The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Primary Endpoints are:
* Proportion of Responders for ECR at 96 ± 24 hours following the first dose of
study drug in the ITT Analysis Set (FDA)
* Proportion of subjects with an IACR of Success at TOC in the mITT and CE-TOC
Analysis Sets (Primary for EMA and secondary for FDA)
Timepoint(s) of evaluation of this end points are:
- 96 ± 24 hours following the first dose of study drug
- 5-10 days post last dose - test of cure
Secondary outcome
The Secondary Endpoint is:
* Efficacy will be assessed by ECR, IACR and by Microbiological Response, 5-10
days post last dose - test of cure.
Background summary
Community-acquired bacterial pneumonia (CABP) is a commonly occurring serious
infection that requires systemic antibiotic therapy and is associated with
substantial morbidity, mortality, and considerable healthcare costs. In Europe,
there are 44 cases of CABP for every 1000 patients treated in a single general
practice.
The emergence of pathogens resistant to antimicrobials has become an
increasingly complicating factor in the selection of empiric therapy for CABP.
S. aureus, including methicillin-resistant S. aureus (MRSA), has emerged as an
important pathogen in CABP. Optimal management for patients with CABP caused by
MRSA is not yet clear, and even the best available treatment may still result
in poor outcomes.Therefore, there is a need for more treatment options for CABP
caused by MRSA.
Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class
known as the pleuromutilins. Both the intravenous (IV) and oral dosage forms of
lefamulin are under investigation in this study.
Study objective
The Primary Objectives for the study are:
* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with
respect to the Early Clinical Response (96 ± 24 hours after the first dose of
study drug) in the Intent to Treat (ITT) Analysis Set (FDA endpoint).
*Demonstrate the NI of lefamulin versus comparator with respect to the
Investigator*s Assessment of Clinical Response at Test of Cure (TOC) (i.e.,
5-10 days after the last dose of study drug) in the modified-ITT (mITT) and
Clinically Evaluable at TOC (CE-TOC) Analysis Sets (EMA endpoint).
Study design
A multicenter, multinational, randomized, double-blind, double-dummy, active
controlled efficacy and safety study in subjects with community-acquired
bacterial pneumonia (CABP) to be conducted at approximately 125 centers.
Intervention
Lefamulin IV 150 mg of lefamulin in 15 mL of 0.9% saline, to be further diluted
in 10mM citrate buffered 0.9% saline
PO 600 mg of lefamulin as a yellow oval film coated immediate-release
tablet
Moxifloxacin IV 400 mg of moxifloxacin in a ready-to-use latex-free flexibag
PO 400 mg of moxifloxacin as an over-encapsulated film-coated tablet
Linezolid IV 600 mg of linezolid in a ready-to-use flexible plastic
(latex-free) infusion bag
PO 600 mg of linezolid as an over-encapsulated film-coated tablet
Study burden and risks
There are possible side effects and discomforts associated with the procedures
and study treatment. Patients may experience some, all, or none of these
effects. The possible side effects and discomforts associated with study
procedures and study treatment are described in an addendum (Side effects) of
the Patient lnformation Leaflet.
There may be side effects or discomforts from the study treatment that are not
yet known.
Pregnancy Risks:
lf you are pregnant or become pregnant, there may be risks to the foetus which
are currenfly unknown.
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Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-005169-63-NL |
| ClinicalTrials.gov | NCT02559310 |
| CCMO | NL54955.015.15 |