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

NCT01756339 | Completed Phase 3 DMC

• 1 other identifier: CE01-300
• Study Type: interventional
• Target: 860
• Locations: 16 countries
• Sites: 112

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.

Conditions

Community-acquired Bacterial Pneumonia

Keywords

Pneumonia; CABP; CAP; Macrolide

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 Clincally Evaluable (CE) populations

  5 to 10 days after the last dose of study drug

Study Arms (2)

Solithromycin

EXPERIMENTAL

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: Placebo to match solithromycin

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin 400 mg PO daily on Day 1 through Day 7

Drug: Moxifloxacin

Interventions

Solithromycin DRUG

Also known as: CEM-101

Solithromycin

Moxifloxacin DRUG

Also known as: Avelox

Moxifloxacin

Placebo to match solithromycin OTHER

Solithromycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Presence of known:
• Viral or fungal pneumonia
• Pneumocystis jiroveci pneumonia
• Aspiration pneumonia
• Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)
• Primary or metastatic lung cancer
• Cystic fibrosis
• Active or suspected tuberculosis
• Known HIV or myasthesia gravis

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (119)

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Glendale, California, 91206, United States

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Los Angeles, California, 90015, United States

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Mission Hills, California, 91345, United States

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Oxnard, California, 93030, United States

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Pasadena, California, 91105, United States

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Sylmar, California, 91342, United States

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Torrance, California, 90502, United States

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DeBary, Florida, 32713, United States

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DeLand, Florida, 32720, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33144, United States

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Saint Cloud, Florida, 34769, United States

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Tampa, Florida, 33606, United States

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Duluth, Georgia, 30096, United States

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New Bedford, Massachusetts, 02740, United States

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Butte, Montana, 59701, United States

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Columbus, Ohio, 43035, United States

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Downingtown, Pennsylvania, 19335, United States

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Summerville, South Carolina, 29485, United States

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Rapid City, South Dakota, 57702, United States

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Houston, Texas, 77011, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77070, United States

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Houston, Texas, 77093, United States

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Splendora, Texas, 77372, United States

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La Plata, Buenos Aires, B1900AVG, Argentina

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Loma Hermosa, Buenos Aires, B1657BHD, Argentina

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Tandil, Buenos Aires, B7000AXD, Argentina

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Córdoba, Córdoba Province, X5000JRD, Argentina

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Rosario, Santa Fe Province, S2000CVB, Argentina

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Santa Fe, Santa Fe Province, S3000EOZ, Argentina

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San Miguel de Tucumán, Tucumán Province, T4000IAR, Argentina

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Buenos Aires, 1426, Argentina

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Buenos Aires, C1425BEA, Argentina

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Caba, C1120AAF, Argentina

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Pernik, Bulgaria, 2300, Bulgaria

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Rousse, Bulgaria, 7002, Bulgaria

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Sofia, Bulgaria, 1431, Bulgaria

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Sofia, Bulgaria, 1709, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1336, Bulgaria

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Sofia, 1431, Bulgaria

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Edmonton, Alberta, T6G 2B7, Canada

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Vancouver, British Columbia, V1Y 1S1, Canada

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Cornwall, Ontario, K6H 4M4, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Beroun, 266 01, Czechia

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Santo Domingo, 10205, Dominican Republic

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Santo Domingo, 10511, Dominican Republic

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Guayaquil, Guayas, EC090103, Ecuador

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Guayaquil, Ecuador

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Quito, Ecuador

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Tallinn, 10617, Estonia

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Tallinn, 13619, Estonia

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Tartu, 51014, Estonia

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Hofheim, De-he, 65719, Germany

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Rotenburg (Wümme), De-ni, 27356, Germany

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Hanover, 30173, Germany

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Budapest, 1121, Hungary

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Budapest, 1122, Hungary

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Budapest, 1125, Hungary

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Kecskemét, 6000, Hungary

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Nyíregyháza, 4400, Hungary

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Daugavpils, LV5417, Latvia

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Liepāja, LV 3414, Latvia

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Riga, LV-1002, Latvia

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Riga, LV-1057, Latvia

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Krakow, 31011, Poland

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Lodz, 90153, Poland

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Lublin, 20090, Poland

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Zgierz, 95100, Poland

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San Juan, 00921, Puerto Rico

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Bucharest, 010825, Romania

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Bucharest, 021659, Romania

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Bucharest, 030303, Romania

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Craiova, 200515, Romania

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Iași, 700115, Romania

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Timișoara, 300310, Romania

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Saint Petersburg, Leningradskaya Oblast', 194354, Russia

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Saint Petersburg, Leningradskaya Oblast', 196211, Russia

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Saint Petersburg, Leningradskaya Oblast', 198205, Russia

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Smolensk, Smolensk Oblast, 214019, Russia

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Chelyabinsk, 454008, Russia

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Moscow, 109240, Russia

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Moscow, 111539, Russia

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Moscow, 115446, Russia

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Moscow, 119991, Russia

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Moscow, 123182, Russia

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Moscow, 125206, Russia

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Moscow, 125284, Russia

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Saint Petersburg, 192242, Russia

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Saint Petersburg, 193312, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 195271, Russia

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Saint Petersburg, 196247, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 199106, Russia

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Smolensk, 214019, Russia

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Thabazimbi, Limpopo, 0380, South Africa

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Halfway House, Midrand, 1685, South Africa

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Middelburg, Mpumalanga, 1055, South Africa

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Witbank, Mpumalanga, 1035, South Africa

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Korsten, Port Elizabeth, 6014, South Africa

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Hillcrest, Pretoria, 0083, South Africa

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Benoni, 1500, South Africa

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Bloemfontein, 9300, South Africa

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Cape Town, 7530, South Africa

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Cape Town, 7570, South Africa

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Cape Town, 7764, South Africa

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Krugersdorp, 1739, South Africa

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Pretoria, 0001, South Africa

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Worcester, 6850, South Africa

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Badalona, Barcelona, 08916, Spain

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Majadahonda, Madrid, 28222, Spain

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Valencia, Valencia, 46026, Spain

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Barcelona, 08036, Spain

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Madrid, 28046, Spain

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Madrid, 28850, Spain

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Mataró, 08304, Spain

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Related Publications (1)

• 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.

  PMID: 26852726 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

solithromycin; Moxifloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Oldach, MD

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

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: December 20, 2012
• First Posted: December 25, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

RU (20); ZA (14); BU (7); AR (10); CZ (1); CA (4); PR (1); LA (4); DO (2); ES (3); HU (5); PL (4); RO (6); US (25); DE (3); EC (3)