Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Completed · Phase 2

Conditions studied: Community-Acquired Bacterial Pneumonia

In brief

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.

Key facts

Study ID

NCT01168713

Run by

Melinta Therapeutics, Inc.

People needed

132

Starts

2010-08-01

Expected to finish

2011-07-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Study site — Flagstaff, Arizona, United States
• Study site — Bell Gardens, California, United States
• Study site — Chula Vista, California, United States
• Study site — LeMesa, California, United States
• Study site — Los Angeles, California, United States
• Study site — Montclaire, California, United States
• Study site — Norwalk, California, United States
• Study site — Oceanside, California, United States
• Study site — Oxnard, California, United States
• Study site — Pasadena, California, United States
• Study site — Torrence, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — DeBary, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Blue Ridge, Georgia, United States
• Study site — Columbus, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Morton, Illinois, United States
• Study site — Dubuque, Iowa, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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