Clinical Trial Details

NCT ID: NCT02679573
Date Last Changed: June 5, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Community Acquired Bacterial Pneumonia

Research Study Title

A Phase 3, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety and Efficacy of Intravenous to Oral Delafloxacin in Adult Subjects With Community-Acquired Bacterial Pneumonia

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Melinta Therapeutics, Inc.
Duration
22 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  1. Male or female 18 years of age or older

  2. Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening)

  3. Cough

  4. Production of purulent sputum consistent with bacterial infection

  5. Difficulty breathing

  6. 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

  • 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

  • PORT risk class of II to V (PSI score > 50)

  • 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:

  1. A medical history of significant hypersensitivity or allergic reaction to antibiotics of the quinolone or oxazolidinone class or study drug excipients according to the investigator

  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:

  4. 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

  5. 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)

  6. 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

  7. 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)

  8. Known anatomical or pathological bronchial obstruction OR history of bronchiectasis OR GOLD Stage 4 COPD OR history of post obstructive pneumonia

  9. Severely compromised immune system

  10. Known history of Child-Pugh Class B or C liver disease

  11. History of post-antibiotic colitis within last 3 months

  12. 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

Site Locations (59)

Country State City Zip Facility and Contact
United States Florida Coral Gables 33134 Melinta 306 Study Site
United States Florida DeBary 32713 Melinta 306 Study Site
United States Florida DeLand 32720 Melinta 306 Study Site
United States Florida Fort Myers 33901 Melinta 306 Study Site
United States Florida Miami 33126 Melinta 306 Study Site
United States Florida Miami 33185 Melinta 306 Study Site
United States Kentucky Louisville 40202 Melinta 306 Study Site
United States Maryland Baltimore 21201 Melinta 306 Study Site
United States Missouri Saint Louis 63110 Melinta 306 Study Site
United States Montana Butte 59701 Melinta 306 Study Site
United States Ohio Dayton 45402 Melinta 306 Study Site
United States South Dakota Rapid City 57702 Melinta 306 Study Site
United States Tennessee Franklin 37067 Melinta 306 Study Site
United States Texas Corsicana 75110 Melinta 306 Study Site
Bulgaria Pleven Melinta 306 Study Site
Bulgaria Ruse Melinta 306 Study Site
Bulgaria Sofia Melinta 306 Study Site
Bulgaria Stara Zagora Melinta 306 Study Site
Georgia Tbilisi Melinta 306 Study Site
Germany Leverkusen Melinta 306 Study Site
Germany Munich Melinta 306 Study Site
Hungary Budapest Melinta 306 Study Site
Hungary Deszk Melinta 306 Study Site
Hungary Miskolc Melinta 306 Study Site
Hungary Nyíregyháza Melinta 306 Study Site
Hungary Szombathely Melinta 306 Study Site
Latvia Daugavpils Melinta 306 Study Site
Latvia Liepaja Melinta 306 Study Site
Latvia Riga Melinta 306 Study Site
Poland Chrzanow Melinta 306 Study Site
Poland Katowice Melinta 306 Study Site
Poland Lodz Melinta 306 Study Site
Poland Wroclaw Melinta 306 Study Site
Romania Braşov Melinta 306 Study Site
Romania Bucharest Melinta 306 Study Site
Romania Craiova Melinta 306 Study Site
Russian Federation Arkhangel'sk Melinta 306 Study Site
Russian Federation Moscow Melinta 306 Study Site
Russian Federation Smolensk Melinta 306 Study Site
Russian Federation St. Petersburg Melinta 306 Study Site
Russian Federation Vsevolozhsk Melinta 306 Study Site
Serbia Belgrade Melinta 306 Study Site
Serbia Kragujevac Melinta 306 Study Site
Serbia Nis Melinta 306 Study Site
Serbia Sremska Kamenica Melinta 306 Study Site
Slovenia Golnik Melinta 306 Study Site
Slovenia Ljubljana Melinta 306 Study Site
South Africa Benoni Melinta 306 Study Site
South Africa Middelburg Melinta 306 Study Site
Spain Badalona Melinta 306 Study Site
Spain Barcelona Melinta 306 Study Site
Spain Madrid Melinta 306 Study Site
Spain Terrassa Melinta 306 Study Site
Spain Valencia Melinta 306 Study Site
Ukraine Kharkiv Melinta 306 Study Site
Ukraine Kyiv Melinta 306 Study Site
Ukraine Poltava Melinta 306 Study Site
Ukraine Vinnytsya Melinta 306 Study Site
Ukraine Zhytomyr Melinta 306 Study Site

Contact

Megan Quintas
312-724-9400
E-mail:

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