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)

March 1, 2017 updated by: Melinta Therapeutics, Inc.

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

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

863

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5000JRD
      • Salta, Argentina, 4400
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1093AAS
      • Florencia Varela, Buenos Aires, Argentina, B1887FWB
      • Florencio Varela, Buenos Aires, Argentina, 1888
      • La Plata, Buenos Aires, Argentina, B1900AVG
      • La Plata, Buenos Aires, Argentina, 1900
      • Loma Hermosa, Buenos Aires, Argentina, B1657BHD
      • Mar del Plata, Buenos Aires, Argentina, B7600GNY
      • Vicente Lopez, Buenos Aires, Argentina, B1602DOH
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CVB
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
  • Bulgaria
      • Kozloduy, Bulgaria, 3320
      • Montana, Bulgaria, 3400
      • Pernik, Bulgaria, 2300
      • Russe, Bulgaria, 7002
      • Samokov, Bulgaria, 2000
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1606
      • Vidin, Bulgaria, 3700
      • Vratsa, Bulgaria, 3000
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E0J9
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H5H6
      • Greenfield Park, Quebec, Canada, J4V2H1
      • Montreal, Quebec, Canada, H2W 1T8
      • Sherbrooke, Quebec, Canada, JIH-5N4
  • Chile
      • Temuco, Chile, 4800997
    • RM
      • Providencia, RM, Chile, 7500710
    • V Region
      • Vina del Mar, V Region, Chile, 2540364
    • VII Region
      • Talca, VII Region, Chile, 3465584
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
    • Valle del Cauca
      • Cali, Valle del Cauca, Colombia
  • Georgia
      • Batumi, Georgia, 6004
      • Rustavi, Georgia, 3700
      • Tbilisi, Georgia, 0101
      • Tbilisi, Georgia, 0112
      • Tbilisi, Georgia, 0144
      • Tbilisi, Georgia, 0159
      • Tbilisi, Georgia, 0160
      • Tbilisi, Georgia, 0186
  • Germany
      • Bochum, Germany, 44789
      • Bonn, Germany, 53105
      • Dresden, Germany, 01307
      • Greifswald, Germany, 17475
      • Hannover, Germany, 30625
      • Lubeck, Germany, 23538
      • Rostock, Germany, 18055
  • Guatemala
      • Guatemala, Guatemala, 01010
      • Guatemala, Guatemala, 01016
  • Hungary
      • Budapest, Hungary, H-1097
      • Budapest, Hungary, H-1121
      • Budapest, Hungary, H-1125
      • Budapest, Hungary, H-1145
      • Budapest, Hungary, H-115
      • Debrecen, Hungary, H-1051
      • Gyor, Hungary, H-9024
      • Kaposvar, Hungary, H-7400
      • Nagykanizsa, Hungary, H-8800
      • Nyiregyhaza, Hungary, H-4412
      • Pecs, Hungary, H-7623
      • Szekesfehervar, Hungary, H-8000
      • Torokbalint, Hungary, H-2045
  • Korea, Republic of
    • Gyenggi
      • Seoul, Gyenggi, Korea, Republic of, 135-710
      • Seoul, Gyenggi, Korea, Republic of, 138-736
      • Seoul, Gyenggi, Korea, Republic of, 156-707
      • Seoul, Gyenggi, Korea, Republic of, 158-710
    • Gyenggi-do
      • Anyang-si, Gyenggi-do, Korea, Republic of, 431-796
    • Gyeonggi
      • Seoul, Gyeonggi, Korea, Republic of, 136-705
      • Seoul, Gyeonggi, Korea, Republic of, 143-729
      • Seoul, Gyeonggi, Korea, Republic of, 150-950
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Korea, Republic of, 425-707
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-719
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
    • Jeollabuk-do
      • Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
  • Latvia
      • Balvi, Latvia, LV-4501
      • Daugavpils, Latvia, LV-5417
      • Liepaja, Latvia, LV-3414
      • Valmiera, Latvia, LV-4201
  • Malaysia
      • Melaka, Malaysia, 75400
    • Kedah
      • Alor Setar, Kedah, Malaysia, 05460
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
      • Jalan Pahang, Kuala Lumpur, Malaysia, 50586
    • Penang
      • Georgetown, Penang, Malaysia, 10400
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
    • Sarawak
      • Miri, Sarawak, Malaysia, 98000
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
      • Batu Caves, Selangor, Malaysia, 68100
      • Sungai Buloh, Selangor, Malaysia, 47000
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
    • Noord-Brabant
      • Breda, Noord-Brabant, Netherlands, 4818 CK
  • Peru
      • Ica, Peru
    • Callao
      • Bellavista, Callao, Peru, Callao
    • Lima
      • Cercado, Lima, Peru, Lima01
    • Lima 1
