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

Community-acquired Bacterial Pneumonia Clinical Trial

— SOLITAIRE-ORAL  

Official title:

A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756339
• Other study ID #: CE01-300
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2012
• Last updated: March 1, 2017
• Start date: December 2012
• Est. completion date: October 2014

Study information

• Verified date: March 2017
• Source: Cempra Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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):

1. Cough

2. Production of purulent sputum

3. Shortness of breath (dyspnea)

4. Chest pain due to pneumonia

• At least 1 of the following:

1. Fever

2. Hypothermia

3. 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

Exclusion Criteria:

• 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:

1. Viral or fungal pneumonia

2. Pneumocystis jiroveci pneumonia

3. Aspiration pneumonia

4. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)

5. Primary or metastatic lung cancer

6. Cystic fibrosis

7. Active or suspected tuberculosis

• Known HIV or myasthesia gravis

Related Conditions & MeSH terms

• Community-acquired Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Solithromycin

• Moxifloxacin

Other:
• Placebo to match solithromycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cempra Inc

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Czech Republic,  Dominican Republic,  Ecuador,  Estonia,  Germany,  Hungary,  Latvia,  Poland,  Puerto Rico,  Romania,  Russian Federation,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early clinical response rate in the Intent to Treat (ITT) population	To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.	72 [±12] hours after the first dose of study drug
Secondary	Early clinical response rate in the microITT population	To determine NI in early clinical response rate of oral solithromycin compared to oral moxifloxacin in the mITT population	72 [±12] hours after the first dose of study drug
Secondary	Clinical success rates in the ITT and Clincally Evaluable (CE) populations	To determine the overall clinical success rates of oral solithromycin compared to moxifloxacin	5 to 10 days after the last dose of study drug