Clinical trial NCT01968733: 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
Official title: 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
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: 2013-10-24
Enrollment: 863
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
* 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

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 Clinically Evaluable (CE) populations
timeFrame: 5 to 10 days after the last dose of study drug
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Chino
country: United States
state: California
city: Glendale
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Torrance
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Bay Pines
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Doral
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Blue Ridge
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Council Bluffs
country: United States
state: Iowa
city: Hazard
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Lafayette
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Farmington Hills
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Newark
country: United States
state: New Jersey
city: Somers Point
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Bethleham
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Rapid City
country: United States
state: South Dakota
city: Nashville
country: United States
state: Tennessee
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: Charlottesville
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Caba
country: Argentina
state: Buenos Aires
city: Florencia Varela
country: Argentina
state: Buenos Aires
city: Florencio Varela
country: Argentina
state: Buenos Aires
city: La Plata
country: Argentina
state: Buenos Aires
city: La Plata
country: Argentina
state: Buenos Aires
city: Loma Hermosa
country: Argentina
state: Buenos Aires
city: Mar del Plata
country: Argentina
state: Buenos Aires
city: Vicente Lopez
country: Argentina
state: Buenos Aires
city: Rosario
country: Argentina
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
state: Tucuman
city: Cordoba
country: Argentina
city: Salta
country: Argentina
city: Kozloduy
country: Bulgaria
city: Montana
country: Bulgaria
city: Pernik
country: Bulgaria
city: Russe
country: Bulgaria
city: Samokov
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Vidin
country: Bulgaria
city: Vratsa
country: Bulgaria
city: Edmonton
country: Canada
state: Alberta
city: Surrey
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Chicoutimi
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Providencia
country: Chile
state: RM
city: Vina del Mar
country: Chile
state: V Region
city: Talca
country: Chile
state: VII Region
city: Temuco
country: Chile
city: Medellin
country: Colombia
state: Antioquia
city: Cali
country: Colombia
state: Valle del Cauca
city: Batumi
country: Georgia
city: Rustavi
country: Georgia
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Tbilisi
country: Georgia
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Greifswald
country: Germany
city: Hannover
country: Germany
city: Lubeck
country: Germany
city: Rostock
country: Germany
city: Guatemala
country: Guatemala
city: Guatemala
country: Guatemala
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Kaposvar
country: Hungary
city: Nagykanizsa
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Szekesfehervar
country: Hungary
city: Torokbalint
country: Hungary
city: Anyang-si
country: Korea, Republic of
state: Gyenggi-do
city: Seoul
country: Korea, Republic of
state: Gyenggi
city: Seoul
country: Korea, Republic of
state: Gyenggi
city: Seoul
country: Korea, Republic of
state: Gyenggi
city: Seoul
country: Korea, Republic of
state: Gyenggi
city: Ansan-si
country: Korea, Republic of
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
state: Gyeonggi
city: Seoul
country: Korea, Republic of
state: Gyeonggi
city: Seoul
country: Korea, Republic of
state: Gyeonggi
city: Jeonju-si
country: Korea, Republic of
state: Jeollabuk-do
city: Balvi
country: Latvia
city: Daugavpils
country: Latvia
city: Liepaja
country: Latvia
city: Valmiera
country: Latvia
city: Alor Setar
country: Malaysia
state: Kedah
city: Kota Bharu
country: Malaysia
state: Kelantan
city: Cheras
country: Malaysia
state: Kuala Lumpur
city: Jalan Pahang
country: Malaysia
state: Kuala Lumpur
city: Georgetown
country: Malaysia
state: Penang
city: George Town
country: Malaysia
state: Pulau Pinang
city: Miri
country: Malaysia
state: Sarawak
city: Ampang
country: Malaysia
state: Selangor
city: Batu Caves
country: Malaysia
state: Selangor
city: Sungai Buloh
country: Malaysia
state: Selangor
city: Melaka
country: Malaysia
city: Maastricht
country: Netherlands
state: Limburg
city: Breda
country: Netherlands
state: Noord-Brabant
city: Utrecht
country: Netherlands
city: Bellavista
country: Peru
state: Callao
city: Miraflores
country: Peru
state: Lima 18
city: Cercado
country: Peru
state: Lima 1
city: San Juan de Miraflores
country: Peru
state: Lima 29
city: San Martin de Porres
country: Peru
state: Lima 31
city: San Miguel
country: Peru
state: Lima 32
city: Santiago de Surco
country: Peru
state: Lima 33
city: San Borja
country: Peru
state: Lima 41
city: Jesus Maria
country: Peru
state: Lima11
city: Cercado de Lima
country: Peru
state: Lima1
city: Cercado
country: Peru
state: Lima
city: Iquitos
country: Peru
state: Loreto
city: Ica
country: Peru
city: Lipa City
country: Philippines
state: Batangas
city: EDSA Caloocan City
country: Philippines
state: Metro Manila
city: Cebu City
country: Philippines
city: Iloilo City
country: Philippines
city: Quezon City
country: Philippines
city: Quezon City
country: Philippines
city: Chrzanow
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Marghita
country: Romania
state: Bihor
city: Cluj-Napoca
country: Romania
state: Cluj
city: Craiova
country: Romania
state: Dolj
city: Bragadiru
country: Romania
state: judet Ilfov
city: Suceava
country: Romania
state: Judetual Suceava
city: Suceava
country: Romania
state: Judetul Suceava
city: Ploiesti
country: Romania
state: Prahova
city: Bucuresti
country: Romania
state: Sector 1
city: Bucuresti
country: Romania
state: Sector 2
city: Bucuresti
country: Romania
state: Sector 2
city: Bucuresti
country: Romania
state: Sector 3
city: Bucuresti
country: Romania
state: Sector 5
city: Timisoara
country: Romania
state: Timis
city: Bucuresti
country: Romania
city: Constanta
country: Romania
city: Barnaul
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Penza
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Kosice-Saca
country: Slovakia
city: Lucenec
country: Slovakia
city: Trebisov
country: Slovakia
city: Golnik
country: Slovenia
city: Ljubljana
country: Slovenia
city: Topolsica
country: Slovenia
city: Benoni
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Krugersdorp
country: South Africa
state: Gauteng
city: Newcastle
country: South Africa
state: Kwazulu, Natal
city: Thabazimbi
country: South Africa
state: Limpopo
city: Middleburg
country: South Africa
state: Mpumalanga
city: Observatory
country: South Africa
state: Western Cape
city: Badalona
country: Spain
state: Barcelona
city: Mataro
country: Spain
state: Barcelona
city: Torrejon de Ardoz
country: Spain
state: Madrid
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Taichung
country: Taiwan
state: R.o. C.
city: Taichung
country: Taiwan
state: R.o. C.
city: Taipei City
country: Taiwan
state: R.o. C.
city: Changhua Country
country: Taiwan
city: Hualien
country: Taiwan
city: Kaohsiung City
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: New Taipei City
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan City
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei City
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Chernivtsi
country: Ukraine
city: Ivano Frakivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kiev
country: Ukraine
city: Kremenchuk
country: Ukraine
city: Sumy
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Brian D Jamieson, MD
role: STUDY_DIRECTOR
References:
citation: 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.