      • Cercado, Lima 1, Peru, Lima 1
    • Lima 18
      • Miraflores, Lima 18, Peru, Lima 18
    • Lima 29
      • San Juan de Miraflores, Lima 29, Peru, Lima 29
    • Lima 31
      • San Martin de Porres, Lima 31, Peru, Lima 31
    • Lima 32
      • San Miguel, Lima 32, Peru, Lima 32
    • Lima 33
      • Santiago de Surco, Lima 33, Peru, Lima 33
    • Lima 41
      • San Borja, Lima 41, Peru, Lima 41
    • Lima1
      • Cercado de Lima, Lima1, Peru, Lima1
    • Lima11
      • Jesus Maria, Lima11, Peru, Lima11
    • Loreto
      • Iquitos, Loreto, Peru
  • Philippines
      • Cebu City, Philippines, 6000
      • Iloilo City, Philippines, 5000
      • Quezon City, Philippines, 1100
      • Quezon City, Philippines, 1109
    • Batangas
      • Lipa City, Batangas, Philippines, 4217
    • Metro Manila
      • EDSA Caloocan City, Metro Manila, Philippines, 1400
  • Poland
      • Chrzanow, Poland, 32-500
      • Krakow, Poland, 31-011
      • Krakow, Poland, 31-209
      • Lodz, Poland, 90-153
      • Poznan, Poland, 60-569
      • Warszawa, Poland, 01-138
      • Warszawa, Poland, 02-507
      • Wroclaw, Poland, 21-162
  • Romania
      • Bucuresti, Romania, 011461
      • Constanta, Romania, 900002
    • Bihor
      • Marghita, Bihor, Romania, 415300
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400371
    • Dolj
      • Craiova, Dolj, Romania, 200515
    • Judetual Suceava
      • Suceava, Judetual Suceava, Romania, 720284
    • Judetul Suceava
      • Suceava, Judetul Suceava, Romania, 720284
    • Prahova
      • Ploiesti, Prahova, Romania, 10097
    • Sector 1
      • Bucuresti, Sector 1, Romania, 010824
    • Sector 2
      • Bucuresti, Sector 2, Romania, 021105
      • Bucuresti, Sector 2, Romania, 021661
    • Sector 3
      • Bucuresti, Sector 3, Romania, 030303
    • Sector 5
      • Bucuresti, Sector 5, Romania, 050159
    • Timis
      • Timisoara, Timis, Romania, 300310
    • judet Ilfov
      • Bragadiru, judet Ilfov, Romania, 769764
  • Russian Federation
      • Barnaul, Russian Federation, 656045
      • Chelyabinsk, Russian Federation, 454021
      • Moscow, Russian Federation, 119991
      • Moscow, Russian Federation, 123182
      • Moscow, Russian Federation, 127206
      • Novosibirsk, Russian Federation, 195271
      • Penza, Russian Federation, 440067
      • Saint-Petersburg, Russian Federation, 195030
      • Saint-Petersburg, Russian Federation, 198205
      • Smolensk, Russian Federation, 214019
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 195271
      • Tomsk, Russian Federation, 634063
  • Serbia
      • Belgrade, Serbia, 11000
      • Belgrade, Serbia, 11080
      • Kragujevac, Serbia, 34000
      • Nis, Serbia, 18000
      • Sremska Kamenica, Serbia, 21204
  • Slovakia
      • Kosice-Saca, Slovakia, 04015
      • Lucenec, Slovakia, 98401
      • Trebisov, Slovakia, 07501
  • Slovenia
      • Golnik, Slovenia, 4204
      • Ljubljana, Slovenia, 1000
      • Topolsica, Slovenia, 3326
  • South Africa
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
      • Johannesburg, Gauteng, South Africa, 2113
      • Krugersdorp, Gauteng, South Africa, 1739
    • Kwazulu, Natal
      • Newcastle, Kwazulu, Natal, South Africa, 2940
    • Limpopo
      • Thabazimbi, Limpopo, South Africa, 0380
    • Mpumalanga
      • Middleburg, Mpumalanga, South Africa, 1055
    • Western Cape
      • Observatory, Western Cape, South Africa, 7925
  • Spain
      • Alicante, Spain, 03010
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08221
      • Granada, Spain, 18014
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
      • Mataro, Barcelona, Spain, 08304
    • Madrid
      • Torrejon de Ardoz, Madrid, Spain, 28850
  • Taiwan
      • Changhua Country, Taiwan, 500
      • Hualien, Taiwan, 970
      • Kaohsiung, Taiwan, 83301
      • Kaohsiung, Taiwan, 807
      • Kaohsiung City, Taiwan, 82445
      • New Taipei City, Taiwan, 220
      • Taichung, Taiwan, 40705
      • Taichung, Taiwan, 402
      • Tainan, Taiwan, 704
      • Tainan City, Taiwan, 710
      • Taipei, Taiwan, 100
      • Taipei, Taiwan, 114
      • Taipei City, Taiwan, 11217
    • R.o. C.
      • Taichung, R.o. C., Taiwan, 40447
      • Taichung, R.o. C., Taiwan, 407
      • Taipei City, R.o. C., Taiwan, 116
  • Ukraine
      • Chernivtsi, Ukraine, 58000
      • Ivano Frakivsk, Ukraine, 76018
      • Kharkiv, Ukraine, 61103
      • Kharkiv, Ukraine, 61106
      • Kharkiv, Ukraine, 61124
      • Kherson, Ukraine, 73000
