Efficacy and Safety Study of JNJ-32729463 Compared With M... | NCT01198626

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

NCT01198626

Sponsor

Furiex Pharmaceuticals, Inc

Status

Terminated

Last Update Posted

Dec 8, 2011Estimated

Enrollment

32Actual

Phase

Phase 2

Conditions

Community-Acquired Bacterial Pneumonia (CABP)

Interventions

JNJ-32729463
moxifloxacin
JNJ-32729463 (Open-Label)

Countries

United States
Canada
Colombia
Germany
Hungary
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment would not have been met prior to the end of the pneumonia season. Termination is based on slow enrollment and not related to safety or efficacy.

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Sep 7, 2010

First Submission Date that Met QC Criteria

Sep 9, 2010

First Posted Date

Sep 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 5, 2011

Certification/Extension First Submitted that Passed QC Review

Dec 5, 2011

Certification/Extension First Posted Date

Dec 8, 2011Estimated

Last Update Submitted Date

Dec 5, 2011

Last Update Posted Date

Dec 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of signs and symptoms of community-acquired bacterial pneumonia		Day 19 (Test of Cure Visit)

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Furiex Research Site		Mobile	Alabama	36608	United States
Furiex Research Site

ID	Term
D011014	Pneumonia
D018410	Pneumonia, Bacterial
D001424	Bacterial Infections
D017563	Lung Diseases, Interstitial
D012140	Respiratory Tract Diseases
D012141	Respiratory Tract Infections
D017714	Community-Acquired Infections

ID	Term
D007239	Infections
D008171	Lung Diseases
D001423	Bacterial Infections and Mycoses

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds