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Community Acquired PneumoniaPhase 3LEAPNCT02559310

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

A Phase 3 study testing lefamulin, Moxifloxacin and Linezolid in people with Community Acquired Pneumonia, run by Nabriva Therapeutics AG at 99 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Community Acquired Pneumonia
What is being tested?
lefamulin, Moxifloxacin and Linezolid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
551 participants
Where
99 sitesin 18 countries
Study dates
Sep 2015to May 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be male or female at least 18 years of age.
  • Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.
  • Have an acute illness (7 days 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
Show all 18Show fewer
  • Chest pain due to pneumonia
  • 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)
  • 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
  • Have radiographically-documented pneumonia within 48 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).
  • Have a Pneumonia Outcomes Research Team (PORT) Risk Class ≥III.

Who cannot join

  • Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization
  • Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens
  • Have been hospitalized for 2 or more 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. NOTE: Residence in an independent living facility is permitted.
  • Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) 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).
  • 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).
  • Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).
  • Require mechanical ventilation.

Trial locations and contacts

99 sites in 18 countries.

99 sites in 18 countries

Bulgaria12 sites

  • Site 4105

    Gabrovo, 5300

  • Site 4107

    Lovech, 5500

  • Site 4112

    Pernik, 2300

  • Site 4103

    Rousse, 7002

  • Site 4108

    Smolyan, 4700

  • Site 4102

    Sofia, 1202

  • Site 4101

    Sofia, 1233

  • Site 4106

    Sofia, 1233

  • Site 4110

    Sofia, 1606

  • Site 4111

    Sofia, 1606

  • Site 4104

    Veliko Tarnovo, 5000

  • Site 4109

    Vidin, 3700

Other trials in Bulgaria

Ukraine12 sites

  • Site 5203

    Chernivtsi, Chernivtsi Oblast, 58005

  • Site 5204

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Site 5201

    Kharkiv, Kharkiv Oblast, 61124

  • Site 5209

    Kherson, Kherson Oblast, 73000

  • Site 5202

    Kyiv, 01133

  • Site 5205

    Kyiv, 03680

  • Site 5207

    Kyiv, 03680

  • Site 5211

    Odesa, Odesa Oblast, 65025

  • Site 5208

    Sumy, 40022

  • Site 5210

    Zaporizhzhya, Zaporizhzhia Oblast, 69118

  • Site 5212

    Zaporizhzhya, 69035

  • Site 5206

    Zhytomyr, 10002

Other trials in Ukraine

Romania9 sites

  • Site 4810

    Bucharest, 030303

  • Site 4801

    Bucharest, 21105

  • Site 4806

    Bucharest, 21105

  • Site 4811

    Cluj-Napoca, 040000

  • Site 4803

    Craiova, 200515

  • Site 4808

    Craiova, 200515

  • Site 4802

    Palazu Mare, Constanța County, 900002

  • Site 4807

    Timișoara, 300310

  • Site 4809

    Timișoara, 300310

Other trials in Romania

United States7 sites

  • Site 1009

    Akron, Ohio, 44309

  • Site 1001

    Butte, Montana, 59701

  • Site 1002

    Dayton, Ohio, 45402

  • Site 1006

    Hazard, Kentucky, 41701

  • Site 1005

    Minneapolis, Minnesota, 55415

  • Site 1008

    Shreveport, Louisiana, 71103

  • Site 1004

    Splendora, Texas, 77372

Other trials in United States

Hungary7 sites

  • Site 4305

    Budapest, 1121

  • Site 4306

    Csorna, 9300

  • Site 4304

    Debrecen, 4043

  • Site 4302

    Farkasgyepű, 8582

  • Site 4307

    Miskolc, 3529

  • Site 4308

    Miskolc, 3529

  • Site 4303

    Törökbálint, 2045

Other trials in Hungary

Argentina6 sites

  • Site 3003

    Córdoba, X5000EPU

  • Site 3007

    Córdoba, X5000JRD

  • Site 3001

    Córdoba, X5004CDT

  • Site 3004

    Córdoba, X5016KEH

  • Site 3005

    La Plata, Buenos Aires, 1900

  • Site 3006

    Rosario, Santa Fe Province, S2000CVB

Other trials in Argentina

Russia6 sites

  • Site 4904

    Chelyabinsk, 454021

  • Site 4902

    Novosibirsk, 630102

  • Site 4903

    Saint Petersburg, 191163

  • Site 4901

    Saint Petersburg, 197706

  • Site 4906

    Smolensk, 214019

  • Site 4905

    Yaroslavl, 150062

Other trials in Russia

Georgia5 sites

  • Site 4206

    Tbilisi, 0101

  • Site 4204

    Tbilisi, 0144

  • Site 4205

    Tbilisi, 0144

  • Site 4201

    Tbilisi, 0159

