Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Furiex Pharmaceuticals, Inc
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
women of childbearing potential must agree to use an acceptable method of birth control
clinical diagnosis of community acquired bacterial pneumonia (CABP)
PORT score of II or greater
able to generate an adequate sputum specimen
chest x-ray showing presence of new infiltrates in a lobar or multilobar distribution characteristic of bacterial pneumonia
You may not be if
history of tendon damage/disorders due to quinolone therapy
uncorrected hypokalemia
history of myasthenia gravis
intubated at the time of consent OR subject is a candidate for enrollment into the open-label S. aureus arm and has been intubated greater than 12 hours prior to randomization
mild CABP with a PORT score of less than II
viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis
pneumonia suspected to be secondary to aspiration
primary, solitary lung abscess
healthcare-associated pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
known bronchial obstruction or a history of postobstructive pneumonia.
primary lung cancer or another malignancy metastatic to the lungs
cystic fibrosis, known or suspected Pneumocystis jiroveci (carinii) pneumonia, or known or suspected active tuberculosis
infection that necessitates the use of a concomitant antibacterial agent in addition to study medication
systemic antibiotics within the last 96 hours before randomization, with exceptions
hospitalized for greater than 72 hours for any reason 30 days before randomization (excluding the 24 hour period before enrollment).
history of a serious hypersensitivity reaction to any quinolone including moxifloxacin.
female and pregnant, breastfeeding, or may be pregnant.
Other protocol-specific eligibility criteria may apply
Clareo Health | Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
