Status:
COMPLETED
Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
Lead Sponsor:
Melinta Therapeutics, Inc.
Conditions:
Community-Acquired Bacterial Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
Community-acquired bacterial pneumonia is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergenc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01168713
Start Date
August 1 2010
End Date
July 1 2011
Last Update
March 3 2017
Active Locations (55)
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1
Birmingham, Alabama, United States, 35242
2
Flagstaff, Arizona, United States, 86001
3
Bell Gardens, California, United States, 90201
4
Chula Vista, California, United States, 91911