Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral CEM-101 Compared to Oral Levofloxacin in the Treatment of Patients With Community-Acquired Bacterial Pneumonia
1 other identifier
interventional
132
2 countries
55
Brief Summary
Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2010
Shorter than P25 for phase_2
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMarch 3, 2017
March 1, 2017
11 months
July 22, 2010
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit
Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
5 to 10 days after the last dose of study drug
Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit
Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
5 to 10 days after the last dose of study drug
Secondary Outcomes (14)
By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT)
5 days of study drug treatment
By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit
5 to 10 days after the last dose of study drug
By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT)
5 days of study drug treatment
By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit
5 to 10 days after the last dose of study drug
Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT)
5 days of study drug treatment
- +9 more secondary outcomes
Study Arms (2)
Levofloxacin
ACTIVE COMPARATORCEM-101
EXPERIMENTALInterventions
Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5
CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5
Eligibility Criteria
You may qualify if:
- Diagnosis of community acquired bacterial pneumonia (e.g. cough with purulent sputum or change in character of sputum consistent with bacterial infection, dyspnea or tachypnea, chest pain due to pneumonia, fever, presence of rales and/or signs of consolidation).
- No prior systemic antibacterial therapy, unless failed other therapy.
- Chest Xray shows new lobar or multilobar infiltrate(s) consistent with acute bacterial pneumonia.
- PORT Risk Class II, III, or IV \<=105
- Ability to take oral medication.
You may not qualify if:
- Severe chronic obstructive pulmonary disease FEV1 \<30%.
- Hospitalization within 90 days or residence in a long-term-care facility within 30 days prior to the onset of symptoms
- Chemotherapy or radiation therapy within the previous 3 months.
- Significant hepatic, hematological, renal abnormalities.
- Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g. life expectancy \<30 days).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Unknown Facility
Birmingham, Alabama, 35242, United States
Unknown Facility
Flagstaff, Arizona, 86001, United States
Unknown Facility
Bell Gardens, California, 90201, United States
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
LeMesa, California, 91942, United States
Unknown Facility
Los Angeles, California, 90015, United States
Unknown Facility
Montclaire, California, 91763, United States
Unknown Facility
Norwalk, California, 90650, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Oxnard, California, 93030, United States
Unknown Facility
Pasadena, California, 91105, United States
Unknown Facility
Torrence, California, 90501, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
DeBary, Florida, 32713, United States
Unknown Facility
Gainesville, Florida, 32605, United States
Unknown Facility
Hialeah, Florida, 33012, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Orlando, Florida, 32837, United States
Unknown Facility
Blue Ridge, Georgia, 30513, United States
Unknown Facility
Columbus, Georgia, 31904, United States
Unknown Facility
Savannah, Georgia, 31406, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Morton, Illinois, 61550, United States
Unknown Facility
Dubuque, Iowa, 52001, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Fall River, Massachusetts, 02720, United States
Unknown Facility
New Bedford, Massachusetts, 02740, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Traverse City, Michigan, 49684, United States
Unknown Facility
Butte, Montana, 59701, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Akron, Ohio, 44304, United States
Unknown Facility
Carlisle, Ohio, 45005, United States
Unknown Facility
Eugene, Oregon, 97404, United States
Unknown Facility
West Reading, Pennsylvania, 19611, United States
Unknown Facility
Simpsonville, South Carolina, 29681, United States
Unknown Facility
Rapid City, South Dakota, 57702, United States
Unknown Facility
Franklin, Tennessee, 37067, United States
Unknown Facility
Corsicana, Texas, 75110, United States
Unknown Facility
Houston, Texas, 77002, United States
Unknown Facility
Houston, Texas, 77093, United States
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San Antonio, Texas, 78238, United States
Unknown Facility
Draper, Utah, 84020, United States
Unknown Facility
Magna, Utah, 84044, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Calgary, Alberta, T2N2T9, Canada
Unknown Facility
Hamilton, Ontario, L8N3Z5, Canada
Unknown Facility
Hamilton, Ontario, L8N4A6, Canada
Unknown Facility
Hamilton, Ontario, L8V1C3, Canada
Unknown Facility
Ottawa, Ontario, K1Y 4E9, Canada
Unknown Facility
Toronto, Ontario, M9W 4L6, Canada
Unknown Facility
Chicoutimi, Quebec, G7H-5H6, Canada
Unknown Facility
Saint-Jérôme, Quebec, J7Z5T3, Canada
Unknown Facility
Sherbrooke, Quebec, J1H5N4, Canada
Unknown Facility
Trios-Rivieres, Quebec, G8Z3R9, Canada
Related Publications (1)
Oldach D, Clark K, Schranz J, Das A, Craft JC, Scott D, Jamieson BD, Fernandes P. Randomized, double-blind, multicenter phase 2 study comparing the efficacy and safety of oral solithromycin (CEM-101) to those of oral levofloxacin in the treatment of patients with community-acquired bacterial pneumonia. Antimicrob Agents Chemother. 2013 Jun;57(6):2526-34. doi: 10.1128/AAC.00197-13. Epub 2013 Mar 18.
PMID: 23507282DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 23, 2010
Study Start
August 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
March 3, 2017
Record last verified: 2017-03