Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
NCT ID: NCT01756339
Last Updated: 2017-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
860 participants
INTERVENTIONAL
2012-12-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Solithromycin
Placebo to match solithromycin
Moxifloxacin
Moxifloxacin 400 mg PO daily on Day 1 through Day 7
Moxifloxacin
Interventions
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Solithromycin
Moxifloxacin
Placebo to match solithromycin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Melinta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Oldach, MD
Role: STUDY_DIRECTOR
Melinta Therapeutics, Inc.
Locations
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Glendale, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
Oxnard, California, United States
Pasadena, California, United States
Sylmar, California, United States
Torrance, California, United States
DeBary, Florida, United States
DeLand, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Saint Cloud, Florida, United States
Tampa, Florida, United States
Duluth, Georgia, United States
New Bedford, Massachusetts, United States
Butte, Montana, United States
Columbus, Ohio, United States
Downingtown, Pennsylvania, United States
Summerville, South Carolina, United States
Rapid City, South Dakota, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Splendora, Texas, United States
La Plata, Buenos Aires, Argentina
Loma Hermosa, Buenos Aires, Argentina
Tandil, Buenos Aires, Argentina
Córdoba, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Santa Fe, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Caba, , Argentina
Pernik, Bulgaria, Bulgaria
Rousse, Bulgaria, Bulgaria
Sofia, Bulgaria, Bulgaria
Sofia, Bulgaria, Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Cornwall, Ontario, Canada
Montreal, Quebec, Canada
Beroun, , Czechia
Santo Domingo, , Dominican Republic
Santo Domingo, , Dominican Republic
Guayaquil, Guayas, Ecuador
Guayaquil, , Ecuador
Quito, , Ecuador
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Hofheim, De-he, Germany
Rotenburg (Wümme), De-ni, Germany
Hanover, , Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Kecskemét, , Hungary
Nyíregyháza, , Hungary
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Riga, , Latvia
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Zgierz, , Poland
San Juan, , Puerto Rico
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Craiova, , Romania
Iași, , Romania
Timișoara, , Romania
Saint Petersburg, Leningradskaya Oblast', Russia
Saint Petersburg, Leningradskaya Oblast', Russia
Saint Petersburg, Leningradskaya Oblast', Russia
Smolensk, Smolensk Oblast, Russia
Chelyabinsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Thabazimbi, Limpopo, South Africa
Halfway House, Midrand, South Africa
Middelburg, Mpumalanga, South Africa
Witbank, Mpumalanga, South Africa
Korsten, Port Elizabeth, South Africa
Hillcrest, Pretoria, South Africa
Benoni, , South Africa
Bloemfontein, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Krugersdorp, , South Africa
Pretoria, , South Africa
Worcester, , South Africa
Badalona, Barcelona, Spain
Majadahonda, Madrid, Spain
Valencia, Valencia, Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Mataró, , Spain
Countries
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References
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Barrera CM, Mykietiuk A, Metev H, Nitu MF, Karimjee N, Doreski PA, Mitha I, Tanaseanu CM, Molina JM, Antonovsky Y, Van Rensburg DJ, Rowe BH, Flores-Figueroa J, Rewerska B, Clark K, Keedy K, Sheets A, Scott D, Horwith G, Das AF, Jamieson B, Fernandes P, Oldach D; SOLITAIRE-ORAL Pneumonia Team. Efficacy and safety of oral solithromycin versus oral moxifloxacin for treatment of community-acquired bacterial pneumonia: a global, double-blind, multicentre, randomised, active-controlled, non-inferiority trial (SOLITAIRE-ORAL). Lancet Infect Dis. 2016 Apr;16(4):421-30. doi: 10.1016/S1473-3099(16)00017-7. Epub 2016 Feb 5.
Other Identifiers
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CE01-300
Identifier Type: -
Identifier Source: org_study_id
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