Community-Acquired Bacterial Pneumonia (CABP) MedDRA version: 13.1 Level: LLT Classification code 10004051 Term: Bacterial pneumonia, unspecified System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: JNJ-32729463 for Injection
Product Code: JNJ-32729463
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 1001162-01-1
Current Sponsor code: JNJ-32729463
Concentration unit
Sponsors
Furiex Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is male or female between the ages of 18 and 85 years, 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 (Appendix 3). 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 =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Subject is 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. (This does not exclude subjects who require positive-pressure breathing, such as continuous positive airway pressure or bilevel positive airway pressure. Also, patients who require intubation after randomization may remain in the study.) 2. Subject has mild CABP with a PORT score of less than II. 3. Subject has received any systemic antibiotics within the last 96 hours before randomization, unless: a. Subject is HIV negative and received treatment for a respiratory infection with any antibiotic, EXCEPT a fluoroquinolone, for a treatment course > 48 hours and 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. 6. Subject has pneumonia suspected to be secondary to aspiration. 7. 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. 8. Subject has healthcare-associated pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia or subject has been hospitalized for greater than 72 hours for any reason 30 days before randomization (excluding the 24 hour period before enrollment). 9. Subje
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate noninferiority in clinical success rates between JNJ 32729463 and moxifloxacin for subjects with CABP.;Secondary Objective: Treatment effect of JNJ 32729463 on daily signs & symptoms of CABP compared to moxifloxacin Treatment effect of JNJ 32729463 on % of subjects with resolution of signs & symptoms of CABP at Day 3 and Day 4 compared to moxifloxacin Treatment effect of JNJ 32729463 on per-pathogen microbiological response at TOC compared to moxifloxacin Treatment effect of JNJ 32729463 on per-subject microbiological response at TOC compared to moxifloxacin Treatment effect of JNJ 32729463 on clinical outcome at TOC compared to moxifloxacin in subjects with S. pneumoniae Treatment effect of JNJ 32729463 on rate of superinfections or new infections compared to moxifloxacin Treatment effect of JNJ 32729463 on time to oral switch compared to moxifloxacin All-cause mortality within 30 days of start of study medication Safety & tolerability profiles of JNJ 32729463 compared with those of moxifloxacin in subjects with CABP Evaluate AEs after treatment with JNJ 32729463 or moxifloxacin;Primary end point(s): The primary efficacy endpoint is subject clinical outcome based on complete resolution of signs and symptoms of CABP. The subject’s response to therapy will be based on a comparison of the subject’s baseline signs and symptoms and other laboratory parameters with the subject’s evaluation at the TOC visit.;Timepoint(s) of evaluation of this end point: TOC (non-inferiority) day 19 (approximately) from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Daily signs and symptoms of CABP 2. Percent of subjects with resolution of the signs and symptoms of CABP at Day 3 and Day 4 3. Per-pathogen microbiological response at TOC 4. Per-subject microbiological response at TOC 5. Clinical outcome at TOC in subjects with S. pneumoniae 6. Rate of superinfections or new infections 7. Time to oral switch 8. All-cause mortality within 30 days of start of study medication ;Timepoint(s) of evaluation of this end point: Stated in section E.5.2 TOC (non-inferiority) day 19 (approximately) from baseline Safety endpoints from baseline to day 30 (see protocol section 7.1 Appendix 1: Schedule of Study Procedures) | — |
Countries
Brazil, Bulgaria, Canada, Chile, Colombia, Germany, Hungary, Israel, Peru, Poland, Romania, Ukraine, United States
Contacts
Public ContactMarina Lefranc
PPD Ltd
Outcome results
None listed