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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02679573
Other study ID # ML-3341-306
Secondary ID 2015-003026-14
Status Completed
Phase Phase 3
First received
Last updated
Start date December 14, 2016
Est. completion date August 7, 2018

Study information

Verified date February 2020
Source Melinta Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 860
Est. completion date August 7, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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
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

Locations

Country Name City State
Argentina Melinta 306 Study Site Buenos Aires
Argentina Melinta 306 Study Site Córdoba
Argentina Melinta 306 Study Site La Plata
Bulgaria Melinta 306 Study Site Pleven
Bulgaria Melinta 306 Study Site Ruse
Bulgaria Melinta 306 Study Site Sofia
Bulgaria Melinta 306 Study Site Stara Zagora
Colombia Melinta 306 Study Site 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
Dominican Republic Melinta 306 Study Site Santo Domingo
Georgia Melinta 306 Study Site Tbilisi
Germany Melinta 306 Study Site Leverkusen
Germany Melinta 306 Study Site Munich
Hungary Melinta 306 Study Site 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
Latvia Melinta 306 Study Site Daugavpils
Latvia Melinta 306 Study Site Liepaja
Latvia Melinta 306 Study Site Riga
Peru Melinta 306 Study Site Lima
Poland Melinta 306 Study Site Chrzanow
Poland Melinta 306 Study Site Katowice
Poland Melinta 306 Study Site Lodz
Poland Melinta 306 Study Site Wroclaw
Romania Melinta 306 Study Site Brasov
Romania Melinta 306 Study Site Bucharest
Romania Melinta 306 Study Site Craiova
Romania Melinta 306 Study Site Timisoara
Russian Federation Melinta 306 Study Site 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
Serbia Melinta 306 Study Site Belgrade
Serbia Melinta 306 Study Site Kragujevac
Serbia Melinta 306 Study Site Nis
Serbia Melinta 306 Study Site Sremska Kamenica
Slovenia Melinta 306 Study Site Golnik
Slovenia Melinta 306 Study Site Ljubljana
South Africa Melinta 306 Study Site 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
Spain Melinta 306 Study Site 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
Ukraine Melinta 306 Study Site 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
United States Melinta 306 Study Site Baltimore Maryland
United States Melinta 306 Study Site Boston Massachusetts
United States Melinta 306 Study Site Buffalo New York
United States Melinta 306 Study Site Burlington Massachusetts
United States Melinta 306 Study Site Butte Montana
United States Melinta 306 Study Site Charlotte North Carolina
United States Melinta 306 Study Site Cleveland Ohio
United States Melinta 306 Study Site Coral Gables Florida
United States Melinta 306 Study Site Corsicana Texas
United States Melinta 306 Study Site Dayton Ohio
United States Melinta 306 Study Site DeBary Florida
United States Melinta 306 Study Site DeLand Florida
United States Melinta 306 Study Site Fort Myers Florida
United States Melinta 306 Study Site Franklin Tennessee
United States Melinta 306 Study Site Louisville Kentucky
United States Melinta 306 Study Site Miami Florida
United States Melinta 306 Study Site Miami Florida
United States Melinta 306 Study Site Montgomery Alabama
United States Melinta 306 Study Site Natchitoches Louisiana
United States Melinta 306 Study Site Newark Delaware
United States Melinta 306 Study Site Newark New Jersey
United States Melinta 306 Study Site Omaha Nebraska
United States Melinta 306 Study Site Rapid City South Dakota
United States Melinta 306 Study Site Saint Louis Missouri
United States Melinta 306 Study Site Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Melinta Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Colombia,  Dominican Republic,  Georgia,  Germany,  Hungary,  Latvia,  Peru,  Poland,  Romania,  Russian Federation,  Serbia,  Slovenia,  South Africa,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 96 (+/- 24) hours after the first dose of study drug
Secondary 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. 5 to 10 days after the last dose of study drug
Secondary 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. Up to 24 (+4) hours after the last dose of study drug
Secondary 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. 5 to 10 days after the last dose of study drug
Secondary All-cause Mortality Time to all-cause Mortality was assessed on Day 28. Day 28 (+/- 2 days)
See also
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