Community Acquired PneumoniaPhase 2NCT01081964
Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia
A Phase 2 study testing Zabofloxacin, Levofloxacin 500mg and Zabofloxacin 400mg in people with Community Acquired Pneumonia, run by IASO Pharma Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Zabofloxacin, Levofloxacin 500mg and Zabofloxacin 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2010to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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]
Show all 40Show fewer
- 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:
- Calculated creatinine clearance <50 mL/min (any subject on dialysis must be excluded)
- BUN >/= 30 mg/dL
- ALT or AST > 3x ULN
- Total bilirubin > 2x ULN
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Belvidere, New Jersey, 078238
Study site
Columbus, Ohio, 43214
Study site
Dayton, Ohio, 45432
Study site
Eagle, Idaho, 93616
Study site
Evansville, Indiana, 47714
Study site
Fort Myers, Florida, 33916
Study site
Gresham, Oregon, 97030
Study site
Huntsville, Alabama, 35801
Study site
Keego Harbor, Michigan, 48320
Study site
Springfield, Ohio, 45504
Study site
Toney, Alabama, 35773
Study site
Tyler, Texas, 75708
Study site
Warminster, Pennsylvania, 18974
About this study
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
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.
Read the 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.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Zabofloxacin, Levofloxacin 500mg, Zabofloxacin 400mg
- Keywords
- pneumonia, Community acquired pneumonia of moderate severity
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZabofloxacinDrug
Zabofloxacin 400mg capsule once daily for 3 days
Levofloxacin 500mgDrug
Levofloxacin 500mg orally for 7 days
Zabofloxacin 400mgDrug
Zabofloxacin 400mg orally for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin 500mg | Active comparator | Levofloxacin 500mg once daily for 7 days Receives: Drug: Levofloxacin 500mg |
| Zabofloxacin 5 days | Experimental | Zabofloxacin 400mg for 5 days Receives: Drug: Zabofloxacin 400mg |
| Zabofloxacin 3 days | Experimental | Zabofloxacin 400mg for 3 days Receives: Drug: Zabofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Assess safety through monitoring of adverse events, ECGs, and the collection of conventional laboratory data (i.e., chemistry panel, CBC with differential, urinalysis)
Measured: Up to 35 days after first dose
Secondary outcomes (1)
Efficacy of the two dosing regimens of zabofloxacin
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.
Measured: Up to 35 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2012
- Study completionJun 2012 (estimated)
Why it stopped: Financial considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- IASO Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081964
- Sponsor's protocol ID
- PB-101-200
- Status last verified
- May 2012
- First submitted
- 19 Feb 2010
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01081964
- Acronym / sponsor ID
- PB-101-200
- Conditions
- Community Acquired Pneumonia
- Keywords
- pneumonia, Community acquired pneumonia of moderate severity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial considerations
- Enrolment
- 48 participants (actual)
- Lead sponsor
- IASO Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (estimated)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin 500mg | Active comparator | Drug: Levofloxacin 500mgLevofloxacin 500mg once daily for 7 days |
| Zabofloxacin 5 days | Experimental | Drug: Zabofloxacin 400mgZabofloxacin 400mg for 5 days |
| Zabofloxacin 3 days | Experimental | Drug: ZabofloxacinZabofloxacin 400mg for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (40 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZabofloxacinZabofloxacin 400mg capsule once daily for 3 days | Drug | Zabofloxacin 3 days |
| Levofloxacin 500mgLevofloxacin 500mg orally for 7 days | Drug | Levofloxacin 500mg |
| Zabofloxacin 400mgZabofloxacin 400mg orally for 5 days | Drug | Zabofloxacin 5 days |
Primary outcome
Safety
Time frame: 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)
1 secondary outcome
Efficacy of the two dosing regimens of zabofloxacin
Time frame: Up to 35 days after first dose
Results and safety
The study was stopped early (reason given: Financial considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
Related trials for Community Acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zabofloxacin, Levofloxacin 500mg and Zabofloxacin 400mg in people with Community Acquired Pneumonia, run by IASO Pharma Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Financial considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Up to 35 days after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.