Community Acquired Bacterial PneumoniaPhase 3DEFINE-CABPNCT02679573

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

A Phase 3 study testing Delafloxacin, Moxifloxacin and Linezolid in people with Community Acquired Bacterial Pneumonia, run by Melinta Therapeutics, Inc. at 90 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Community Acquired Bacterial Pneumonia
What is being tested?: Delafloxacin, Moxifloxacin and Linezolid
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 860 participants
Where: 90 sitesin 18 countries
Study dates: 14 Dec 2016to 7 Aug 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female 18 years of age or older
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

Show all 18Show fewer

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
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
PORT risk class of II to V (PSI score >50)
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

Who cannot join

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
Any infection expected to require other systemic antibiotics in addition to study drug
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)
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

Show all 12Show fewer

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)
Known anatomical or pathological bronchial obstruction OR history of bronchiectasis OR GOLD Stage 4 COPD OR history of post obstructive pneumonia
Severely compromised immune system
Known history of Child-Pugh Class B or C liver disease
History of post-antibiotic colitis within last 3 months
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

Trial locations and contacts

90 sites in 18 countries.

Country

City, postcode or hospital

90 sites in 18 countries

United States25 sites

Melinta 306 Study Site
Baltimore, Maryland, 21201
Melinta 306 Study Site
Boston, Massachusetts, 02115
Melinta 306 Study Site
Buffalo, New York, 14215
Melinta 306 Study Site
Burlington, Massachusetts, 01805
Melinta 306 Study Site
Butte, Montana, 59701
Melinta 306 Study Site
Charlotte, North Carolina, 28203
Melinta 306 Study Site
Cleveland, Ohio, 44106-5029
Melinta 306 Study Site
Coral Gables, Florida, 33134
Melinta 306 Study Site
Corsicana, Texas, 75110
Melinta 306 Study Site
Dayton, Ohio, 45402
Melinta 306 Study Site
DeBary, Florida, 32713
Melinta 306 Study Site
DeLand, Florida, 32720
Melinta 306 Study Site
Fort Myers, Florida, 33901
Melinta 306 Study Site
Franklin, Tennessee, 37067
Melinta 306 Study Site
Louisville, Kentucky, 40202
Melinta 306 Study Site
Miami, Florida, 33126
Melinta 306 Study Site
Miami, Florida, 33185
Melinta 306 Study Site
Montgomery, Alabama, 36106
Melinta 306 Study Site
Natchitoches, Louisiana, 71457-6215
Melinta 306 Study Site
Newark, Delaware, 19718
Melinta 306 Study Site
Newark, New Jersey, 07102
Melinta 306 Study Site
Omaha, Nebraska, 68124
Melinta 306 Study Site
Rapid City, South Dakota, 57702
Melinta 306 Study Site
Saint Paul, Minnesota, 55104
Melinta 306 Study Site
St Louis, Missouri, 63110

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South Africa8 sites

Melinta 306 Study Site
Benoni
Melinta 306 Study Site
Chatsworth
Melinta 306 Study Site
Krugersdorp
Melinta 306 Study Site
Middelburg
Melinta 306 Study Site
Phoenix
Melinta 306 Study Site
Port Elizabeth
Melinta 306 Study Site
Pretoria
Melinta 306 Study Site
Worcester

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Ukraine7 sites

Melinta 306 Study Site
Dnipro
Melinta 306 Study Site
Kharkiv
Melinta 306 Study Site
Kyiv
Melinta 306 Study Site
Poltava
Melinta 306 Study Site
Vinnytsia
Melinta 306 Study Site
Zaporizhia
Melinta 306 Study Site
Zhytomyr

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Hungary6 sites

Melinta 306 Study Site
Budapest
Melinta 306 Study Site
Debrecen
Melinta 306 Study Site
Deszk
Melinta 306 Study Site
Miskolc
Melinta 306 Study Site
Nyíregyháza
Melinta 306 Study Site
Szombathely

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Colombia5 sites

Melinta 306 Study Site
Barranquilla
Melinta 306 Study Site
Cali
Melinta 306 Study Site
Manizales
Melinta 306 Study Site
Medellín
Melinta 306 Study Site
Quindío

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Russia5 sites

Melinta 306 Study Site
Arkhangelsk
Melinta 306 Study Site
Moscow
Melinta 306 Study Site
Saint Petersburg
Melinta 306 Study Site
Smolensk
Melinta 306 Study Site
Vsevolozhsk

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Spain5 sites

Melinta 306 Study Site
Badalona
Melinta 306 Study Site
Barcelona
Melinta 306 Study Site
Madrid
Melinta 306 Study Site
Terrassa
Melinta 306 Study Site
Valencia

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Bulgaria4 sites

Melinta 306 Study Site
Pleven
Melinta 306 Study Site
Rousse
Melinta 306 Study Site
Sofia
Melinta 306 Study Site
Stara Zagora

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Poland4 sites

Melinta 306 Study Site
Chrzanów
Melinta 306 Study Site
Katowice
Melinta 306 Study Site
Lodz
Melinta 306 Study Site
Wroclaw

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Romania4 sites

Melinta 306 Study Site
Brasov
Melinta 306 Study Site
Bucharest
Melinta 306 Study Site
Craiova
Melinta 306 Study Site
Timișoara

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Serbia4 sites

Melinta 306 Study Site
Belgrade
Melinta 306 Study Site
Kamenitz
Melinta 306 Study Site
Kragujevac
Melinta 306 Study Site
Niš

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Argentina3 sites

Melinta 306 Study Site
Buenos Aires
Melinta 306 Study Site
Córdoba
Melinta 306 Study Site
La Plata

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Latvia3 sites

Melinta 306 Study Site
Daugavpils
Melinta 306 Study Site
Liepāja
Melinta 306 Study Site
Riga

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Germany2 sites

Melinta 306 Study Site
Leverkusen
Melinta 306 Study Site
Munich

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Slovenia2 sites

Melinta 306 Study Site
Golnik
Melinta 306 Study Site
Ljubljana

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Dominican Republic1 site

Melinta 306 Study Site
Santo Domingo

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Georgia1 site

Melinta 306 Study Site
Tbilisi

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Peru1 site

Melinta 306 Study Site
Lima

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About this study

Official title: 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.

Read the 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.

Conditions: Community Acquired Bacterial Pneumonia
Being tested: Delafloxacin, Moxifloxacin, Linezolid
Keywords: Pneumonia
Medical subject headings: Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DelafloxacinDrug
Also called RX-3341
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
MoxifloxacinDrug
Also called Avelox
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
LinezolidDrug
Also called Zyvox
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

Study groups in NCT02679573
Study group	Role	What they receive
Delafloxacin	Experimental	IV delafloxacin with potential to switch to oral delafloxacin Receives: Drug: Delafloxacin
Moxifloxacin/Linezolid	Active comparator	IV moxifloxacin with potential to switch to oral moxifloxacin, and potential to switch moxifloxacin to IV linezolid for confirmed MRSA Receives: Drug: Moxifloxacin; Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

Early Clinical Response
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.
Measured: 96 (+/- 24) hours after the first dose of study drug

Secondary outcomes (5)

Early Clinical Response Plus Improvement in Vital Signs and no Worsening of the 4 Symptoms
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.
Measured: 96 (+/- 24) hours after the first dose of study drug
Clinical Outcome at Test of Cure
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.
Measured: 5 to 10 days after the last dose of study drug
Clinical Outcome at End of Treatment
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.
Measured: Up to 24 (+4) hours after the last dose of study drug
Microbiologic Response
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.
Measured: 5 to 10 days after the last dose of study drug
All-cause Mortality
Time to all-cause Mortality was assessed on Day 28.
Measured: Day 28 (+/- 2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 20167 Aug 2018

First posted10 Feb 2016 (estimated)
Study start14 Dec 2016
Primary completion31 Jul 2018
Study completion7 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Community Acquired Bacterial PneumoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 860 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02679573
Sponsor's protocol ID: ML-3341-306
Other IDs: 2015-003026-14, 2015
Acronym: DEFINE-CABP
Status last verified: Feb 2020
First submitted: 27 Jan 2016
Last updated: 27 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Community Acquired Bacterial Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02679573
Acronym / sponsor ID: DEFINE-CABP / ML-3341-306
Conditions: Community Acquired Bacterial Pneumonia
Keywords: Pneumonia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 860 participants (actual)
Lead sponsor: Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 14 Dec 2016 (actual)
Primary completion: 31 Jul 2018 (actual)
Study completion: 7 Aug 2018 (actual)
First posted: 10 Feb 2016 (estimated)
Results: Posted 27 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Delafloxacin	Experimental	Drug: DelafloxacinIV delafloxacin with potential to switch to oral delafloxacin
Moxifloxacin/Linezolid	Active comparator	Drug: Moxifloxacin, Drug: LinezolidIV moxifloxacin with potential to switch to oral moxifloxacin, and potential to switch moxifloxacin to IV linezolid for confirmed MRSA

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Male or female 18 years of age or older
Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening)
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
PORT risk class of II to V (PSI score >50)
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

Key exclusion criteria (12 listed)

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
Any infection expected to require other systemic antibiotics in addition to study drug
Receipt of systemic antibiotic therapy in the 7 days before enrollment unless 1 of the following is documented:
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
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DelafloxacinAlso: RX-3341Antibacterial 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	Drug	Delafloxacin
MoxifloxacinAlso: AveloxAntibacterial 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	Drug	Moxifloxacin/Linezolid
LinezolidAlso: ZyvoxAntibacterial 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	Drug	Moxifloxacin/Linezolid

Primary outcome

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.

5 secondary outcomes

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
Clinical Outcome at Test of Cure
Time frame: 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
Microbiologic Response
Time frame: 5 to 10 days after the last dose of study drug
All-cause Mortality
Time frame: Day 28 (+/- 2 days)

Results and safety

Results posted to the registry on 27 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delafloxacin	431	394
Moxifloxacin/Linezolid	428	389

Primary outcome: Early Clinical Response

Time frame: 96 (+/- 24) hours after the first dose of study drug. Count of participants. Unit: Participants

Measure	Delafloxacin n = 431	Moxifloxacin/Linezolid n = 428
Value	383	381

Delafloxacin vs Moxifloxacin/Linezolid: Difference in responder rates: -0.2 (95% CI -4.4 to 4.1)

Population analysed: ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delafloxacin	23 of 429 (5.4%)	40 of 429 (9.3%)	8 of 429
Moxifloxacin/Linezolid	20 of 427 (4.7%)	30 of 427 (7%)	6 of 427

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sue Cammarata, MD study director

Melinta Therapeutics, Inc.

90 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Delafloxacin, Moxifloxacin and Linezolid in people with Community Acquired Bacterial Pneumonia, run by Melinta Therapeutics, Inc. at 90 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, South Africa, Ukraine, Hungary, Colombia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early Clinical Response (time frame: 96 (+/- 24) hours after the first dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02679573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.