A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.
Inclusion Criteria:
Male and female patients ≥ 18 years of age
An acute onset of at least 3 of the following signs and symptoms (new or worsening):
At least 1 of the following:
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
Exclusion Criteria:
Bethleham, Pennsylvania 18015, United States
Caba, Buenos Aires C1093AAS, Argentina
Florencia Varela, Buenos Aires B1887FWB, Argentina
Cheras, Kuala Lumpur 56000, Malaysia
Jalan Pahang, Kuala Lumpur 50586, Malaysia
Ampang, Selangor 68000, Malaysia
Cercado, Lima 1 Lima 1, Peru
Cercado, Lima Lima01, Peru
EDSA Caloocan City, National Capital Region 1400, Philippines
Kosice-Saca, Slovakia 04015, Slovakia
Middleburg, Mpumalanga 1055, South Africa
Seoul, Gyeonggi-do 136-705, South Korea
Seoul, Gyeonggi-do 143-729, South Korea
Seoul, Gyeonggi-do 150-950, South Korea
Changhua Country, 500, Taiwan
Ivano Frakivsk, 76018, Ukraine