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
SOLITAIRE-IV
A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
1 other identifier
interventional
863
25 countries
267
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2013
267 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 24, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 3, 2017
March 1, 2017
1.7 years
October 21, 2013
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Early clinical response rate in the microITT population
72 [±12] hours after the first dose of study drug
Clinical success rates in the ITT and Clinically Evaluable (CE) populations
5 to 10 days after the last dose of study drug
Study Arms (2)
Moxifloxacin
ACTIVE COMPARATORIntravenous with the potential step-down to oral moxifloxacin
Solithromycin
EXPERIMENTALIntravenous with potential step-down to oral solithromycin
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients ≥ 18 years of age
- An acute onset of at least 3 of the following signs and symptoms (new or worsening):
- Cough
- Production of purulent sputum
- Shortness of breath (dyspnea)
- Chest pain due to pneumonia
- At least 1 of the following:
- Fever
- Hypothermia
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (270)
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Mobile, Alabama, 36607, United States
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Mobile, Alabama, 36609, United States
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Little Rock, Arkansas, 72205, United States
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Chino, California, 91710, United States
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Glendale, California, 91206, United States
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Laguna Hills, California, 92653, United States
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Los Angeles, California, 90015, United States
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Pasadena, California, 91105, United States
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Sacramento, California, 95817, United States
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Sylmar, California, 91342, United States
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Torrance, California, 90502, United States
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Newark, Delaware, 19713, United States
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Bay Pines, Florida, 33744, United States
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DeLand, Florida, 32720, United States
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Doral, Florida, 33166, United States
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Kissimmee, Florida, 34741, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33156, United States
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West Palm Beach, Florida, 33401, United States
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Augusta, Georgia, 30912, United States
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Blue Ridge, Georgia, 30513, United States
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Decatur, Georgia, 30033, United States
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Chicago, Illinois, 60611, United States
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Springfield, Illinois, 62702, United States
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Council Bluffs, Iowa, 51503, United States
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Hazard, Kentucky, 41701, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40206, United States
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Owensboro, Kentucky, 42303, United States
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Lafayette, Louisiana, 70503, United States
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Shreveport, Louisiana, 71103, United States
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Detroit, Michigan, 48202, United States
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Farmington Hills, Michigan, 48334, United States
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Royal Oak, Michigan, 48073, United States
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Duluth, Minnesota, 55805, United States
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St Louis, Missouri, 63110, United States
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Butte, Montana, 59701, United States
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Newark, New Jersey, 07102, United States
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Somers Point, New Jersey, 08244, United States
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Buffalo, New York, 14215, United States
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Jamaica, New York, 11418, United States
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Johnson City, New York, 13790, United States
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New York, New York, 10003, United States
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Winston-Salem, North Carolina, 27103, United States
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Akron, Ohio, 44304, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44106, United States
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Columbus, Ohio, 43210, United States
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Dayton, Ohio, 45402, United States
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Lima, Ohio, 45801, United States
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Bethleham, Pennsylvania, 18015, United States
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Philadelphia, Pennsylvania, 19141, United States
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Wyomissing, Pennsylvania, 19610, United States
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Rapid City, South Dakota, 57702, United States
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Nashville, Tennessee, 37232, United States
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Houston, Texas, 77011, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77093, United States
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Splendora, Texas, 77372, United States
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Charlottesville, Virginia, 22905-2877, United States
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Spokane, Washington, 99202, United States
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Caba, Buenos Aires, C1093AAS, Argentina
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Florencia Varela, Buenos Aires, B1887FWB, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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La Plata, Buenos Aires, B1900AVG, Argentina
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Loma Hermosa, Buenos Aires, B1657BHD, Argentina
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Mar del Plata, Buenos Aires, B7600GNY, Argentina
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San Juan Bautista, Buenos Aires, 1888, Argentina
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Vicente López, Buenos Aires, B1602DOH, Argentina
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Córdoba, Córdoba Province, X5000JRD, Argentina
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Salta, Salta Province, 4400, Argentina
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Rosario, Santa Fe Province, S2000CVB, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina
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Kozloduy, 3320, Bulgaria
