Randomized, double-blind, multicenter phase 2 study comparing the efficacy and
safety of oral solithromycin (CEM-101) to those of oral levofloxacin in the
treatment of patients with community-acquired bacterial pneumonia.
Author(s): Oldach D(1), Clark K, Schranz J, Das A, Craft JC, Scott D, Jamieson BD, Fernandes
P.
Affiliation(s): Author information:
(1)Cempra Inc, Chapel Hill, North Carolina, USA.
Publication date & source: 2013, Antimicrob Agents Chemother. , 57(6):2526-34
Solithromycin, a new macrolide, and the first fluoroketolide in clinical
development, with activity against macrolide-resistant bacteria, was tested in
132 patients with moderate to moderately severe community-acquired bacterial
pneumonia (CABP) in a multicenter, double-blind, randomized phase 2 study.
Patients were enrolled and randomized (1:1) to either 800 mg solithromycin orally
(PO) on day 1, followed by 400 mg PO daily on days 2 to 5, or 750 mg levofloxacin
PO daily on days 1 to 5. Efficacy outcome rates of clinical success at the
test-of-cure visit 4 to 11 days after the last dose of study drug were comparable
in the intent-to-treat (ITT) (84.6% for solithromycin versus 86.6% for
levofloxacin) and microbiological-intent-to-treat (micro-ITT) (77.8% for
solithromycin versus 71.4% for levofloxacin) populations. Early response success
rates at day 3, defined as improvement in at least two cardinal symptoms of
pneumonia, were also comparable (72.3% for solithromycin versus 71.6% for
levofloxacin). More patients treated with levofloxacin than with solithromycin
experienced treatment-emergent adverse events (TEAEs) during the study (45.6%
versus 29.7%). The majority of TEAEs were mild or moderate gastrointestinal
symptoms and included nausea (1.6% for solithromycin; 10.3% for levofloxacin),
diarrhea (7.8% for solithromycin; 5.9% for levofloxacin), and vomiting (0% for
solithromycin; 4.4% for levofloxacin). Six patients, all of whom received
levofloxacin, discontinued the study drug due to an adverse event. Solithromycin
demonstrated comparable efficacy and favorable safety relative to levofloxacin.
These findings support a phase 3 study of solithromycin for the treatment of
CABP. (This study has been registered at ClinicalTrials.gov under registration
no. NCT01168713.).
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