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

Purpose

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

Condition	Intervention	Phase
Community-acquired Bacterial Pneumonia	Drug: Solithromycin Drug: Moxifloxacin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Cempra Pharmaceuticals:

Primary Outcome Measures:

Early clinical response rate in the Intent to Treat (ITT) population [ Time Frame: 72 [±12] hours after the first dose of study drug ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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 oral solithromycin compared to oral moxifloxacin in the mITT population
Clinical success rates in the ITT and Clincally 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 oral solithromycin compared to moxifloxacin

Estimated Enrollment:	860
Study Start Date:	December 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Solithromycin Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7	Drug: Solithromycin Other Name: CEM-101
Active Comparator: Moxifloxacin Moxifloxacin 400 mg PO daily on Day 1 through Day 7	Drug: Moxifloxacin Other Name: Avelox

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756339

Contacts

Contact: Kay Clark, RN

kclark@cempra.com

Show 67 Study Locations

Sponsors and Collaborators

Cempra Pharmaceuticals

More Information

No publications provided

Responsible Party:	Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01756339 History of Changes
Other Study ID Numbers:	CE01-300
Study First Received:	December 20, 2012
Last Updated:	May 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cempra Pharmaceuticals:

Pneumonia
CABP
CAP
Macrolide

Additional relevant MeSH terms:

Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013