Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia (DEFINE-CABP)

February 14, 2020 updated by: Melinta Therapeutics, Inc.

A Phase 3, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety and Efficacy of Intravenous to Oral Delafloxacin in Adult Subjects With Community-Acquired Bacterial Pneumonia

The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to moxifloxacin 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

The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of community-acquired bacterial pneumonia compared with moxifloxacin, or linezolid in the case of confirmed MRSA.

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
      • Buenos Aires, Argentina
        • Melinta 306 Study Site
      • Córdoba, Argentina
        • Melinta 306 Study Site
      • La Plata, Argentina
        • Melinta 306 Study Site
  • Bulgaria
      • Pleven, Bulgaria
        • Melinta 306 Study Site
      • Ruse, Bulgaria
        • Melinta 306 Study Site
      • Sofia, Bulgaria
        • Melinta 306 Study Site
      • Stara Zagora, Bulgaria
        • Melinta 306 Study Site
  • Colombia
      • Barranquilla, Colombia
        • Melinta 306 Study Site
      • Cali, Colombia
        • Melinta 306 Study Site
      • Manizales, Colombia
        • Melinta 306 Study Site
      • Medellín, Colombia
        • Melinta 306 Study Site
      • Quindío, Colombia
        • Melinta 306 Study Site
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Melinta 306 Study Site
  • Georgia
      • Tbilisi, Georgia
        • Melinta 306 Study Site
  • Germany
      • Leverkusen, Germany
        • Melinta 306 Study Site
      • Munich, Germany
        • Melinta 306 Study Site
  • Hungary
      • Budapest, Hungary
        • Melinta 306 Study Site
      • Debrecen, Hungary
        • Melinta 306 Study Site
      • Deszk, Hungary
        • Melinta 306 Study Site
      • Miskolc, Hungary
        • Melinta 306 Study Site
      • Nyíregyháza, Hungary
        • Melinta 306 Study Site
      • Szombathely, Hungary
        • Melinta 306 Study Site
  • Latvia
      • Daugavpils, Latvia
        • Melinta 306 Study Site
      • Liepaja, Latvia
        • Melinta 306 Study Site
      • Riga, Latvia
        • Melinta 306 Study Site
  • Peru
      • Lima, Peru
        • Melinta 306 Study Site
  • Poland
      • Chrzanow, Poland
        • Melinta 306 Study Site
      • Katowice, Poland
        • Melinta 306 Study Site
      • Lodz, Poland
        • Melinta 306 Study Site
      • Wroclaw, Poland
        • Melinta 306 Study Site
  • Romania
      • Braşov, Romania
        • Melinta 306 Study Site
      • Bucharest, Romania
        • Melinta 306 Study Site
      • Craiova, Romania
        • Melinta 306 Study Site
      • Timisoara, Romania
        • Melinta 306 Study Site
  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Melinta 306 Study Site
      • Moscow, Russian Federation
        • Melinta 306 Study Site
      • Smolensk, Russian Federation
        • Melinta 306 Study Site
      • St. Petersburg, Russian Federation
        • Melinta 306 Study Site
      • Vsevolozhsk, Russian Federation
        • Melinta 306 Study Site
  • Serbia
      • Belgrade, Serbia
        • Melinta 306 Study Site
      • Kragujevac, Serbia
        • Melinta 306 Study Site
      • Nis, Serbia
        • Melinta 306 Study Site
      • Sremska Kamenica, Serbia
        • Melinta 306 Study Site
  • Slovenia
      • Golnik, Slovenia
        • Melinta 306 Study Site
      • Ljubljana, Slovenia
        • Melinta 306 Study Site
  • South Africa
      • Benoni, South Africa
        • Melinta 306 Study Site
      • Chatsworth, South Africa
        • Melinta 306 Study Site
      • Krugersdorp, South Africa
        • Melinta 306 Study Site
      • Middelburg, South Africa
        • Melinta 306 Study Site
      • Phoenix, South Africa
        • Melinta 306 Study Site
      • Port Elizabeth, South Africa
        • Melinta 306 Study Site
      • Pretoria, South Africa
        • Melinta 306 Study Site
      • Worcester, South Africa
        • Melinta 306 Study Site
  • Spain
      • Badalona, Spain
        • Melinta 306 Study Site
      • Barcelona, Spain
        • Melinta 306 Study Site
      • Madrid, Spain
        • Melinta 306 Study Site
      • Terrassa, Spain
        • Melinta 306 Study Site
      • Valencia, Spain
        • Melinta 306 Study Site
  • Ukraine
      • Dnipro, Ukraine
        • Melinta 306 Study Site
      • Kharkiv, Ukraine
        • Melinta 306 Study Site
      • Kyiv, Ukraine
        • Melinta 306 Study Site
      • Poltava, Ukraine
        • Melinta 306 Study Site
      • Vinnytsia, Ukraine
        • Melinta 306 Study Site
      • Zaporizhia, Ukraine
        • Melinta 306 Study Site
      • Zhytomyr, Ukraine
        • Melinta 306 Study Site
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Melinta 306 Study Site
    • Delaware
      • Newark, Delaware, United States, 19718
        • Melinta 306 Study Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Melinta 306 Study Site
      • DeBary, Florida, United States, 32713
        • Melinta 306 Study Site
      • DeLand, Florida, United States, 32720
        • Melinta 306 Study Site
      • Fort Myers, Florida, United States, 33901
        • Melinta 306 Study Site
      • Miami, Florida, United States, 33126
        • Melinta 306 Study Site
      • Miami, Florida, United States, 33185
        • Melinta 306 Study Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Melinta 306 Study Site
    • Louisiana
      • Natchitoches, Louisiana, United States, 71457-6215
        • Melinta 306 Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Melinta 306 Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Melinta 306 Study Site
      • Burlington, Massachusetts, United States, 01805
        • Melinta 306 Study Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55104
        • Melinta 306 Study Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Melinta 306 Study Site
    • Montana
      • Butte, Montana, United States, 59701
        • Melinta 306 Study Site
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Melinta 306 Study Site
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Melinta 306 Study Site
    • New York
      • Buffalo, New York, United States, 14215
        • Melinta 306 Study Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Melinta 306 Study Site
    • Ohio
      • Cleveland, Ohio, United States, 44106-5029
        • Melinta 306 Study Site
      • Dayton, Ohio, United States, 45402
        • Melinta 306 Study Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Melinta 306 Study Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Melinta 306 Study Site
    • Texas
      • Corsicana, Texas, United States, 75110
        • Melinta 306 Study Site

