Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Completed · Phase 3 · Has a placebo group

Conditions studied: Community-acquired Bacterial Pneumonia

In brief

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Key facts

Study ID

NCT01756339

Run by

Melinta Therapeutics, Inc.

People needed

860

Starts

2012-12-01

Expected to finish

2014-10-01

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…

• Male and female patients ≥ 18 years of age
• An acute onset of at least 3 of the following signs and symptoms (new or worsening):
• Cough
• Production of purulent sputum
• Shortness of breath (dyspnea)
• Chest pain due to pneumonia
• At least 1 of the following:
• Fever
• Hypothermia
• Presence of pulmonary rales and/or evidence of pulmonary consolidation
• PORT Risk Class II, III, or IV
• Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study
• Not received any systemic antibiotics during the prior 7 days

You may not qualify if…

• Ventilator-associated pneumonia
• Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease
• Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms
• Presence of known:
• Viral or fungal pneumonia
• Pneumocystis jiroveci pneumonia
• Aspiration pneumonia
• Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)
• Primary or metastatic lung cancer
• Cystic fibrosis
• Active or suspected tuberculosis
• Known HIV or myasthesia gravis

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Mission Hills, California, United States
• Study site — Oxnard, California, United States
• Study site — Pasadena, California, United States
• Study site — Sylmar, California, United States
• Study site — Torrance, California, United States
• Study site — DeBary, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Saint Cloud, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Duluth, Georgia, United States
• Study site — New Bedford, Massachusetts, United States
• Study site — Butte, Montana, United States
• Study site — Columbus, Ohio, United States
• Study site — Downingtown, Pennsylvania, United States
• Study site — Summerville, South Carolina, United States
• Study site — Rapid City, South Dakota, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Splendora, Texas, United States
• Study site — Glendale, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.