Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia

• Sponsor: IASO Pharma Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01081964
• Collaborator: (none)
• Enrollment: 48
• Locations: 13
• Arms: 3
• Duration (Months): 27
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Community Acquired Pneumonia	Drug: Zabofloxacin; Drug: Levofloxacin 500mg; Drug: Zabofloxacin 400mg	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Apr 1, 2012
• Anticipated Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Safety [Up to 35 days after first dose]

   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

1. Efficacy of the two dosing regimens of zabofloxacin [Up to 35 days after first dose]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Locations

	Site	City	State	Country	Postal Code
1		Huntsville	Alabama	United States	35801
2		Toney	Alabama	United States	35773
3		Ft. Myers	Florida	United States	33916
4		Eagle	Idaho	United States	93616
5		Evansville	Indiana	United States	47714
6		Keego Harbor	Michigan	United States	48320
7		Belvidere	New Jersey	United States	078238
8		Columbus	Ohio	United States	43214
9		Dayton	Ohio	United States	45432
10		Springfield	Ohio	United States	45504
11		Gresham	Oregon	United States	97030
12		Warminster	Pennsylvania	United States	18974
13		Tyler	Texas	United States	75708

Sponsors and Collaborators

• IASO Pharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IASO Pharma Inc.
• ClinicalTrials.gov Identifier: NCT01081964
• Other Study ID Numbers: PB-101-200
• First Posted: Mar 5, 2010
• Last Update Posted: May 7, 2012
• Last Verified: May 1, 2012

• Keywords provided by IASO Pharma Inc.: pneumonia; Community acquired pneumonia of moderate severity
• Additional relevant MeSH terms: Pneumonia; Levofloxacin; Ofloxacin; Fluoroquinolones

Study Results

No Results Posted as of May 7, 2012