A Randomized, Controlled, Double-Blind, Multicenter, Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia (CABP) With a PORT Score of II or Greater

• Conditions: Community-Acquired Bacterial Pneumonia (CABP)

• Registration Number: EUCTR2010-021574-11-HU
• Lead Sponsor: Furiex Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

To be eligible for enrollment in this study, each of the following criteria must be satisfied with a YES answer (unless not applicable):
1 Subject is male or female between the ages of 18 and 75 yrs, inclusive.
2 If the subject is female and of childbearing potential, the subject agrees to use an acceptable form of contraception. Acceptable forms of contraception for subject or partner include condoms with spermicide gel, diaphragm with spermicide gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depot progesterone injections, and abstinence.
3 Subject has CABP requiring hospitalization with a PORT score of II or greater.
4 Subject has 3 or more of the following clinical signs and symptoms:
a Cough with production of purulent sputum
b Dyspnea or tachypnea
c Chest pain
d Fever or hypothermia
i Fever is defined as body temperature >38°C (100.4°F) taken orally, >38.5°C (101.3°F) tympanically, or >39°C (102.2°F) rectally.
ii Hypothermia is defined as body temperature <35°C (95°F).
e Clinical findings of pulmonary consolidation (eg, dullness on percussion, bronchial breath sounds, or egophony)
5 Subject’s chest x ray shows the presence of new infiltrates in a lobar or multilobar distribution characteristic of bacterial pneumonia. Subjects with the presence of necrotizing lesions characteristic of S. aureus pneumonia are eligible for enrollment in the open-label JNJ 32729463 treatment arm for S. aureus pneumonia.
6 Subject is able to generate an adequate sputum specimen. An adequate sputum specimen is a specimen that has fewer than 10 squamous epithelial cells and more than 25 polymorphonuclear cells per low-power field (100× magnification). Respiratory secretions may be obtained by any of the following means:
a deep expectoration
b bronchoscopy with bronchoalveolar lavage or protected-brush sampling
7 Subject or legally authorized representative, is able to provide written and voluntary informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To be eligible for this study, each of the following criteria must be satisfied with a NO answer:
1 Subject intubated at randomization OR subject is a candidate for enrollment into the open-label S. aureus arm and has been intubated >12 hrs prior to randomization. (This does not exclude subjects who require positive-pressure breathing, such as continuous positive airway pressure or bilevel positive airway pressure)
2 Subject has mild CABP with a PORT score of less than II
3 Subject has received any systemic antibiotics within the last 2 wks before randomization
PRIOR ANTIBIOTIC USE: In general, subjects who have received any prior antibiotics within the past 2 wks before randomization SHOULD NOT BE ENROLLED. However, recognizing current standards of care, if one is unable to initiate study medication infusion in an acceptable time frame, subjects are eligible for enrollment if, by standard of care, they have received a single dose of a single short acting antibiotic within 12 hrs prior to randomization
4 Subject has received ceftriaxone, azithromycin, any fluoroquinolone or doxycycline (these are not considered to be short-acting antibiotics) or any long acting antibiotic defined as an antibiotic with >8 hr plasma half-life within the last 2 wks before randomization
5 Subject has an infection that necessitates the use of a concomitant antibacterial agent in addition to study medication; the use of topical agents is allowed
6 Subject has viral, fungal, mycobacterial, or atypical pneumonia. A subject who has tested positive for influenza virus >5 days prior to study entry, who has clinically worsened, and whose chest radiograph is now consistent with a new infiltrate suspicious for bacterial pneumonia (including small necrotizing abscesses characteristic of S. aureus pneumonia) may be entered in the open-label JNJ 32729463 treatment arm for S. aureus pneumonia
7 Subject has pneumonia suspected to be secondary to aspiration
8 Subject has primary, solitary lung abscess. Small, multiple, necrotizing abscesses suspicious for S. aureus pneumonia may be entered into the open-label JNJ 32729463 treatment arm for S. aureus pneumonia
9 Subject has healthcare-associated pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia or subject has been hospitalized for greater than 72 hrs for any reason 30 days before randomization (excluding the 24 hr period before enrollment)
10 Subject has known bronchial obstruction or a history of postobstructive pneumonia. (This does not exclude subjects who have COPD)
11 Subject has primary lung cancer or another malignancy metastatic to the lungs
12 Subject is receiving or has received chemotherapeutic agents within the past 3 mths
13 Subject has cystic fibrosis, known or suspected Pneumocystis jiroveci (carinii) pneumonia, or known or suspected active tuberculosis
14 In the past 4 wks before randomization, the subject has shown clinically significant disease of immune function (eg, current CD4 <200, current neutrophil count <1000/µL). Subjects with human immunodeficiency virus are allowed if they have a CD4 count >200 at Baseline
15 Subject has received systemic steroids at a dose =10 mg/day of prednisone (or its equivalent) or other chronic immunosuppressive therapy such as disease-modifying antirheumatic drugs or interferons within the 6 weeks before Baseline. Subjects on current treatment with (or with a history of prior treatment with) inhaled steroids are not excluded from this study
16 S

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified