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

NCT ID: NCT01968733

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 863 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-09-30

Brief Summary

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

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.

Conditions

Community-acquired Bacterial Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Moxifloxacin

Intravenous with the potential step-down to oral moxifloxacin

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

Solithromycin

Intravenous with potential step-down to oral solithromycin

Group Type: EXPERIMENTAL

Solithromycin

Intervention Type: DRUG

Interventions

Solithromycin

Intervention Type: DRUG

Moxifloxacin

Intervention Type: DRUG

Other Intervention Names

CEM-101; Avelox

Eligibility 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
• Fungal pneumonia
• Pneumocystis jiroveci pneumonia
• Aspiration pneumonia
• Other non-infectious causes of pulmonary infiltrates
• Primary or metastatic lung cancer
• Cystic fibrosis
• Active or suspected tuberculosis
• HIV or myasthenia gravis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian D Jamieson, MD

Role: STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Locations

Mobile, Alabama, United States

Mobile, Alabama, United States

Little Rock, Arkansas, United States

Chino, California, United States

Glendale, California, United States

Laguna Hills, California, United States

Los Angeles, California, United States

Pasadena, California, United States

Sacramento, California, United States

Sylmar, California, United States

Torrance, California, United States

Newark, Delaware, United States

Bay Pines, Florida, United States

DeLand, Florida, United States

Doral, Florida, United States

Kissimmee, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

West Palm Beach, Florida, United States

Augusta, Georgia, United States

Blue Ridge, Georgia, United States

Decatur, Georgia, United States

Chicago, Illinois, United States

Springfield, Illinois, United States

Council Bluffs, Iowa, United States

Hazard, Kentucky, United States

Louisville, Kentucky, United States

Louisville, Kentucky, United States

Owensboro, Kentucky, United States

Lafayette, Louisiana, United States

Shreveport, Louisiana, United States

Detroit, Michigan, United States

Farmington Hills, Michigan, United States

Royal Oak, Michigan, United States

Duluth, Minnesota, United States

St Louis, Missouri, United States

Butte, Montana, United States

Newark, New Jersey, United States

Somers Point, New Jersey, United States

Buffalo, New York, United States

Jamaica, New York, United States

Johnson City, New York, United States

New York, New York, United States

Winston-Salem, North Carolina, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Lima, Ohio, United States

Bethleham, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Rapid City, South Dakota, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

Splendora, Texas, United States

Charlottesville, Virginia, United States

Spokane, Washington, United States

Caba, Buenos Aires, Argentina

Florencia Varela, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Loma Hermosa, Buenos Aires, Argentina

Mar del Plata, Buenos Aires, Argentina

San Juan Bautista, Buenos Aires, Argentina

Vicente López, Buenos Aires, Argentina

Córdoba, Córdoba Province, Argentina

Salta, Salta Province, Argentina

Rosario, Santa Fe Province, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Kozloduy, , Bulgaria

Montana, , Bulgaria

Pernik, , Bulgaria

Rousse, , Bulgaria

Samokov, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Vidin, , Bulgaria

Vratsa, , Bulgaria

Edmonton, Alberta, Canada

Surrey, British Columbia, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Chicoutimi, Quebec, Canada

Greenfield Park, Quebec, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

Talca, Maule Region, Chile

Viña del Mar, Región de Valparaíso, Chile

Providencia, RM, Chile

Temuco, , Chile

Medellín, Antioquia, Colombia

Cali, Valle del Cauca Department, Colombia

Batumi, , Georgia

Rustavi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Tbilisi, , Georgia

Bochum, , Germany

Bonn, , Germany

Dresden, , Germany

Greifswald, , Germany

Hanover, , Germany

Lübeck, , Germany

Rostock, , Germany

Guatemala City, Departamento de Guatemala, Guatemala

Guatemala City, Departamento de Guatemala, Guatemala

Guatemala City, , Guatemala

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Győr, , Hungary

Kaposvár, , Hungary

Nagykanizsa, , Hungary

Nyíregyháza, , Hungary

Pécs, , Hungary

Székesfehérvár, , Hungary

Törökbálint, , Hungary

Balvi, , Latvia

Daugavpils, , Latvia

Liepāja, , Latvia

Valmiera, , Latvia

Alor Star, Kedah, Malaysia

Kota Bharu, Kelantan, Malaysia

Cheras, Kuala Lumpur, Malaysia

Jalan Pahang, Kuala Lumpur, Malaysia

Malacca, Melaka, Malaysia

George Town, Pulau Pinang, Malaysia

George Town, Pulau Pinang, Malaysia

Miri, Sarawak, Malaysia

Ampang, Selangor, Malaysia

Batu Caves, Selangor, Malaysia

Sungai Buloh, Selangor, Malaysia

Maastricht, Limburg, Netherlands

Breda, North Brabant, Netherlands

Utrecht, Utrecht, Netherlands

Ica, Ica, Peru

Miraflores, Lima 18, Peru

Cercado, Lima 1, Peru

San Juán de Miraflores, Lima 29, Peru

San Martín de Porres, Lima 31, Peru

San Miguel, Lima 32, Peru

Santiago de Surco, Lima 33, Peru

San Borja, Lima 41, Peru

Jesus Maria, Lima11, Peru

Lima Cercado, Lima1, Peru

Cercado, Lima, Peru

Iquitos, Loreto, Peru

Bellavista, Provincia Constitucional del Callao, Peru

Lipa City, Batangas, Philippines

EDSA Caloocan City, National Capital Region, Philippines

Cebu City, , Philippines

Iloilo City, , Philippines

Quezon City, , Philippines

Quezon City, , Philippines

Chrzanów, , Poland

Krakow, , Poland

Krakow, , Poland

Lodz, , Poland

Poznan, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Marghita, Bihor County, Romania

Bucharest, București, Romania

Cluj-Napoca, Cluj, Romania

Constanța, Constanța County, Romania

Craiova, Dolj, Romania

Bragadiru, Judet Ilfov, Romania

Suceava, Judetual Suceava, Romania

Ploieşti, Prahova, Romania

Bucharest, Sector 1, Romania

Bucharest, Sector 2, Romania

Bucharest, Sector 2, Romania

Bucharest, Sector 3, Romania

Bucharest, Sector 5, Romania

Suceava, Suceava, Romania

Timișoara, Timiș County, Romania

Barnaul, , Russia

Chelyabinsk, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Novosibirsk, , Russia

Penza, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Smolensk, , Russia

Tomsk, , Russia

Belgrade, , Serbia

Belgrade, , Serbia

Kamenitz, , Serbia

Kragujevac, , Serbia

Niš, , Serbia

Kosice-Saca, Slovakia, Slovakia

Lučenec, Slovakia, Slovakia

Trebišov, , Slovakia

Golnik, , Slovenia

Ljubljana, , Slovenia

Topolšica, , Slovenia

Benoni, Gauteng, South Africa

Johannesburg, Gauteng, South Africa

Krugersdorp, Gauteng, South Africa

Newcastle, KwaZulu-Natal, South Africa

Thabazimbi, Limpopo, South Africa

Middleburg, Mpumalanga, South Africa

Observatory, Western Cape, South Africa

Anyang-si, Gyenggi-do, South Korea

Seoul, Gyenggi, South Korea

Seoul, Gyenggi, South Korea

Seoul, Gyenggi, South Korea

Seoul, Gyenggi, South Korea

Ansan-si, Gyeonggi-do, South Korea

Goyang-si, Gyeonggi-do, South Korea

Goyang-si, Gyeonggi-do, South Korea

Seoul, Gyeonggi-do, South Korea

Seoul, Gyeonggi-do, South Korea

Seoul, Gyeonggi-do, South Korea

Jeonju, Jeollabuk-do, South Korea

Badalona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Mataró, Barcelona, Spain

Granada, Granada, Spain

Madrid, Madrid, Spain

Torrejón de Ardoz, Madrid, Spain

Alicante, , Spain

Barcelona, , Spain

Madrid, , Spain

Taichung, R.o. C., Taiwan

Taichung, R.o. C., Taiwan

Taipei, R.o. C., Taiwan

Changhua Country, , Taiwan

Hualien City, , Taiwan

Kaohsiung City, , Taiwan

Kaohsiung City, , Taiwan

Kaohsiung City, , Taiwan

New Taipei City, , Taiwan

Taichung, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Chernivtsi, , Ukraine

Ivano Frakivsk, , Ukraine

Kharkiv, , Ukraine

Kharkiv, , Ukraine

Kharkiv, , Ukraine

Kherson, , Ukraine

Kiev, , Ukraine

Kremenchuk, , Ukraine

Sumy, , Ukraine

Vinnytsia, , Ukraine

Zaporizhzhia, , Ukraine

Zaporizhzhia, , Ukraine

Countries

United States; Argentina; Bulgaria; Canada; Chile; Colombia; Georgia; Germany; Guatemala; Hungary; Latvia; Malaysia; Netherlands; Peru; Philippines; Poland; Romania; Russia; Serbia; Slovakia; Slovenia; South Africa; South Korea; Spain; Taiwan; Ukraine

References

File TM Jr, Rewerska B, Vucinic-Mihailovic V, Gonong JRV, Das AF, Keedy K, Taylor D, Sheets A, Fernandes P, Oldach D, Jamieson BD. SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia. Clin Infect Dis. 2016 Oct 15;63(8):1007-1016. doi: 10.1093/cid/ciw490. Epub 2016 Jul 22.

Reference Type: DERIVED

PMID: 27448679 (View on PubMed)

Other Identifiers

CE01-301

Identifier Type: -

Identifier Source: org_study_id