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Montana, 3400, Bulgaria
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Pernik, 2300, Bulgaria
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Rousse, 7002, Bulgaria
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Samokov, 2000, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Vidin, 3700, Bulgaria
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Vratsa, 3000, Bulgaria
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Edmonton, Alberta, T6G2B7, Canada
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Surrey, British Columbia, V3V 1Z2, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Winnipeg, Manitoba, R3E0J9, Canada
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Chicoutimi, Quebec, G7H5H6, Canada
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Greenfield Park, Quebec, J4V2H1, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Sherbrooke, Quebec, JIH-5N4, Canada
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Talca, Maule Region, 3465584, Chile
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Viña del Mar, Región de Valparaíso, 2540364, Chile
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Providencia, RM, 7500710, Chile
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Temuco, 4800997, Chile
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Medellín, Antioquia, Colombia
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Cali, Valle del Cauca Department, Colombia
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Batumi, 6004, Georgia
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Rustavi, 3700, Georgia
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Tbilisi, 0101, Georgia
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Tbilisi, 0112, Georgia
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Tbilisi, 0144, Georgia
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Tbilisi, 0159, Georgia
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Tbilisi, 0160, Georgia
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Tbilisi, 0186, Georgia
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Bochum, 44789, Germany
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Bonn, 53105, Germany
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Dresden, 01307, Germany
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Greifswald, 17475, Germany
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Hanover, 30625, Germany
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Lübeck, 23538, Germany
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Rostock, 18055, Germany
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Guatemala City, Departamento de Guatemala, 01010, Guatemala
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Guatemala City, Departamento de Guatemala, 01016, Guatemala
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Guatemala City, 01010, Guatemala
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Budapest, H-1097, Hungary
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Budapest, H-1121, Hungary
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Budapest, H-1125, Hungary
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Budapest, H-1145, Hungary
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Budapest, H-115, Hungary
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Debrecen, H-1051, Hungary
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Győr, H-9024, Hungary
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Kaposvár, H-7400, Hungary
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Nagykanizsa, H-8800, Hungary
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Nyíregyháza, H-4412, Hungary
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Pécs, H-7623, Hungary
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Székesfehérvár, H-8000, Hungary
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Törökbálint, H-2045, Hungary
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Balvi, LV-4501, Latvia
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Daugavpils, LV-5417, Latvia
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Liepāja, LV-3414, Latvia
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Valmiera, LV-4201, Latvia
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Alor Star, Kedah, 05460, Malaysia
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Kota Bharu, Kelantan, 15586, Malaysia
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Cheras, Kuala Lumpur, 56000, Malaysia
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Jalan Pahang, Kuala Lumpur, 50586, Malaysia
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Malacca, Melaka, 75400, Malaysia
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George Town, Pulau Pinang, 10400, Malaysia
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George Town, Pulau Pinang, 10990, Malaysia
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Miri, Sarawak, 98000, Malaysia
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Ampang, Selangor, 68000, Malaysia
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Batu Caves, Selangor, 68100, Malaysia
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Sungai Buloh, Selangor, 47000, Malaysia
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Maastricht, Limburg, 6229 HX, Netherlands
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Breda, North Brabant, 4818 CK, Netherlands
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Utrecht, Utrecht, 3584 CX, Netherlands
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Ica, Ica, Peru
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Miraflores, Lima 18, Lima 18, Peru
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Cercado, Lima 1, Lima 1, Peru
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San Juán de Miraflores, Lima 29, Lima 29, Peru
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San Martín de Porres, Lima 31, Lima 31, Peru
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San Miguel, Lima 32, Lima 32, Peru
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Santiago de Surco, Lima 33, Lima 33, Peru
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San Borja, Lima 41, Lima 41, Peru
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Jesus Maria, Lima11, Lima11, Peru
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Lima Cercado, Lima1, Lima1, Peru
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Cercado, Lima, Lima01, Peru
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Iquitos, Loreto, Peru
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Bellavista, Provincia Constitucional del Callao, Callao, Peru
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Lipa City, Batangas, 4217, Philippines
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EDSA Caloocan City, National Capital Region, 1400, Philippines
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Cebu City, 6000, Philippines
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Iloilo City, 5000, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1109, Philippines
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Chrzanów, 32-500, Poland
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Krakow, 31-011, Poland
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Krakow, 31-209, Poland
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Lodz, 90-153, Poland
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Poznan, 60-569, Poland
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Warsaw, 01-138, Poland
