A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Lefamulin (BC 3781) Versus Moxifloxacin (With or Without Adjunctive Linezolid) in Adults With Community-Acquired Bacterial Pneumonia

Phase 3

Completed

Conditions: A lung infection obtained in your daily life
such as at school or work
10024970

Registration Number: NL-OMON43840

Lead Sponsor: abriva Therapeutics AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

- 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;- Have at least 2 of the following vital sign abnormalities:
* Fever (body temperature >38.0°C) or hypothermia (body temperature <35.0°C)
* Hypotension (systolic blood pressure <90 mmHg)
* Tachycardia (heart rate >100 beats/min)
* Tachypnea (respiratory rate >20 breaths/min);- Have at least 1 other clinical sign or laboratory finding of CABP:
* Hypoxemia
* Auscultatory and/or percussion findings consistent with pneumonia
* White blood cell count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count

Exclusion Criteria

- Subject must not have received more than a single dose of a short-acting oral or IV antibacterial for CABP *24 hrs before randomization (for exceptions, see the study protocol).;- Subject should not require concomitant systemic antibacterial therapy potentially effective against CABP pathogens.;- Subject should not 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Primary Endpoints are:<br /><br><br /><br>* Proportion of Responders for ECR at 96 ± 24 hours following the first dose of<br /><br>study drug in the ITT Analysis Set (FDA)<br /><br>* Proportion of subjects with an IACR of Success at TOC in the mITT and CE-TOC<br /><br>Analysis Sets (Primary for EMA and secondary for FDA)<br /><br><br /><br>Timepoint(s) of evaluation of this end points are:<br /><br>- 96 ± 24 hours following the first dose of study drug<br /><br>- 5-10 days post last dose - test of cure<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Secondary Endpoint is:<br /><br><br /><br>* Efficacy will be assessed by ECR, IACR and by Microbiological Response, 5-10<br /><br>days post last dose - test of cure.<br /><br><br /><br></p><br>