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

Community-Acquired Bacterial Pneumonia (CABP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01198626
• Other study ID #: 32729463CAP2001
• Status: Terminated
• Phase: Phase 2
• First received: September 7, 2010
• Last updated: December 5, 2011
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: Furiex Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHungary: National Institute of PharmacyPoland: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-Acquired Bacterial Pneumonia (CABP)
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• JNJ-32729463
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
• moxifloxacin
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.
• JNJ-32729463 (Open-Label)
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.

Locations

Country	Name	City	State
Canada	Furiex Research Site	Calgary	Alberta
Canada	Furiex Research Site	Chicoutimi	Quebec
Canada	Furiex Research Site	Quebec
Colombia	Furiex Research Site	Bogota
Colombia	Furiex Research Site	Cali
Germany	Furiex Research Site	Greifswald
Germany	Furiex Research Site	Hannover
Germany	Furiex Research Site	Hofheim
Germany	Furiex Research Site	Homburg/Saar
Germany	Furiex Research Site	Paderborn
Hungary	Furiex Research Site	Csorna
Hungary	Furiex Research Site	Debrecen
Hungary	Furiex Research Site	Gyongyos
Hungary	Furiex Research Site	Miskolc
Hungary	Furiex Research Site	Tatabanya
Poland	Furiex Research Site	Bialystok
Poland	Furiex Research Site	Bydgoszcz
Poland	Furiex Research Site	Bystra
Poland	Furiex Research Site	Lodz
Poland	Furiex Research Site	Skierniewice
Poland	Furiex Research Site	Warszawa
United States	Furiex Research Site	Albueuerque	New Mexico
United States	Furiex Research Site	Anaconda	Montana
United States	Furiex Research Site	Austin	Texas
United States	Furiex Research Site	Austin	Texas
United States	Furiex Research Site	Austin	Texas
United States	Furiex Research Site	Hazard	Kentucky
United States	Furiex Research Site	Longview	Washington
United States	Furiex Research Site	Mobile	Alabama
United States	Furiex Research Site	Omaha	Nebraska
United States	Furiex Research Site	Orlando	Florida
United States	Furiex Research Site	Peoria	Illinois
United States	Furiex Research Site	Sylmar	California
United States	Furiex Research Site	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Furiex Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of signs and symptoms of community-acquired bacterial pneumonia		Day 19 (Test of Cure Visit)	No
Secondary	Daily signs and symptoms of CABP		Up to Day 19	No
Secondary	Microbiological response: per-pathogen and per-subject		Day 19 (Test of Cure Visit)	No
Secondary	Percent of subjects with resolution of signs and symptoms of CABP		Day 3 and Day 4	No
Secondary	Clinical outcome in subjects with S. pneumoniae		Day 19 (Test of Cure Visit)	No
Secondary	Rate of superinfections or new infections		Day 30	No
Secondary	Time to oral switch		Day 14	No
Secondary	All-cause mortality		Up to Day 30	No