      • Kiev, Ukraine, 01133
      • Kremenchuk, Ukraine, 39617
      • Sumy, Ukraine, 40022
      • Vinnytsia, Ukraine, 21029
      • Zaporizhzhia, Ukraine, 69035
      • Zaporizhzhia, Ukraine, 69065
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
      • Mobile, Alabama, United States, 36609
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Chino, California, United States, 91710
      • Glendale, California, United States, 91206
      • Laguna Hills, California, United States, 92653
      • Los Angeles, California, United States, 90015
      • Pasadena, California, United States, 91105
      • Sacramento, California, United States, 95817
      • Sylmar, California, United States, 91342
      • Torrance, California, United States, 90502
    • Delaware
      • Newark, Delaware, United States, 19713
    • Florida
      • Bay Pines, Florida, United States, 33744
      • DeLand, Florida, United States, 32720
      • Doral, Florida, United States, 33166
      • Kissimmee, Florida, United States, 34741
      • Miami, Florida, United States, 33144
      • Miami, Florida, United States, 33156
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Augusta, Georgia, United States, 30912
      • Blue Ridge, Georgia, United States, 30513
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Springfield, Illinois, United States, 62702
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
    • Kentucky
      • Hazard, Kentucky, United States, 41701
      • Louisville, Kentucky, United States, 40202
      • Louisville, Kentucky, United States, 40206
      • Owensboro, Kentucky, United States, 42303
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
      • Shreveport, Louisiana, United States, 71103
    • Michigan
      • Detroit, Michigan, United States, 48202
      • Farmington Hills, Michigan, United States, 48334
      • Royal Oak, Michigan, United States, 48073
    • Minnesota
      • Duluth, Minnesota, United States, 55805
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Montana
      • Butte, Montana, United States, 59701
    • New Jersey
      • Newark, New Jersey, United States, 07102
      • Somers Point, New Jersey, United States, 08244
    • New York
      • Buffalo, New York, United States, 14215
      • Jamaica, New York, United States, 11418
      • Johnson City, New York, United States, 13790
      • New York, New York, United States, 10003
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Akron, Ohio, United States, 44304
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43210
      • Dayton, Ohio, United States, 45402
      • Lima, Ohio, United States, 45801
    • Pennsylvania
      • Bethleham, Pennsylvania, United States, 18015
      • Philadelphia, Pennsylvania, United States, 19141
      • Wyomissing, Pennsylvania, United States, 19610
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77024
      • Houston, Texas, United States, 77011
      • Houston, Texas, United States, 77093
      • Splendora, Texas, United States, 77372
    • Virginia
      • Charlottesville, Virginia, United States, 22905-2877
    • Washington
      • Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moxifloxacin
Intravenous with the potential step-down to oral moxifloxacin
Drug: Moxifloxacin
Other Names:
  • Avelox
Experimental: Solithromycin
Intravenous with potential step-down to oral solithromycin
Drug: Solithromycin
Other Names:
  • CEM-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early clinical response rate in the Intent to Treat (ITT) population.
Time Frame: 72 [±12] hours after the first dose of study drug
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early clinical response rate in the microITT population
Time Frame: 72 [±12] hours after the first dose of study drug
To determine NI in early clinical response rate of intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population
72 [±12] hours after the first dose of study drug
Clinical success rates in the ITT and Clinically Evaluable (CE) populations
Time Frame: 5 to 10 days after the last dose of study drug
To determine the overall clinical success rates of intravenous to oral solithromycin compared to moxifloxacin
5 to 10 days after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melinta Therapeutics, Inc.

Investigators

  • Study Director: Brian D Jamieson, MD, Melinta Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE01-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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