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

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

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

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)

860

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
      • Caba, Argentina, C1120AAF
      • Ciudad Autonoma de Buenos Aires, Argentina, 1426
      • Ciudad Autonoma de Buenos Aires, Argentina, C1425BEA
      • Cordoba, Argentina, X5000JRD
      • Santa Fe, Argentina, S3000EOZ
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900AVG
      • Tandil, Buenos Aires, Argentina, B7000AXD
    • Provincia de Buenos Aires
      • Loma Hermosa, Provincia de Buenos Aires, Argentina, B1657BHD
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CVB
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, T4000IAR
  • Bulgaria
      • Pernik, Bulgaria, 2300
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1336
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1709
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V1Y 1S1
    • Ontario
      • Cornwall, Ontario, Canada, K6H 4M4
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
  • Czech Republic
      • Beroun, Czech Republic, 266 01
  • Dominican Republic
      • Santo Domingo, Dominican Republic, 10205
      • Santo Domingo, Dominican Republic, 10511
  • Ecuador
      • Guayaquil, Ecuador
      • Quito, Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, EC090103
  • Estonia
      • Tallinn, Estonia, 10617
      • Tallinn, Estonia, 13619
      • Tartu, Estonia, 51014
  • Germany
      • Hannover, Germany, 30173
    • De-he
      • Hofheim, De-he, Germany, 65719
    • De-ni
      • Rotenburg (Wuemme), De-ni, Germany, 27356
  • Hungary
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1121
      • Budapest, Hungary, 1122
      • Kecskemet, Hungary, 6000
      • Nyiregyhaza, Hungary, 4400
  • Latvia
      • Daugavpils, Latvia, LV5417
      • Liepaja, Latvia, LV 3414
      • Riga, Latvia, LV-1002
      • Riga, Latvia, LV-1057
  • Poland
      • Krakow, Poland, 31011
      • Lodz, Poland, 90153
      • Lublin, Poland, 20090
      • Zgierz, Poland, 95100
  • Puerto Rico
      • San Juan, Puerto Rico, 00921
  • Romania
      • Bucharest, Romania, 010825
      • Bucharest, Romania, 021659
      • Bucharest, Romania, 030303
      • Craiova, Romania, 200515
      • Iasi, Romania, 700115
      • Timisoara, Romania, 300310
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454008
      • Moscow, Russian Federation, 111539
      • Moscow, Russian Federation, 109240
      • Moscow, Russian Federation, 115446
      • Moscow, Russian Federation, 119991
      • Moscow, Russian Federation, 123182
      • Moscow, Russian Federation, 125206
      • Moscow, Russian Federation, 125284
      • Smolensk, Russian Federation, 214019
      • St Petersburg, Russian Federation, 193312
      • St. Petersburg, Russian Federation, 197022
      • St. Petersburg, Russian Federation, 192242
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 195271
      • St. Petersburg, Russian Federation, 196247
      • St. Petersburg, Russian Federation, 199106
    • Leningrad Region
      • St Petersburg, Leningrad Region, Russian Federation, 194354
      • St Petersburg, Leningrad Region, Russian Federation, 196211
      • St Petersburg, Leningrad Region, Russian Federation, 198205
    • Smolensk Region
      • Smolensk, Smolensk Region, Russian Federation, 214019
  • South Africa
      • Benoni, South Africa, 1500
      • Bloemfontein, South Africa, 9300
      • Cape Town, South Africa, 7530
      • Cape Town, South Africa, 7570
      • Cape Town, South Africa, 7764
      • Krugersdorp, South Africa, 1739
      • Pretoria, South Africa, 0001
      • Worcester, South Africa, 6850
    • Limpopo
      • Thabazimbi, Limpopo, South Africa, 0380
    • Midrand
      • Halfway House, Midrand, South Africa, 1685
    • Mpumalanga
      • Middelburg, Mpumalanga, South Africa, 1055
      • Witbank, Mpumalanga, South Africa, 1035
    • Port Elizabeth
      • Korsten, Port Elizabeth, South Africa, 6014
    • Pretoria
      • Hillcrest, Pretoria, South Africa, 0083
  • Spain
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28046
      • Madrid, Spain, 28850
      • Mataro, Spain, 08304
      • Valencia, Spain, 46026
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
  • United States
    • California
      • Glendale, California, United States, 91206
      • Los Angeles, California, United States, 90015
      • Mission Hills, California, United States, 91345
      • Oxnard, California, United States, 93030
      • Pasadena, California, United States, 91105
      • Sylmar, California, United States, 91342
      • Torrance, California, United States, 90502
    • Florida
      • DeLand, Florida, United States, 32720
      • Debary, Florida, United States, 32713
      • Miami, Florida, United States, 33126
      • Miami, Florida, United States, 33144
      • St Cloud, Florida, United States, 34769
      • Tampa, Florida, United States, 33606
    • Georgia
      • Duluth, Georgia, United States, 30096
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
    • Montana
      • Butte, Montana, United States, 59701
    • Ohio
      • Columbus, Ohio, United States, 43035
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
    • South Carolina
      • Summerville, South Carolina, United States, 29485
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77070
      • Houston, Texas, United States, 77011
      • Houston, Texas, United States, 77093
      • Splendora, Texas, United States, 77372

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

18 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

  • 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

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
Experimental: Solithromycin
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 Names:
  • CEM-101
Other: Placebo to match solithromycin
Active Comparator: Moxifloxacin
Moxifloxacin 400 mg PO daily on Day 1 through Day 7
Drug: Moxifloxacin
Other Names:
  • Avelox

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 oral solithromycin compared to oral moxifloxacin in the mITT population
72 [±12] hours after the first dose of study drug
Clinical success rates in the ITT and Clincally Evaluable (CE) populations
Time Frame: 5 to 10 days after the last dose of study drug
To determine the overall clinical success rates of 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: David Oldach, 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

December 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 25, 2012

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

  • CE01-300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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