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Warsaw, 02-507, Poland
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Wroclaw, 21-162, Poland
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Marghita, Bihor County, 415300, Romania
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Bucharest, București, 011461, Romania
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Cluj-Napoca, Cluj, 400371, Romania
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Constanța, Constanța County, 900002, Romania
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Craiova, Dolj, 200515, Romania
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Bragadiru, Judet Ilfov, 769764, Romania
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Suceava, Judetual Suceava, 720284, Romania
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Ploieşti, Prahova, 10097, Romania
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Bucharest, Sector 1, 010824, Romania
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Bucharest, Sector 2, 021105, Romania
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Bucharest, Sector 2, 021661, Romania
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Bucharest, Sector 3, 030303, Romania
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Bucharest, Sector 5, 050159, Romania
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Suceava, Suceava, 720284, Romania
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Timișoara, Timiș County, 300310, Romania
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Barnaul, 656045, Russia
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Chelyabinsk, 454021, Russia
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Moscow, 119991, Russia
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Moscow, 123182, Russia
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Moscow, 127206, Russia
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Novosibirsk, 195271, Russia
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Penza, 440067, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 195030, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 198205, Russia
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Smolensk, 214019, Russia
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Tomsk, 634063, Russia
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Belgrade, 11000, Serbia
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Belgrade, 11080, Serbia
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Kamenitz, 21204, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Kosice-Saca, Slovakia, 04015, Slovakia
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Lučenec, Slovakia, 98401, Slovakia
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Trebišov, 07501, Slovakia
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Golnik, 4204, Slovenia
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Ljubljana, 1000, Slovenia
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Topolšica, 3326, Slovenia
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Benoni, Gauteng, 1501, South Africa
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Johannesburg, Gauteng, 2113, South Africa
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Krugersdorp, Gauteng, 1739, South Africa
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Newcastle, KwaZulu-Natal, 2940, South Africa
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Thabazimbi, Limpopo, 0380, South Africa
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Middleburg, Mpumalanga, 1055, South Africa
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Observatory, Western Cape, 7925, South Africa
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Anyang-si, Gyenggi-do, 431-796, South Korea
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Seoul, Gyenggi, 135-710, South Korea
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Seoul, Gyenggi, 138-736, South Korea
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Seoul, Gyenggi, 156-707, South Korea
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Seoul, Gyenggi, 158-710, South Korea
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Ansan-si, Gyeonggi-do, 425-707, South Korea
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Goyang-si, Gyeonggi-do, 410-719, South Korea
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Goyang-si, Gyeonggi-do, 411-706, South Korea
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Seoul, Gyeonggi-do, 136-705, South Korea
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Seoul, Gyeonggi-do, 143-729, South Korea
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Seoul, Gyeonggi-do, 150-950, South Korea
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Jeonju, Jeollabuk-do, 561-712, South Korea
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Badalona, Barcelona, 08916, Spain
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Barcelona, Barcelona, 08003, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Mataró, Barcelona, 08304, Spain
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Granada, Granada, 18014, Spain
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Madrid, Madrid, 28040, Spain
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Torrejón de Ardoz, Madrid, 28850, Spain
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Alicante, 03010, Spain
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Barcelona, 08221, Spain
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Madrid, 28046, Spain
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Taichung, R.o. C., 40447, Taiwan
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Taichung, R.o. C., 407, Taiwan
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Taipei, R.o. C., 116, Taiwan
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Changhua Country, 500, Taiwan
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Hualien City, 970, Taiwan
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Kaohsiung City, 807, Taiwan
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, 83301, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 402, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Tainan, 710, Taiwan
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Taipei, 100, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Chernivtsi, 58000, Ukraine
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Ivano Frakivsk, 76018, Ukraine
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Kharkiv, 61103, Ukraine
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Kharkiv, 61106, Ukraine
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Kharkiv, 61124, Ukraine
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Kherson, 73000, Ukraine
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Kiev, 01133, Ukraine
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Kremenchuk, 39617, Ukraine
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Sumy, 40022, Ukraine
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Vinnytsia, 21029, Ukraine
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Zaporizhzhia, 69035, Ukraine
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Zaporizhzhia, 69065, Ukraine
Related Publications (1)
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.
PMID: 27448679DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian D Jamieson, MD
Melinta Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2013
First Posted
October 24, 2013
Study Start
November 1, 2013
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
March 3, 2017
Record last verified: 2017-03