Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia

This study has been terminated.
(Financial considerations)
Sponsor:
Information provided by (Responsible Party):
IASO Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01081964
First received: February 19, 2010
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

A double-blind, three-arm study, to evaluate the safety and efficacy of two dosing regimens of zabofloxacin (a fluoroquinolone antibiotic) in community acquired pneumonia.


Condition Intervention Phase
Community Acquired Pneumonia
Drug: Zabofloxacin
Drug: Levofloxacin 500mg
Drug: Zabofloxacin 400mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Dose, Double-Blind, Double-Dummy, Active-Control, Randomized Study to Evaluate the Safety, Efficacy and Pharmacokinetic Profile of Two Dosing Regimens of Zabofloxacin for the Treatment of Community-Acquired Pneumonia of Moderate Severity

Resource links provided by NLM:


Further study details as provided by IASO Pharma Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 35 days after first dose ] [ Designated as safety issue: Yes ]
    Assess safety through monitoring of adverse events, ECGs, and the collection of conventional laboratory data (i.e., chemistry panel, CBC with differential, urinalysis)


Secondary Outcome Measures:
  • Efficacy of the two dosing regimens of zabofloxacin [ Time Frame: Up to 35 days after first dose ] [ Designated as safety issue: No ]
    Determine the clinical response and microbiological response of two dosing regimens in the treatment of bacteriologically confirmed CAP of moderate severity; determine the pharmacokinetic profile in subjects with CAP.


Enrollment: 48
Study Start Date: March 2010
Estimated Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levofloxacin 500mg
Levofloxacin 500mg once daily for 7 days
Drug: Levofloxacin 500mg
Levofloxacin 500mg orally for 7 days
Experimental: Zabofloxacin 5 days
Zabofloxacin 400mg for 5 days
Drug: Zabofloxacin 400mg
Zabofloxacin 400mg orally for 5 days
Experimental: Zabofloxacin 3 days
Zabofloxacin 400mg for 3 days
Drug: Zabofloxacin
Zabofloxacin 400mg capsule once daily for 3 days

Detailed Description:

The study is a Phase 2, global, prospective, multi-dose, double-blind, double-dummy, active-control, randomized, parallel-group, multicenter study of oral zabofloxacin HCl (400mg) versus oral levofloxacin (500mg) in the treatment of adults with community-acquired pneumonia of moderate severity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female >/= 18 years old
  • Documented fever (oral >100°F (37.8°C), tympanic >101°F (38.1°C)must be documented within the time frame of 24 hours prior to first dose through 24 hours after first dose of study drug
  • Community-acquired pneumonia of moderate severity (defined as PSI Risk Class II or III) requiring administration of antibiotics
  • Dyspnea and/or tachypnea (>20 breaths/minute)
  • Clinical diagnosis of pneumonia, as demonstrated by all of the following signs and symptoms:

    1. new or increased cough
    2. production of purulent sputum or a change in the character of sputum in subjects who normally have purulent sputum
    3. auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (e.g., bronchial breath sounds, egophony, or dullness on percussion)
  • Females must be surgically sterile (e.g., tubal ligation, hysterectomy), post-menopausal at least 2 years, or if of childbearing potential, they must have a negative urine pregnancy test (β-human chorionic gonadotropin [β-hCG]) prior to randomization into the study. Males and females must agree that if they have intercourse that they will use at least two medically accepted methods of birth control (e.g., hormonal contraceptive, intrauterine device, spermicide, or condom) from study entry through 60 days after discontinuation of study drug treatment
  • Able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Committee and comply with the requirements of the study

