Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia

NCT01198626 | Terminated Phase 2

• 1 other identifier: 32729463CAP2001
• Study Type: interventional
• Target: 32
• Locations: 6 countries
• Sites: 34

Brief Summary

The purpose of this study is to determine the efficacy, safety and tolerability of JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring hospitalization for Community-Acquired Bacterial Pneumonia (CABP).

Conditions

Community-Acquired Bacterial Pneumonia (CABP)

Keywords

community-acquired bacterial pneumonia; CABP; CAP; pneumonia; pneumonia, bacterial; bacterial infections; anti-bacterial agents; anti-infective agents; lung disease, interstitial; respiratory tract diseases; respiratory tract infections; community-acquired infections

Outcome Measures

Primary Outcomes (1)

• Resolution of signs and symptoms of community-acquired bacterial pneumonia

  Day 19 (Test of Cure Visit)

Secondary Outcomes (7)

• Daily signs and symptoms of CABP

  Up to Day 19

• Microbiological response: per-pathogen and per-subject

  Day 19 (Test of Cure Visit)

• Percent of subjects with resolution of signs and symptoms of CABP

  Day 3 and Day 4

• Clinical outcome in subjects with S. pneumoniae

  Day 19 (Test of Cure Visit)

• Rate of superinfections or new infections

  Day 30

Study Arms (3)

JNJ-32729463

EXPERIMENTAL

Drug: JNJ-32729463

moxifloxacin

ACTIVE COMPARATOR

Drug: moxifloxacin

JNJ-32729463 Open-Label

EXPERIMENTAL

subjects with suspected or confirmed S. aureus CABP may be entered into an open-label JNJ 32729463 treatment group at selected study sites

Drug: JNJ-32729463 (Open-Label)

Interventions

JNJ-32729463 DRUG

150 mg intravenous formulation administered twice daily for at least 72 hours, followed by 250 mg oral formulation administered twice daily for a total treatment time of 7 to 14 days

JNJ-32729463

moxifloxacin DRUG

400 mg intravenous formulation administered once daily for at least 72 hours, followed by 400 mg oral formulation administered once daily for a total treatment time of 7 to 14 days. To maintain the blind, subjects will receive one dose of moxifloxacin and one dose of placebo daily.

Also known as: Avelox

moxifloxacin

JNJ-32729463 (Open-Label) DRUG

Subjects may receive JNJ-32729463 intravenous formulation up to 150 mg either BID or TID followed by 250 mg oral formulation BID for a total treatment time of 7 to 14 days.

JNJ-32729463 Open-Label

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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).

Sponsors & Collaborators

• Furiex Pharmaceuticals, Inc: lead

Study Sites (34)

Furiex Research Site

Mobile, Alabama, 36608, United States

Location

Furiex Research Site

Sylmar, California, 91342, United States

Location

Furiex Research Site

Orlando, Florida, 32837, United States

Location

Furiex Research Site

Vero Beach, Florida, 32960, United States

Location

Furiex Research Site

Peoria, Illinois, 61637, United States

Location

Furiex Research Site

Hazard, Kentucky, 41701, United States

Location

Furiex Research Site

Anaconda, Montana, 59711, United States

Location

Furiex Research Site

Omaha, Nebraska, 68131, United States

Location

Furiex Research Site

Albueuerque, New Mexico, 87131, United States

Location

Furiex Research Site

Austin, Texas, 78701, United States

Location

Furiex Research Site

Austin, Texas, 78705, United States

Location

Furiex Research Site

Austin, Texas, 78759, United States

Location

Furiex Research Site

Longview, Washington, 98632, United States

Location

Furiex Research Site

Calgary, Alberta, T2N 4N2, Canada

Location

Furiex Research Site

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Furiex Research Site

Québec, Quebec, G1V 4G5, Canada

Location

Furiex Research Site

Bogotá, Colombia

Location

Furiex Research Site

Cali, Colombia

Location

Furiex Research Site

Greifswald, 17475, Germany

Location

Furiex Research Site

Hanover, 30625, Germany

Location

Furiex Research Site

Hofheim, 65719, Germany

Location

Furiex Research Site

Homburg/Saar, 66421, Germany

Location

Furiex Research Site

Paderborn, 33098, Germany

Location

Furiex Research Site

Csorna, 9300, Hungary

Location

Furiex Research Site

Debrecen, 4043, Hungary

Location

Furiex Research Site

Gyöngyös, 3200, Hungary

Location

Furiex Research Site

Miskolc, 3529, Hungary

Location

Furiex Research Site

Tatabánya, 2800, Hungary

Location

Furiex Research Site

Bialystok, 15-276, Poland

Location

Furiex Research Site

Bydgoszcz, 85-681, Poland

Location

Furiex Research Site

Bystra, 43-360, Poland

Location

Furiex Research Site

Lodz, 90-153, Poland

Location

Furiex Research Site

Skierniewice, 96-100, Poland

Location

Furiex Research Site

Warsaw, 03-401, Poland

Location

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial; Bacterial Infections; Lung Diseases, Interstitial; Respiratory Tract Diseases; Respiratory Tract Infections; Community-Acquired Infections

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Infections; Lung Diseases; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 10, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

DE (5); PL (6); US (13); HU (5); CO (2); CA (3)