A Clinical Study to Compare the effectiveness and safety of Lefamulin (BC 3781) Versus Moxifloxacin (With or Without added Linezolid) in Adults With Community-Acquired Bacterial Pneumonia

Phase 1

• Conditions: Community-Acquired Bacterial Pneumonia; MedDRA version: 18.1Level: LLTClassification code 10004051Term: Bacterial pneumonia, unspecifiedSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-005169-63-BG
• Lead Sponsor: abriva Therapeutics AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-23
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 738

Inclusion Criteria

1. Be male or female at least 18 years of age.
2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.
3. Have an acute illness (7 days or less duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening):
• Dyspnea.
• New or increased cough.
• Purulent sputum production.
• Chest pain due to pneumonia.
4. Have at least 2 of the following vital sign abnormalities:
• Fever (body temperature >38.0°C (100.4°F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature <35.0°C (95.0°F) measured orally or equivalent temperature from an alternate body site).
• Hypotension (systolic blood pressure <90 mmHg).
• Tachycardia (heart rate >100 beats/min).
• Tachypnea (respiratory rate >20 breaths/min).
5. Have at least 1 other clinical sign or laboratory finding of CABP:
• Hypoxemia (i.e., O2 saturation <90% on room air or while receiving supplemental oxygen at subject’s baseline requirement or PaO2 <60 mmHg).
• Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness).
• White blood cell (WBC) count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count.
6. Have radiographically-documented pneumonia within 24 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia).
7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class =III.
8. If female, meets the following criteria:
• Surgically sterile or =2 years postmenopausal, or if of childbearing potential (including being <2 years postmenopausal), has a negative pregnancy test, and if participating in sexual activity that may lead to pregnancy, agrees to use an effective dual method of contraception (e.g., condom plus diaphragm, condom plus spermicide, intrauterine device plus spermicide, oral contraceptive plus condom) during the study and for =28 days after the last dose of study drug. If a male partner has been surgically sterile for =1 year, a single contraception method may be used.
• Agrees not to breastfeed during the study and through =28 days after the last dose of study drug.
9. If male, meets the following criteria:
• If not surgically sterile and if participating in sexual activity that may lead to pregnancy, agrees to use an effective dual method of contraception (e.g., condom plus diaphragm, condom plus spermicide, intrauterine device plus spermicide, oral contraceptive plus condom) during the study and through =28 days after the last dose of study drug. If surgically sterile for =1 year, a single contraception method may be used.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 738
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 738

Exclusion Criteria

Each subject must NOT:
1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP =24 hrs before randomization
• EXCEPTION: Subjects who have received >48 hrs of prior systemic antibacterial therapy for current episode of CABP with unequivocal clinical evidence of treatment failure and isolation of an organism from blood or respiratory tract that is resistant to the prior systemic antibacterial therapy unless the resistance is to fluoroquinolones and, in the case of MRSA, oxazolidinones.
2. Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens.
3. Have been hospitalized for =2 days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms.
4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung).
5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis).
6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).
7. Require mechanical ventilation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified