Clinical trial NCT01756339: Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community-acquired Bacterial Pneumonia
Keywords: Pneumonia
CABP
CAP
Macrolide
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-25
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Early clinical response rate in the Intent to Treat (ITT) population
timeFrame: 72 [±12] hours after the first dose of study drug
Secondary outcomes:
measure: Early clinical response rate in the microITT population
timeFrame: 72 [±12] hours after the first dose of study drug
measure: Clinical success rates in the ITT and Clincally Evaluable (CE) populations
timeFrame: 5 to 10 days after the last dose of study drug
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Torrance
country: United States
state: California
city: Debary
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: St Cloud
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Duluth
country: United States
state: Georgia
city: New Bedford
country: United States
state: Massachusetts
city: Butte
country: United States
state: Montana
city: Columbus
country: United States
state: Ohio
city: Downingtown
country: United States
state: Pennsylvania
city: Summerville
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Splendora
country: United States
state: Texas
city: La Plata
country: Argentina
state: Buenos Aires
city: Tandil
country: Argentina
state: Buenos Aires
city: Loma Hermosa
country: Argentina
state: Provincia de Buenos Aires
city: Rosario
country: Argentina
state: Santa Fe
city: San Miguel De Tucuman
country: Argentina
state: Tucuman
city: Caba
country: Argentina
city: Ciudad Autonoma de Buenos Aires
country: Argentina
city: Ciudad Autonoma de Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Santa Fe
country: Argentina
city: Pernik
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Cornwall
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Beroun
country: Czech Republic
city: Santo Domingo
country: Dominican Republic
city: Santo Domingo
country: Dominican Republic
city: Guayaquil
country: Ecuador
state: Guayas
city: Guayaquil
country: Ecuador
city: Quito
country: Ecuador
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Hofheim
country: Germany
state: De-he
city: Rotenburg (Wuemme)
country: Germany
state: De-ni
city: Hannover
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Kecskemet
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Daugavpils
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Zgierz
country: Poland
city: San Juan
country: Puerto Rico
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: St Petersburg
country: Russian Federation
state: Leningrad Region
city: St Petersburg
country: Russian Federation
state: Leningrad Region
city: St Petersburg
country: Russian Federation
state: Leningrad Region
city: Smolensk
country: Russian Federation
state: Smolensk Region
city: Chelyabinsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Thabazimbi
country: South Africa
state: Limpopo
city: Halfway House
country: South Africa
state: Midrand
city: Middelburg
country: South Africa
state: Mpumalanga
city: Witbank
country: South Africa
state: Mpumalanga
city: Korsten
country: South Africa
state: Port Elizabeth
city: Hillcrest
country: South Africa
state: Pretoria
city: Benoni
country: South Africa
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Krugersdorp
country: South Africa
city: Pretoria
country: South Africa
city: Worcester
country: South Africa
city: Badalona
country: Spain
state: Barcelona
city: Majadahonda
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Mataro
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: David Oldach, MD
role: STUDY_DIRECTOR
References:
citation: 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.