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female 18 years of age or older

  2. Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening)

    • Cough
    • Production of purulent sputum consistent with bacterial infection
    • Difficulty breathing
    • Chest pain due to pneumonia

    AND have at least 2 of the following findings:

    • Fever (oral temperature >38.0°C)
    • Hypothermia (oral temperature <35.0°C)
    • Tachycardia (heart rate >100 beats/min)
    • Tachypnea (respiratory rate >18 breaths/min)

    AND have at least 1 of the following findings:

    • Hypoxemia (oxygen saturation <90% or PaO2 < 60 mmHg) on room air or with subject's baseline (pre-CABP under study) supplemental oxygen
    • Clinical evidence of pulmonary consolidation and/or presence of pulmonary rales
    • An elevated white blood cell count (WBC) >10,000/mm3 or 15% immature neutrophils (bands), regardless of total peripheral WBC count or leukopenia with WBC <4500/mm^3
  3. Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study within 48 hours before the first dose of study drug
  4. PORT risk class of II to V (PSI score >50)
  5. Must be a suitable candidate for possible IV to oral switch antibiotic therapy and must also be able to swallow large tablets/capsules intact without crushing

Exclusion Criteria:

  1. A medical history of significant hypersensitivity or allergic reaction to antibiotics of the quinolone or oxazolidinone class or study drug excipients according to the investigator
  2. Any infection expected to require other systemic antibiotics in addition to study drug

  3. Receipt of systemic antibiotic therapy in the 7 days before enrollment unless 1 of the following is documented:

    • Received at least 48 hours of antibiotic therapy for CABP and clinic notes document treatment failure (i.e., not by patient history or pulmonary imaging alone) with new or worsening symptoms while on pre-study therapy
    • Received 1 dose of a single, potentially effective, short-acting antibacterial drug or drug regimen for CABP within 24 hours before enrollment (limited to 25% of enrolled patients)
  4. Respiratory infection confirmed or suspected to be secondary to hospital-acquired or ventilator-associated pneumonia OR requires treatment in an intensive care setting, OR requires mechanical ventilation
  5. Current or suspected diagnosis of viral, fungal, or aspiration pneumonia, noninfectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis, empyema (not including sterile parapneumonic effusions)
  6. Known anatomical or pathological bronchial obstruction OR history of bronchiectasis OR GOLD Stage 4 COPD OR history of post obstructive pneumonia
  7. Severely compromised immune system
  8. Known history of Child-Pugh Class B or C liver disease
  9. History of post-antibiotic colitis within last 3 months
  10. Other exclusions include those described in the safety label for drugs in the quinolone and/or oxazolidinone classes such as QT prolongation, proarrhythmic conditions, concomitant use of drugs known to cause QT prolongation, peripheral neuropathy, tendon disorders, history of myasthenia gravis, liver disease, severe renal disease, seizures and concomitant use of MAO A or B inhibitor agents and adrenergic serotonergic agents

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: Triple

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: Delafloxacin
IV delafloxacin with potential to switch to oral delafloxacin
Drug: Delafloxacin
Antibacterial agent, 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
Other Names:
  • RX-3341
Active Comparator: Moxifloxacin/Linezolid
IV moxifloxacin with potential to switch to oral moxifloxacin, and potential to switch moxifloxacin to IV linezolid for confirmed MRSA
Drug: Moxifloxacin
Antibacterial Agent, 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total
Other Names:
  • Avelox
Drug: Linezolid
Antibacterial Agent, at local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Other Names:
  • Zyvox

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
Time Frame: 96 (+/- 24) hours after the first dose of study drug
Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline.
96 (+/- 24) 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 Plus Improvement in Vital Signs and no Worsening of the 4 Symptoms
Time Frame: 96 (+/- 24) hours after the first dose of study drug
Early clinical response with the addition of improvement in vital signs and no worsening of the following 4 symptoms: chest pain, cough, productive sputum, and difficulty breathing in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline. Improvement in vital signs defined as a return to normal of any abnormal vital signs at baseline, and no worsening (ie, be abnormal) of any vital sign that was normal at baseline.
96 (+/- 24) hours after the first dose of study drug
Clinical Outcome at Test of Cure
Time Frame: 5 to 10 days after the last dose of study drug
Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the ITT population.
5 to 10 days after the last dose of study drug
Clinical Outcome at End of Treatment
Time Frame: Up to 24 (+4) hours after the last dose of study drug
Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the ITT population.
Up to 24 (+4) hours after the last dose of study drug
Microbiologic Response
Time Frame: 5 to 10 days after the last dose of study drug
Microbiological response for subjects in the MITT set will be based on results of the baseline and follow-up cultures and susceptibility testing or serology.
5 to 10 days after the last dose of study drug
All-cause Mortality
Time Frame: Day 28 (+/- 2 days)
Time to all-cause Mortality was assessed on Day 28.
Day 28 (+/- 2 days)

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.

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 (Actual)

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 14, 2016

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.
July 31, 2018

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.
August 7, 2018

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).
January 27, 2016

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.
February 5, 2016

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.
February 10, 2016

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.
February 27, 2020

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.
February 14, 2020

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.
February 1, 2020

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.
  • ML-3341-306
  • 2015-003026-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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