| Status | Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
|---|---|---|---|---|---|
| Active | CE01-301 | 2013-003453-13 | NCT01968733 |
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
Purpose / Objectives
Primary Outcome
To determine noninferiority (NI) in early clinical response rate (defined as improvement at 72 [±12] hours after the first dose of study drug), in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production, (without worsening of any) of intravenous (IV) to oral solithromycin compared to IV to oral moxifloxacin in adult patients with community-acquired bacterial pneumonia (CABP) in the Intent to Treat (ITT) population.
Secondary Outcomes
- Early clinical response rate in the microITT population [ Time Frame: 72 [±12] hours after the first dose of study drug ] [ Designated as safety issue: No ]
To determine NI in early clinical response rate of intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population
- Clinical success rates in the ITT and Clinically Evaluable (CE) populations [ Time Frame: 5 to 10 days after the last dose of study drug ] [ Designated as safety issue: No ]
To determine the overall clinical success rates of intravenous to oral solithromycin compared to moxifloxacin
Diagnosis
- Bacterial Pneumonia
Target population
Age
18-99
Study design
- Phase III
- Multicenter
- Double-blind
- Randomized
Intervention
Drug: Solithromycin
Drug: Moxifloxacin
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