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
- Registration Number
- PER-035-11
- Lead Sponsor
- FURIEX PHARMACEUTICALS, INC,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
1. SUBJECT IS MALE OR FEMALE BETWEEN THE AGE OF 18 AND 85 YEARS, INCLUSIVE.
2. IF THE SUBJECT IS FENALE 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. SUBJECTS HAS CABP REQUIRING HOSPITALIZATION WITH A PORTH 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 (I00.4°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 MULTILOBULAR DISTRIBUTION CHARACTERISTIC OB BACTERIAL PNEUMONIA. SUBJECTS WITH THE PRESENCE OF NECROTIZING LESIONS CHARACTERITIC OF S. AUREUS PNEUMONIA ARE ELIGIBLE FOR ENROLLMENT IN THE OPEN-LABEL JNJ-32729463 TREATMENT ARM FOR S. AUREUS PNEUMONIA.
1. SUBJECT IS INTUBATED AT THE TIME OF CONSENT OR SUBJECT IS A CANDIDATE FOR ENROLLMENT INTO THE OPEN-LABEL TREATMENT 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. SUBJECTS HAS MILD CABP WITH A PORT SCORE OF LESS THAN II.
3. THE PATIENT HAS RECEIVED ANY SYSTEMIC ANTIBIOTIC IN THE LAST 96 HOURS BEFORE THE RANDOMIZATION, UNLESS:
A. BE PATIENT HIV NEGATIVE AND HAVE RECEIVED TREATMENT FOR RESPIRATORY INFECTION WITH ANY ANTIBIOTIC, A FLUOROQUINOLONE EXCEPT FOR A COURSE OF TREATMENT> 48 HOURS AND <6 DAYS, AND GATHER THE CLINICAL FAILURE FOLLOWING CRITERIA:
I. THE GRAM STAIN SAMPLE SPUTUM LESS THAN 10 SQUAMOUS EPITHELIAL CELLS AND POLYMORPHONUCLEAR CELLS OVER 25 FOR LOW POWER FIELD (100X MAGNIFICATION) AND MICRO PREDOMINANT L0 LEAST 1 NBAC CONSISTENT WITH, AND
II.THE PATIENT AT LEAST ONE OF THE FOLLOWING:
1)ADVANCE NBAC SYMPTOMS
2)SYMPTOM DEVELOPMENT NEW / ADDITIONAL NBAC
3)DEVELOPMENT OF NEW DISCOVERIES / ADDITIONAL IN CHEST RADIOGRAPHY WITH CONSEQUENTIAL NBAC.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method