypnea (respiratory rate >20 breaths/min)
• Have at least 1 other clinical sign or laboratory finding of CABP:
• Hypoxemia (i.e., O2 saturation <90% on room air or while receiving supplemental oxygen at subject's baseline requirement or PaO2 <60 mmHg)
• Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness)
• White blood cell (WBC) count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count
• Have radiographically-documented pneumonia within 48 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).
• Have a Pneumonia Outcomes Research Team (PORT) Risk Class ≥III.

You may not qualify if…

• Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization
• Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens
• Have been hospitalized for 2 or more 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. NOTE: Residence in an independent living facility is permitted.
• Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) 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).
• 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).
• Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).
• Require mechanical ventilation.

Where it is running

• Site 1008 — Shreveport, Louisiana, United States
• Site 1005 — Minneapolis, Minnesota, United States
• Site 1001 — Butte, Montana, United States
• Site 1009 — Akron, Ohio, United States
• Site 1002 — Dayton, Ohio, United States
• Site 1004 — Splendora, Texas, United States
• Site 3005 — La Plata, Buenos Aires, Argentina
• Site 3006 — Rosario, Santa Fe Province, Argentina
• Site 3003 — Córdoba, Argentina
• Site 3007 — Córdoba, Argentina
• Site 3001 — Córdoba, Argentina
• Site 3004 — Córdoba, Argentina
• Site 4003 — Mostar, Bosnia and Herzegovina
• Site 4001 — Tuzla, Bosnia and Herzegovina
• Site 4004 — Zenica, Bosnia and Herzegovina
• Site 3104 — Belo Horizonte, Minas Gerais, Brazil
• Site 3102 — Passo Fundo, Rio Grande Do Sol, Brazil
• Site 3103 — Campinas, São Paulo, Brazil
• Site 3101 — Sao Paulo Do Rio Preto, São Paulo, Brazil
• Site 4105 — Gabrovo, Bulgaria
• Site 4107 — Lovech, Bulgaria
• Site 4112 — Pernik, Bulgaria
• Site 4103 — Rousse, Bulgaria
• Site 4108 — Smolyan, Bulgaria
• Site 1006 — Hazard, Kentucky, United States

Full record on ClinicalTrials.gov

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