Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia

NCT01081964 | Terminated Phase 2

• 1 other identifier: PB-101-200
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Community Acquired Pneumonia

Keywords

pneumonia; Community acquired pneumonia of moderate severity

Outcome Measures

Primary Outcomes (1)

• Safety

  Assess safety through monitoring of adverse events, ECGs, and the collection of conventional laboratory data (i.e., chemistry panel, CBC with differential, urinalysis)

  Up to 35 days after first dose

Secondary Outcomes (1)

• Efficacy of the two dosing regimens of zabofloxacin

  Up to 35 days after first dose

Study Arms (3)

Levofloxacin 500mg

ACTIVE COMPARATOR

Levofloxacin 500mg once daily for 7 days

Drug: Levofloxacin 500mg

Zabofloxacin 5 days

EXPERIMENTAL

Zabofloxacin 400mg for 5 days

Drug: Zabofloxacin 400mg

Zabofloxacin 3 days

EXPERIMENTAL

Zabofloxacin 400mg for 3 days

Drug: Zabofloxacin

Interventions

Zabofloxacin DRUG

Zabofloxacin 400mg capsule once daily for 3 days

Zabofloxacin 3 days

Levofloxacin 500mg DRUG

Levofloxacin 500mg orally for 7 days

Levofloxacin 500mg

Zabofloxacin 400mg DRUG

Zabofloxacin 400mg orally for 5 days

Zabofloxacin 5 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• new or increased cough
• production of purulent sputum or a change in the character of sputum in subjects who normally have purulent sputum
• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• IASO Pharma Inc.: lead

Study Sites (13)

Unknown Facility

Huntsville, Alabama, 35801, United States

Location

Unknown Facility

Toney, Alabama, 35773, United States

Location

Unknown Facility

Fort Myers, Florida, 33916, United States

Location

Unknown Facility

Eagle, Idaho, 93616, United States

Location

Unknown Facility

Evansville, Indiana, 47714, United States

Location

Unknown Facility

Keego Harbor, Michigan, 48320, United States

Location

Unknown Facility

Belvidere, New Jersey, 078238, United States

Location

Unknown Facility

Columbus, Ohio, 43214, United States

Location

Unknown Facility

Dayton, Ohio, 45432, United States

Location

Unknown Facility

Springfield, Ohio, 45504, United States

Location

Unknown Facility

Gresham, Oregon, 97030, United States

Location

Unknown Facility

Warminster, Pennsylvania, 18974, United States

Location

Unknown Facility

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Interventions

zabofloxacin; Levofloxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: March 5, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

US (13)