Community-Acquired Bacterial Pneumonia (CABP)Phase 2NCT01198626
Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
A Phase 2 study testing JNJ-32729463, moxifloxacin and JNJ-32729463 (Open-Label) in people with Community-Acquired Bacterial Pneumonia (CABP), run by Furiex Pharmaceuticals, Inc at 34 sites in 6 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Community-Acquired Bacterial Pneumonia (CABP)
- What is being tested?
- JNJ-32729463, moxifloxacin and JNJ-32729463 (Open-Label)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 34 sitesin 6 countries
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
United States13 sites
Furiex Research Site
Albueuerque, New Mexico, 87131
Furiex Research Site
Anaconda, Montana, 59711
Furiex Research Site
Austin, Texas, 78701
Furiex Research Site
Austin, Texas, 78705
Furiex Research Site
Austin, Texas, 78759
Furiex Research Site
Hazard, Kentucky, 41701
Furiex Research Site
Longview, Washington, 98632
Furiex Research Site
Mobile, Alabama, 36608
Furiex Research Site
Omaha, Nebraska, 68131
Furiex Research Site
Orlando, Florida, 32837
Furiex Research Site
Peoria, Illinois, 61637
Furiex Research Site
Sylmar, California, 91342
Furiex Research Site
Vero Beach, Florida, 32960
Poland6 sites
Furiex Research Site
Bialystok, 15-276
Furiex Research Site
Bydgoszcz, 85-681
Furiex Research Site
Bystra, 43-360
Furiex Research Site
Lodz, 90-153
Furiex Research Site
Skierniewice, 96-100
Furiex Research Site
Warsaw, 03-401
Germany5 sites
Furiex Research Site
Greifswald, 17475
Furiex Research Site
Hanover, 30625
Furiex Research Site
Hofheim, 65719
Furiex Research Site
Homburg/Saar, 66421
Furiex Research Site
Paderborn, 33098
Hungary5 sites
Furiex Research Site
Csorna, 9300
Furiex Research Site
Debrecen, 4043
Furiex Research Site
Gyöngyös, 3200
Furiex Research Site
Miskolc, 3529
Furiex Research Site
Tatabánya, 2800
Canada3 sites
Furiex Research Site
Calgary, Alberta, T2N 4N2
Furiex Research Site
Chicoutimi, Quebec, G7H 5H6
Furiex Research Site
Québec, Quebec, G1V 4G5
About this study
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
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).
- Being tested
- JNJ-32729463, moxifloxacin, JNJ-32729463 (Open-Label)
- 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
- Medical subject headings
- Pneumonia, Pneumonia, Bacterial, Bacterial Infections, Lung Diseases, Interstitial, Respiratory Tract Diseases, Respiratory Tract Infections, Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-32729463Drug
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
moxifloxacinDrug
Also called Avelox
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)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.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-32729463 | Experimental | Not described Receives: Drug: JNJ-32729463 |
| moxifloxacin | Active comparator | Not described Receives: 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 Receives: Drug: JNJ-32729463 (Open-Label) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of signs and symptoms of community-acquired bacterial pneumonia
Measured: Day 19 (Test of Cure Visit)
Secondary outcomes (7)
Daily signs and symptoms of CABP
Measured: Up to Day 19
Microbiological response: per-pathogen and per-subject
Measured: Day 19 (Test of Cure Visit)
Percent of subjects with resolution of signs and symptoms of CABP
Measured: Day 3 and Day 4
Clinical outcome in subjects with S. pneumoniae
Measured: Day 19 (Test of Cure Visit)
Rate of superinfections or new infections
Measured: Day 30
Time to oral switch
Measured: Day 14
All-cause mortality
Measured: Up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired Bacterial Pneumonia (CABP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Furiex Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198626
- Sponsor's protocol ID
- 32729463CAP2001
- Status last verified
- Dec 2011
- First submitted
- 7 Sep 2010
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01198626
- Acronym / sponsor ID
- 32729463CAP2001
- Keywords
- community-acquired bacterial pneumonia, CABP, CAP, pneumonia, pneumonia, bacterial, bacterial infections, anti-bacterial agents, anti-infective agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Furiex Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JNJ-32729463 | Experimental | Drug: JNJ-32729463 |
| moxifloxacin | Active comparator | Drug: moxifloxacin |
| JNJ-32729463 Open-Label | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-32729463150 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 | Drug | JNJ-32729463 |
| moxifloxacinAlso: Avelox400 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. | Drug | moxifloxacin |
| 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. | Drug | JNJ-32729463 Open-Label |
Primary outcome
Resolution of signs and symptoms of community-acquired bacterial pneumonia
Time frame: Day 19 (Test of Cure Visit)
7 secondary outcomes
Daily signs and symptoms of CABP
Time frame: Up to Day 19
Microbiological response: per-pathogen and per-subject
Time frame: Day 19 (Test of Cure Visit)
Percent of subjects with resolution of signs and symptoms of CABP
Time frame: Day 3 and Day 4
Clinical outcome in subjects with S. pneumoniae
Time frame: Day 19 (Test of Cure Visit)
Rate of superinfections or new infections
Time frame: Day 30
Time to oral switch
Time frame: Day 14
All-cause mortality
Time frame: Up to Day 30
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-32729463, moxifloxacin and JNJ-32729463 (Open-Label) in people with Community-Acquired Bacterial Pneumonia (CABP), run by Furiex Pharmaceuticals, Inc at 34 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Poland, Germany, Hungary, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of signs and symptoms of community-acquired bacterial pneumonia (time frame: Day 19 (Test of Cure Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.