A clinical study of the safety and effectiveness of JNJ 32729463 compared with Moxifloxacin for the treatment of patients requiring hospitalization for Community-Acquired Bacterial Pneumonia (CABP)

• Conditions: Community-Acquired Bacterial Pneumonia (CABP); MedDRA version: 13.1Level: LLTClassification code 10004051Term: Bacterial pneumonia, unspecifiedSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2010-021574-11-DE
• Lead Sponsor: Furiex Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-18
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Subject is male or female between the ages of 18 and 85 years, inclusive.
2. If the subject is female and of childbearing potential, the subject agrees to use an acceptable form of contraception. Acceptable forms of contraception for subject or partner include condoms with spermicide gel, diaphragm with spermicide gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depot progesterone injections, and abstinence.
3. Subject has CABP requiring hospitalization with a PORT score of II or greater (Appendix 3).
4. Subject has 3 or more of the following clinical signs and symptoms:
a. Cough with production of purulent sputum
b. Dyspnea or tachypnea
c. Chest pain
d. Fever or hypothermia
i. Fever is defined as body temperature >38°C (100.4°F) taken orally, >38.5°C (101.3°F) tympanically, or >39°C (102.2°F) rectally.
ii. Hypothermia is defined as body temperature <35°C (95°F).
e. Clinical findings of pulmonary consolidation (eg, dullness on percussion, bronchial breath sounds, or egophony)
5. Subject’s chest x ray shows the presence of new infiltrates in a lobar or multilobar distribution characteristic of bacterial pneumonia. Subjects with the presence of necrotizing lesions characteristic of S. aureus pneumonia are eligible for enrollment in the open-label JNJ 32729463 treatment arm for S. aureus pneumonia.
6. Subject is able to generate an adequate sputum specimen. An adequate sputum specimen is a specimen that has fewer than 10 squamous epithelial cells and more than 25 polymorphonuclear cells per low power field (100× magnification). Respiratory secretions may be obtained by any of the following means:
a. deep expectoration
b. bronchoscopy with bronchoalveolar lavage or protected-brush sampling
7. Subject, or legally authorized representative, is able to provide written and voluntary informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Subject is 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. (This does not exclude subjects who require positive-pressure breathing, such as continuous positive airway pressure or bilevel positive airway pressure. Also, patients who require intubation after randomization may remain in the study.)
2. Subject has mild CABP with a PORT score of less than II.
3. Subject has received any systemic antibiotics within the last 96 hours before randomization, unless:
a. Subject is HIV negative and received treatment for a respiratory infection with any antibiotic, EXCEPT a fluoroquinolone, for a treatment course > 48 hours and < 6 days, and meets the following criteria for clinical failure:
i. Sputum gram stain shows fewer than 10 squamous epithelial cells and more than 25 polymorphonuclear cells per low-power field (100× magnification) and at least 1 predominant microorganism consistent with CABP; &
ii. Subject has at least one of the following:
- Progression of symptoms of CABP
- Development of new/additional symptoms of CABP
- Development of new/additional chest x-ray findings consistent with CABP
These subjects are NOT eligible for enrollment if they test positive for influenza at Baseline via rapid test. Subjects previously treated with a fluoroquinolone are not eligible for enrollment even if they meet the criteria for clinical failure.
b. Recognizing current standards of care, if one is unable to initiate study medication infusion in an acceptable time frame, subjects are eligible for enrollment if, by standard of care, they have received a single dose of a single short-acting (defined as an antibiotic with <8 hour plasma half-life) antibiotic, or ceftriaxone, within 24 hours prior to randomization. Subjects who receive azithromycin, any fluoroquinolone, or doxycycline within 96 hours prior to randomization are NOT eligible for enrollment (these are not considered to be short-acting antibiotics).
4. Subject has an infection that necessitates the use of a concomitant antibacterial agent in addition to study medication; the use of topical agents is allowed.
5. Subject has viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis. However:
a. A subject who tests positive for influenza via rapid test at Baseline is eligible for enrollment if the subject has simultaneous suspected CABP demonstrated by the predominance of a bacterial organism consistent with CABP on sputum Gram Stain.
b. A subject who has tested positive for influenza virus >5 days prior to study entry, who has clinically worsened, and whose chest radiograph is now consistent with a new infiltrate suspicious for bacterial pneumonia (including small necrotizing abscesses characteristic of S. aureus pneumonia) may be entered in the open-label JNJ 32729463 treatment arm for S. aureus pneumonia.
6. Subject has pneumonia suspected to be secondary to aspiration.
7. Subject has primary, solitary lung abscess. Small, multiple, necrotizing abscesses suspicious for S. aureus pneumonia may be entered into the open-label JNJ 32729463 treatment arm for S. aureus pneumonia.
8. Subject has healthcare-associated pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia or subject has been hospitalized for greater than 72 hours for any reason 30 days before randomization (excluding the 24 hour period before enrollment).
9. Subje

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified