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

NCT02679573 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: ML-3341-3062015-003026-14
• Study Type: interventional
• Target: 860
• Locations: 18 countries
• Sites: 90

Brief 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.

Conditions

Community Acquired Bacterial Pneumonia

Keywords

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  96 (+/- 24) hours after the first dose of study drug

• Clinical Outcome at Test of Cure

  5 to 10 days after the last dose of study drug

• Clinical Outcome at End of Treatment

  Up to 24 (+4) hours after the last dose of study drug

• Microbiologic Response

  5 to 10 days after the last dose of study drug

• All-cause Mortality

  Day 28 (+/- 2 days)

Study Arms (2)

Delafloxacin

EXPERIMENTAL

IV delafloxacin with potential to switch to oral delafloxacin

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

Drug: Moxifloxacin; Drug: Linezolid

Interventions

Delafloxacin DRUG

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

Also known as: RX-3341

Delafloxacin

Moxifloxacin DRUG

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

Also known as: Avelox

Moxifloxacin/Linezolid

Linezolid DRUG

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

Also known as: Zyvox

Moxifloxacin/Linezolid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (90)

Melinta 306 Study Site

Montgomery, Alabama, 36106, United States

Location

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Newark, Delaware, 19718, United States

Location

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Coral Gables, Florida, 33134, United States

Location

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DeBary, Florida, 32713, United States

Location

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DeLand, Florida, 32720, United States

Location

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Fort Myers, Florida, 33901, United States

Location

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Miami, Florida, 33126, United States

Location

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Miami, Florida, 33185, United States

Location

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Louisville, Kentucky, 40202, United States

Location

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Natchitoches, Louisiana, 71457-6215, United States

Location

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Baltimore, Maryland, 21201, United States

Location

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Boston, Massachusetts, 02115, United States

Location

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Burlington, Massachusetts, 01805, United States

Location

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Saint Paul, Minnesota, 55104, United States

Location

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St Louis, Missouri, 63110, United States

Location

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Butte, Montana, 59701, United States

Location

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Omaha, Nebraska, 68124, United States

Location

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Newark, New Jersey, 07102, United States

Location

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Buffalo, New York, 14215, United States

Location

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Charlotte, North Carolina, 28203, United States

Location

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Cleveland, Ohio, 44106-5029, United States

Location

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Dayton, Ohio, 45402, United States

Location

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Rapid City, South Dakota, 57702, United States

Location

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Franklin, Tennessee, 37067, United States

Location

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Corsicana, Texas, 75110, United States

Location

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Buenos Aires, Argentina

Location

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Córdoba, Argentina

Location

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La Plata, Argentina

Location

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Pleven, Bulgaria

Location

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Rousse, Bulgaria

Location

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Sofia, Bulgaria

Location

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Stara Zagora, Bulgaria

Location

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Barranquilla, Colombia

Location

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Cali, Colombia

Location

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Manizales, Colombia

Location

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Medellín, Colombia

Location

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Quindío, Colombia

Location

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Santo Domingo, Dominican Republic

Location

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Tbilisi, Georgia

Location

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Leverkusen, Germany

Location

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Munich, Germany

Location

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Budapest, Hungary

Location

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Debrecen, Hungary

Location

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Deszk, Hungary

Location

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Miskolc, Hungary

Location

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Nyíregyháza, Hungary

Location

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Szombathely, Hungary

Location

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Daugavpils, Latvia

Location

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Liepāja, Latvia

Location

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Riga, Latvia

Location

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Lima, Peru

Location

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Chrzanów, Poland

Location

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Katowice, Poland

Location

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Lodz, Poland

Location

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Wroclaw, Poland

Location

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Brasov, Romania

Location

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Bucharest, Romania

Location

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Craiova, Romania

Location

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Timișoara, Romania

Location

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Arkhangelsk, Russia

Location

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Moscow, Russia

Location

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Saint Petersburg, Russia

Location

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Smolensk, Russia

Location

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Vsevolozhsk, Russia

Location

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Belgrade, Serbia

Location

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Kamenitz, Serbia

Location

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Kragujevac, Serbia

Location

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Niš, Serbia

Location

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Golnik, Slovenia

Location

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Ljubljana, Slovenia

Location

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Benoni, South Africa

Location

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Chatsworth, South Africa

Location

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Krugersdorp, South Africa

Location

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Middelburg, South Africa

Location

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Phoenix, South Africa

Location

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Port Elizabeth, South Africa

Location

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Pretoria, South Africa

Location

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Worcester, South Africa

Location

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Badalona, Spain

Location

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Barcelona, Spain

Location

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Madrid, Spain

Location

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Terrassa, Spain

Location

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Valencia, Spain

Location

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Dnipro, Ukraine

Location

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Kharkiv, Ukraine

Location

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Kyiv, Ukraine

Location

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Poltava, Ukraine

Location

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Vinnytsia, Ukraine

Location

Melinta 306 Study Site

Zaporizhia, Ukraine

Location

Melinta 306 Study Site

Zhytomyr, Ukraine

Location

MeSH Terms

Conditions

Pneumonia

Interventions

delafloxacin; Moxifloxacin; Linezolid

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Sue Cammarata
• Organization: Melinta Therapeutics, Inc.

scammarata@melinta.com

312-724-9401

Study Officials

• Sue Cammarata, MD

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 10, 2016
• Study Start: December 14, 2016
• Primary Completion: July 31, 2018
• Study Completion: August 7, 2018
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (6); ZA (8); US (25); GE (1); SL (2); ES (5); UA (7); LA (3); AR (3); CO (5); SE (4); DO (1); PE (1); RU (5); BU (4); RO (4); PL (4); DE (2)