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

Sponsor

Furiex Pharmaceuticals, Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT01198626

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

0.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Community-Acquired Bacterial Pneumonia (CABP)	Drug: JNJ-32729463 Drug: moxifloxacin Drug: JNJ-32729463 (Open-Label)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-32729463	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
Active Comparator: moxifloxacin	Drug: 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. Other Names: Avelox
Experimental: JNJ-32729463 Open-Label 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) 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.

Arm

Intervention/Treatment

Experimental: JNJ-32729463

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

Active Comparator: moxifloxacin

Drug: 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.

Other Names:

Avelox

Experimental: JNJ-32729463 Open-Label

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)

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.

Outcome Measures

Primary Outcome Measures

Resolution of signs and symptoms of community-acquired bacterial pneumonia [Day 19 (Test of Cure Visit)]

Secondary Outcome Measures

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]
Time to oral switch [Day 14]
All-cause mortality [Up to Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Furiex Research Site	Mobile	Alabama	United States	36608
2	Furiex Research Site	Sylmar	California	United States	91342
3	Furiex Research Site	Orlando	Florida	United States	32837
4	Furiex Research Site	Vero Beach	Florida	United States	32960
5	Furiex Research Site	Peoria	Illinois	United States	61637
6	Furiex Research Site	Hazard	Kentucky	United States	41701
7	Furiex Research Site	Anaconda	Montana	United States	59711
8	Furiex Research Site	Omaha	Nebraska	United States	68131
9	Furiex Research Site	Albueuerque	New Mexico	United States	87131
10	Furiex Research Site	Austin	Texas	United States	78701
11	Furiex Research Site	Austin	Texas	United States	78705
12	Furiex Research Site	Austin	Texas	United States	78759
13	Furiex Research Site	Longview	Washington	United States	98632
14	Furiex Research Site	Calgary	Alberta	Canada	T2N 4N2
15	Furiex Research Site	Chicoutimi	Quebec	Canada	G7H 5H6
16	Furiex Research Site	Quebec		Canada	G1V 4G5
17	Furiex Research Site	Bogota		Colombia
18	Furiex Research Site	Cali		Colombia
19	Furiex Research Site	Greifswald		Germany	17475
20	Furiex Research Site	Hannover		Germany	30625
21	Furiex Research Site	Hofheim		Germany	65719
22	Furiex Research Site	Homburg/Saar		Germany	66421
23	Furiex Research Site	Paderborn		Germany	33098
24	Furiex Research Site	Csorna		Hungary	9300
25	Furiex Research Site	Debrecen		Hungary	4043
26	Furiex Research Site	Gyongyos		Hungary	3200
27	Furiex Research Site	Miskolc		Hungary	3529
28	Furiex Research Site	Tatabanya		Hungary	2800
29	Furiex Research Site	Bialystok		Poland	15-276
30	Furiex Research Site	Bydgoszcz		Poland	85-681
31	Furiex Research Site	Bystra		Poland	43-360
32	Furiex Research Site	Lodz		Poland	90-153
33	Furiex Research Site	Skierniewice		Poland	96-100
34	Furiex Research Site	Warszawa		Poland	03-401