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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
860

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Melinta Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 25, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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