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

Information source: Cempra Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Community-acquired Bacterial Pneumonia

Intervention: Solithromycin (Drug); Moxifloxacin (Drug); Placebo to match solithromycin (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Cempra Pharmaceuticals

Official(s) and/or principal investigator(s):
David Oldach, MD, Study Director, Affiliation: Cempra Pharmaceuticals


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

Clinical Details

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

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

Primary outcome: Early clinical response rate in the Intent to Treat (ITT) population

Secondary outcome:

Early clinical response rate in the microITT population

Clinical success rates in the ITT and Clincally Evaluable (CE) populations

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Caba C1120AAF, Argentina

Ciudad Autonoma de Buenos Aires 1426, Argentina

Ciudad Autonoma de Buenos Aires C1425BEA, Argentina

Cordoba X5000JRD, Argentina

Santa Fe S3000EOZ, Argentina

Pernik 2300, Bulgaria

Ruse 7002, Bulgaria

Sofia 1709, Bulgaria

Sofia 1336, Bulgaria

Sofia 1431, Bulgaria

Sofia 1233, Bulgaria

Beroun 266 01, Czech Republic

Santo Domingo 10205, Dominican Republic

Santo Domingo 10511, Dominican Republic

Guayaquil, Ecuador

Quito, Ecuador

Tallinn 13619, Estonia

Tallinn 10617, Estonia

Tartu 51014, Estonia

Hannover 30173, Germany

Budapest 1121, Hungary

Budapest 1122, Hungary

Budapest 1125, Hungary

Kecskemet 6000, Hungary

Nyiregyhaza 4400, Hungary

Daugavpils LV5417, Latvia

Liepaja LV 3414, Latvia

Riga LV-1002, Latvia

Riga LV-1057, Latvia

Krakow 31011, Poland

Lodz 90153, Poland

Lublin 20090, Poland

Zgierz 95100, Poland

San Juan 00921, Puerto Rico

Bucharest 030303, Romania

Bucharest 010825, Romania

Bucharest 021659, Romania

Craiova 200515, Romania

Iasi 700115, Romania

Timisoara 300310, Romania

Chelyabinsk 454008, Russian Federation

Moscow 109240, Russian Federation

Moscow 111539, Russian Federation

Moscow 115446, Russian Federation

Moscow 125284, Russian Federation

Moscow 123182, Russian Federation

Moscow 125206, Russian Federation

Moscow 119991, Russian Federation

Smolensk 214019, Russian Federation

St Petersburg 193312, Russian Federation

St. Petersburg 194354, Russian Federation

St. Petersburg 195271, Russian Federation

St. Petersburg 196247, Russian Federation

St. Petersburg 197022, Russian Federation

St. Petersburg 199106, Russian Federation

St. Petersburg 192242, Russian Federation

Benoni 1500, South Africa

Bloemfontein 9300, South Africa

Cape Town 7530, South Africa

Cape Town 7570, South Africa

Cape Town 7764, South Africa

Krugersdorp 1739, South Africa

Pretoria 0001, South Africa

Worcester 6850, South Africa

Barcelona 08036, Spain

Madrid 28046, Spain

Madrid 28850, Spain

Mataro 08304, Spain

Valencia 46026, Spain

Edmonton, Alberta T6G 2B7, Canada

Badalona, Barcelona 08916, Spain

Vancouver, British Columbia V1Y 1S1, Canada

La Plata, Buenos Aires B1900AVG, Argentina

Tandil, Buenos Aires B7000AXD, Argentina

Glendale, California 91206, United States

Los Angeles, California 90015, United States

Mission Hills, California 91345, United States

Oxnard, California 93030, United States

Pasadena, California 91105, United States

Sylmar, California 91342, United States

Torrance, California 90502, United States

Hofheim, De-he 65719, Germany

Rotenburg (Wuemme), De-ni 27356, Germany

Debary, Florida 32713, United States

DeLand, Florida 32720, United States

Miami, Florida 33144, United States

Miami, Florida 33126, United States

St Cloud, Florida 34769, United States

Tampa, Florida 33606, United States

Duluth, Georgia 30096, United States

Guayaquil, Guayas EC090103, Ecuador

St Petersburg, Leningrad Region 198205, Russian Federation

St Petersburg, Leningrad Region 196211, Russian Federation

St Petersburg, Leningrad Region 194354, Russian Federation

Thabazimbi, Limpopo 0380, South Africa

Majadahonda, Madrid 28222, Spain

New Bedford, Massachusetts 02740, United States

Halfway House, Midrand 1685, South Africa

Butte, Montana 59701, United States

Middelburg, Mpumalanga 1055, South Africa

Witbank, Mpumalanga 1035, South Africa

Columbus, Ohio 43035, United States

Cornwall, Ontario K6H 4M4, Canada

Downingtown, Pennsylvania 19335, United States

Korsten, Port Elizabeth 6014, South Africa

Hillcrest, Pretoria 0083, South Africa

Loma Hermosa, Provincia de Buenos Aires B1657BHD, Argentina

Montreal, Quebec H1T 2M4, Canada

Rosario, Santa Fe S2000CVB, Argentina

Smolensk, Smolensk Region 214019, Russian Federation

Summerville, South Carolina 29485, United States

Rapid City, South Dakota 57702, United States

Houston, Texas 77011, United States

Houston, Texas 77030, United States

Houston, Texas 77070, United States

Houston, Texas 77093, United States

Splendora, Texas 77372, United States

San Miguel De Tucuman, Tucuman T4000IAR, Argentina

Additional Information

Starting date: December 2012
Last updated: December 3, 2014

Page last updated: August 23, 2015

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