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

  • Received one or more doses of any systemic antibiotic in the last 2 weeks
  • Diagnosed with any other infection requiring systemic antibacterial therapy
  • Require long-term (>7 days) antibiotic therapy
  • Previous diagnosed condition that might mimic or complicate the course and evaluation of the infectious disease process (e.g., septic shock, bronchiectasis, lung abcess or empyema, aspiration pneumonia, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia, etc.)
  • Hypothermia (oral <96°F [35.6°C}, tympanic <97°F [35.9°C]
  • Hospitalization (inpatient) in the previous 60 days or infection presumably acquired in the hospital
  • Resident of a skilled nursing facility anytime in the previous 60 days or infection presumably acquired in a skilled nursing facility
  • Chronic infection with Hepatitis B
  • Any evidence of, or is a known carrier of , Hepatitis C antibody
  • Infection with Clostridium difficile
  • Immunocompromising illness, including known human immunodeficiency virus (HIV) positivity or AIDS, organ (bone marrow) transplant recipients, and hematological malignancy
  • Psychotic disease, peripheral neuropathy, and glucose-6-phosphate dehydrogenase deficiency; uncontrolled or poorly controlled diabetes. Diabetic subjects who are stable and on a stable course of antihyperglycemic agents for the past 3 months will be permitted in the trial.
  • High exposure to sunlight or ultraviolet radiation
  • Immunosuppressive therapy, including cancer chemotherapy or chronic use of corticosteroids (i.e., >20mg prednisone or equivalent per day for >/= 14 days within the last 6 months
  • History of renal or hepatic disease as defined by at least one of the following:

    1. Calculated creatinine clearance <50 mL/min (any subject on dialysis must be excluded)
    2. BUN >/= 30 mg/dL
    3. ALT or AST > 3x ULN
    4. Total bilirubin > 2x ULN
    5. Alkaline phosphatase > 1.25x ULN
  • History of or current malabsorption conditions (i.e., short bowel syndrome, active Crohn's disease, celiac disease, etc.)
  • Neutropenia as defined by absolute neutrophil count <1000 cells/mm3. Subjects with neutrophil counts as low as 500 cells/mm3 are permitted if the reduction can be documented to be due to the acute infectious process
  • Platelet count <75,000/mm3. Subjects with platelet counts as low as 50,000/mm3 are permitted if the reduction is historically stable
  • Coagulation tests >1.5x ULN (PT, PTT, or INR). Subjects on anticoagulants with values > 1.5x ULN can be enrolled, provided these values are historically stable and within the therapeutic range
  • History of alcohol or drug abuse in the past 2 years
  • History of seizure or currently receiving anti-seizure medication anytime in the past year, or a seizure in the past year
  • History of ventricular arrhythmia
  • History of QTc prolongation (i.e., >450msec) or observed QTc measurement at screening > 450msec, or a history of additional risk factors for Torsade de Pointe, such as heart failure, hypokalemia, or familial history of Long QT syndrome
  • Require medications that may prolong the QTc interval
  • Require medications that affect absorption, including but not limited to sucralfate or cimetidine
  • Require treatment with theophylline, probenecid, vitamin K antagonists (other than warfarin; subjects must be on stable dose of warfarin and within therapeutic range)
  • Pregnant, planning to become pregnant, or breast feeding
  • Received any investigational drug or device within 30 days prior to study entry
  • Previously received zabofloxacin in a clinical trial
  • History of allergy or intolerability to fluoroquinolones
  • History of fluoroquinolone tendinopathy
  • Evidence of immediately life-threatening disease including, but not limited to current or impending respiratory failure, acute heart failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive emergency, acute hepatic failure, active gastrointestinal bleeding, profound metabolic abnormalities (e.g., diabetic ketoacidosis), or acute cerebrovascular events
  • Current condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data
  • Unable or unwilling to adhere to sthe study specified procedures and restrictions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081964

Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
Toney, Alabama, United States, 35773
United States, Florida
Ft. Myers, Florida, United States, 33916
United States, Idaho
Eagle, Idaho, United States, 93616
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Michigan
Keego Harbor, Michigan, United States, 48320
United States, New Jersey
Belvidere, New Jersey, United States, 078238
United States, Ohio
Columbus, Ohio, United States, 43214
Dayton, Ohio, United States, 45432
Springfield, Ohio, United States, 45504
United States, Oregon
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Warminster, Pennsylvania, United States, 18974
United States, Texas
Tyler, Texas, United States, 75708
Sponsors and Collaborators
IASO Pharma Inc.
  More Information

No publications provided

Responsible Party: IASO Pharma Inc.
ClinicalTrials.gov Identifier: NCT01081964     History of Changes
Other Study ID Numbers: PB-101-200
Study First Received: February 19, 2010
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by IASO Pharma Inc.:
pneumonia
Community acquired pneumonia of moderate severity

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Levofloxacin
Ofloxacin
Fluoroquinolones
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014