Community Acquired Pneumonia
Conditions
Keywords
pneumonia, Community acquired pneumonia of moderate severity
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.
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.
Interventions
DRUGZabofloxacin
Zabofloxacin 400mg capsule once daily for 3 days
Levofloxacin 500mg orally for 7 days
DRUGZabofloxacin 400mg
Zabofloxacin 400mg orally for 5 days
Sponsors
IASO Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed