Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia
NCT ID: NCT02679573
Last Updated: 2020-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
860 participants
INTERVENTIONAL
2016-12-14
2018-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Delafloxacin
IV delafloxacin with potential to switch to oral delafloxacin
Delafloxacin
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
Moxifloxacin/Linezolid
IV moxifloxacin with potential to switch to oral moxifloxacin, and potential to switch moxifloxacin to IV linezolid for confirmed MRSA
Moxifloxacin
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
Linezolid
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
Interventions
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Delafloxacin
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
Moxifloxacin
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
Linezolid
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening)
* Cough
* Production of purulent sputum consistent with bacterial infection
* Difficulty breathing
* Chest pain due to pneumonia
AND have at least 2 of the following findings:
* Fever (oral temperature \>38.0°C)
* Hypothermia (oral temperature \<35.0°C)
* Tachycardia (heart rate \>100 beats/min)
* Tachypnea (respiratory rate \>18 breaths/min)
AND have at least 1 of the following findings:
* Hypoxemia (oxygen saturation \<90% or PaO2 \< 60 mmHg) on room air or with subject's baseline (pre-CABP under study) supplemental oxygen
* Clinical evidence of pulmonary consolidation and/or presence of pulmonary rales
* An elevated white blood cell count (WBC) \>10,000/mm3 or 15% immature neutrophils (bands), regardless of total peripheral WBC count or leukopenia with WBC \<4500/mm\^3
3. Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study within 48 hours before the first dose of study drug
4. PORT risk class of II to V (PSI score \>50)
5. Must be a suitable candidate for possible IV to oral switch antibiotic therapy and must also be able to swallow large tablets/capsules intact without crushing
Exclusion Criteria
2. Any infection expected to require other systemic antibiotics in addition to study drug
3. Receipt of systemic antibiotic therapy in the 7 days before enrollment unless 1 of the following is documented:
* Received at least 48 hours of antibiotic therapy for CABP and clinic notes document treatment failure (i.e., not by patient history or pulmonary imaging alone) with new or worsening symptoms while on pre-study therapy
* Received 1 dose of a single, potentially effective, short-acting antibacterial drug or drug regimen for CABP within 24 hours before enrollment (limited to 25% of enrolled patients)
4. Respiratory infection confirmed or suspected to be secondary to hospital-acquired or ventilator-associated pneumonia OR requires treatment in an intensive care setting, OR requires mechanical ventilation
5. Current or suspected diagnosis of viral, fungal, or aspiration pneumonia, noninfectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis, empyema (not including sterile parapneumonic effusions)
6. Known anatomical or pathological bronchial obstruction OR history of bronchiectasis OR GOLD Stage 4 COPD OR history of post obstructive pneumonia
7. Severely compromised immune system
8. Known history of Child-Pugh Class B or C liver disease
9. History of post-antibiotic colitis within last 3 months
10. Other exclusions include those described in the safety label for drugs in the quinolone and/or oxazolidinone classes such as QT prolongation, proarrhythmic conditions, concomitant use of drugs known to cause QT prolongation, peripheral neuropathy, tendon disorders, history of myasthenia gravis, liver disease, severe renal disease, seizures and concomitant use of MAO A or B inhibitor agents and adrenergic serotonergic agents
18 Years
ALL
No
Sponsors
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Melinta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sue Cammarata, MD
Role: STUDY_DIRECTOR
Melinta Therapeutics, Inc.
Locations
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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
Melinta 306 Study Site
Baltimore, Maryland, United States
Melinta 306 Study Site
Boston, Massachusetts, United States
Melinta 306 Study Site
Burlington, Massachusetts, United States
Melinta 306 Study Site
Saint Paul, Minnesota, United States
Melinta 306 Study Site
St Louis, Missouri, United States
Melinta 306 Study Site
Butte, Montana, United States
Melinta 306 Study Site
Omaha, Nebraska, United States
Melinta 306 Study Site
Newark, New Jersey, United States
Melinta 306 Study Site
Buffalo, New York, United States
Melinta 306 Study Site
Charlotte, North Carolina, United States
Melinta 306 Study Site
Cleveland, Ohio, United States
Melinta 306 Study Site
Dayton, Ohio, United States
Melinta 306 Study Site
Rapid City, South Dakota, United States
Melinta 306 Study Site
Franklin, Tennessee, United States
Melinta 306 Study Site
Corsicana, Texas, United States
Melinta 306 Study Site
Buenos Aires, , Argentina
Melinta 306 Study Site
Córdoba, , Argentina
Melinta 306 Study Site
La Plata, , Argentina
Melinta 306 Study Site
Pleven, , Bulgaria
Melinta 306 Study Site
Rousse, , Bulgaria
Melinta 306 Study Site
Sofia, , Bulgaria
Melinta 306 Study Site
Stara Zagora, , Bulgaria
Melinta 306 Study Site
Barranquilla, , Colombia
Melinta 306 Study Site
Cali, , Colombia
Melinta 306 Study Site
Manizales, , Colombia
Melinta 306 Study Site
Medellín, , Colombia
Melinta 306 Study Site
Quindío, , Colombia
Melinta 306 Study Site
Santo Domingo, , Dominican Republic
Melinta 306 Study Site
Tbilisi, , Georgia
Melinta 306 Study Site
Leverkusen, , Germany
Melinta 306 Study Site
Munich, , Germany
Melinta 306 Study Site
Budapest, , Hungary
Melinta 306 Study Site
Debrecen, , Hungary
Melinta 306 Study Site
Deszk, , Hungary
Melinta 306 Study Site
Miskolc, , Hungary
Melinta 306 Study Site
Nyíregyháza, , Hungary
Melinta 306 Study Site
Szombathely, , Hungary
Melinta 306 Study Site
Daugavpils, , Latvia
Melinta 306 Study Site
Liepāja, , Latvia
Melinta 306 Study Site
Riga, , Latvia
Melinta 306 Study Site
Lima, , Peru
Melinta 306 Study Site
Chrzanów, , Poland
Melinta 306 Study Site
Katowice, , Poland
Melinta 306 Study Site
Lodz, , Poland
Melinta 306 Study Site
Wroclaw, , Poland
Melinta 306 Study Site
Brasov, , Romania
Melinta 306 Study Site
Bucharest, , Romania
Melinta 306 Study Site
Craiova, , Romania
Melinta 306 Study Site
Timișoara, , Romania
Melinta 306 Study Site
Arkhangelsk, , Russia
Melinta 306 Study Site
Moscow, , Russia
Melinta 306 Study Site
Saint Petersburg, , Russia
Melinta 306 Study Site
Smolensk, , Russia
Melinta 306 Study Site
Vsevolozhsk, , Russia
Melinta 306 Study Site
Belgrade, , Serbia
Melinta 306 Study Site
Kamenitz, , Serbia
Melinta 306 Study Site
Kragujevac, , Serbia
Melinta 306 Study Site
Niš, , Serbia
Melinta 306 Study Site
Golnik, , Slovenia
Melinta 306 Study Site
Ljubljana, , Slovenia
Melinta 306 Study Site
Benoni, , South Africa
Melinta 306 Study Site
Chatsworth, , South Africa
Melinta 306 Study Site
Krugersdorp, , South Africa
Melinta 306 Study Site
Middelburg, , South Africa
Melinta 306 Study Site
Phoenix, , South Africa
Melinta 306 Study Site
Port Elizabeth, , South Africa
Melinta 306 Study Site
Pretoria, , South Africa
Melinta 306 Study Site
Worcester, , South Africa
Melinta 306 Study Site
Badalona, , Spain
Melinta 306 Study Site
Barcelona, , Spain
Melinta 306 Study Site
Madrid, , Spain
Melinta 306 Study Site
Terrassa, , Spain
Melinta 306 Study Site
Valencia, , Spain
Melinta 306 Study Site
Dnipro, , Ukraine
Melinta 306 Study Site
Kharkiv, , Ukraine
Melinta 306 Study Site
Kyiv, , Ukraine
Melinta 306 Study Site
Poltava, , Ukraine
Melinta 306 Study Site
Vinnytsia, , Ukraine
Melinta 306 Study Site
Zaporizhia, , Ukraine
Melinta 306 Study Site
Zhytomyr, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003026-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML-3341-306
Identifier Type: -
Identifier Source: org_study_id
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