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

Completed · Phase 3

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

NCT01968733

Run by

Melinta Therapeutics, Inc.

People needed

863

Starts

2013-11-01

Expected to finish

2015-09-01

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
• Fungal pneumonia
• Pneumocystis jiroveci pneumonia
• Aspiration pneumonia
• Other non-infectious causes of pulmonary infiltrates
• Primary or metastatic lung cancer
• Cystic fibrosis
• Active or suspected tuberculosis
• HIV or myasthenia gravis

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Chino, California, United States
• Study site — Glendale, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — Sacramento, California, United States
• Study site — Sylmar, California, United States
• Study site — Torrance, California, United States
• Study site — Newark, Delaware, United States
• Study site — Bay Pines, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Doral, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Blue Ridge, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Council Bluffs, Iowa, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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