The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to moxifloxacin in the treatment of adult patients with community-acquired pneumonia.
The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of community-acquired bacterial pneumonia compared with moxifloxacin, or linezolid in the case of confirmed MRSA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
860
Antibacterial agent, 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
Antibacterial Agent, 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total
Antibacterial Agent, at local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Early Clinical Response
Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline.
Time frame: 96 (+/- 24) hours after the first dose of study drug
Early Clinical Response Plus Improvement in Vital Signs and no Worsening of the 4 Symptoms
Early clinical response with the addition of improvement in vital signs and no worsening of the following 4 symptoms: chest pain, cough, productive sputum, and difficulty breathing in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline. Improvement in vital signs defined as a return to normal of any abnormal vital signs at baseline, and no worsening (ie, be abnormal) of any vital sign that was normal at baseline.
Time frame: 96 (+/- 24) hours after the first dose of study drug
Clinical Outcome at Test of Cure
Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the ITT population.
Time frame: 5 to 10 days after the last dose of study drug
Clinical Outcome at End of Treatment
Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the ITT population.
Time frame: Up to 24 (+4) hours after the last dose of study drug
Microbiologic Response
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Melinta 306 Study Site
Montgomery, Alabama, United States
Melinta 306 Study Site
Newark, Delaware, United States
Melinta 306 Study Site
Coral Gables, Florida, United States
Melinta 306 Study Site
DeBary, Florida, United States
Melinta 306 Study Site
DeLand, Florida, United States
Melinta 306 Study Site
Fort Myers, Florida, United States
Melinta 306 Study Site
Miami, Florida, United States
Melinta 306 Study Site
Miami, Florida, United States
Melinta 306 Study Site
Louisville, Kentucky, United States
Melinta 306 Study Site
Natchitoches, Louisiana, United States
...and 80 more locations
Microbiological response for subjects in the MITT set will be based on results of the baseline and follow-up cultures and susceptibility testing or serology.
Time frame: 5 to 10 days after the last dose of study drug
All-cause Mortality
Time to all-cause Mortality was assessed on Day 28.
Time frame: Day 28 (+/- 2 days)