  • Site 4202

    Tbilisi, 0186

Other trials in Georgia

Philippines5 sites

  • Site 2005

    Iloilo City, 5000

  • Site 2003

    Manila, 1000

  • Site 2004

    Manila, 1012

  • Site 2002

    Quezon City, 1100

  • Site 2001

    Quezon City, 1114

Other trials in Philippines

South Africa5 sites

  • Site 5103

    Benoni, Gauteng, 1500

  • Site 5102

    Krugersdorp, 1724

  • Site 5101

    Middelburg, Mpumalanga, 1050

  • Site 5104

    Pretoria, Gauteng, 181

  • Site 5105

    Thabazimbi, Limpopo, 380

Other trials in South Africa

Brazil4 sites

  • Site 3104

    Belo Horizonte, Minas Gerais, 30150-221

  • Site 3103

    Campinas, São Paulo, 13059-900

  • Site 3102

    Passo Fundo, Rio Grande Do Sol, 99010-080

  • Site 3101

    Sao Paulo Do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Peru4 sites

  • Site 3202

    Lima, Lima 18

  • Site 3204

    Lima, Lima 1

  • Site 3201

    Lima, Lima 29

  • Site 3205

    Trujillo, La Libertad

Other trials in Peru

Poland4 sites

  • Site 4701

    Lódz, 90-153

  • Site 4703

    Skierniewice, Lódzkie, 96-100

  • Site 4704

    Warsaw, Masovian Voivodeship, 02-097

  • Site 4702

    Wilkowice, 43-365

Other trials in Poland

Serbia4 sites

  • Site 5002

    Belgrade, 11000

  • Site 5004

    Kamenitz, 11080

  • Site 5001

    Kragujevac, Šumadijski Okrug, 34000

  • Site 5003

    Niš, Nišavski Okrug, 18204

Other trials in Serbia

Bosnia and Herzegovina3 sites

  • Site 4003

    Mostar, 88000

  • Site 4001

    Tuzla, 75000

  • Site 4004

    Zenica, 72000

Other trials in Bosnia and Herzegovina

Latvia3 sites

  • Site 4403

    Daugavpils, LV-5417

  • Site 4401

    Liepāja, LV-3414

  • Site 4402

    Riga, LV-1038

Other trials in Latvia

Netherlands2 sites

  • Site 4603

    Almelo, Overijssel, 7609 PP

  • Site 4602

    Helmond, 5707 HA

Other trials in Netherlands

Thailand1 site

  • Site 2103

    Nonthaburi, 10110

Other trials in Thailand

About this study

Official title: 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

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.

Read the detailed description

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. Lefamulin's in vitro antibacterial profile includes the most important bacterial pathogens causing respiratory tract infection (RTI). The antibacterial spectrum comprises S. pneumoniae, H. influenzae, M. catarrhalis, the atypical respiratory pathogens L. pneumophila, C. pneumoniae, and M. pneumoniae, S. aureus including MRSA and CA-MRSA, ß-haemolytic streptococci including S. pyogenes and S. agalactiae, and Enterococcus faecium including vancomycin-resistant enterococci (VRE). Moreover, as demonstrated in cross-resistance studies, lefamulin remains active against clinical isolates resistant to the following antimicrobial(s) (classes): macrolides, lincosamides, streptogramin B, oxazolidinones, tetracyclines, ß lactams, quinolones, trimethoprim-sulfametoxazole, mupirocin, and vancomycin.

Being tested
lefamulin, Moxifloxacin, Linezolid
Keywords
Pneumonia, CABP, CAP, Community acquired bacterial pneumonia
Medical subject headings
Community-Acquired Pneumonia, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lefamulinDrug

    Also called BC-3781

    antibacterial agent

  • MoxifloxacinDrug

    Also called Avelox

    antibacterial agent

  • LinezolidDrug

    Also called Zyvox

    antibacterial agent

Study groups in NCT02559310
Study groupRoleWhat they receive
LefamulinExperimentalIntravenous lefamulin with potential step-down to oral lefamulin
Receives: Drug: lefamulin
Moxifloxacin +/- LinezolidActive comparatorIntravenous moxifloxacin with potential step-down to oral moxifloxacin +/- linezolid
Receives: Drug: Moxifloxacin; Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early Clinical Response (ECR)

    ECR was defined as survival with improvement in at least 2 signs and symptoms of CABP (relative to baseline), no worsening of any CABP sign or symptom, and no use of concomitant antibiotics (other than adjunctive linezolid, as allowed by the study protocol) for the treatment of CABP through the ECR assessment.

    Measured: ECR was assessed 96 +/- 24 hours after the first dose of study drug.

Secondary outcomes (2)

  1. Investigator's Assessment of Clinical Response (IACR)

    IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP

    Measured: IACR was assessed at the Test-of-Cure visit; 5-10 days after the last dose of study drug.

  2. Investigator's Assessment of Clinical Response (IACR)

    IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP.

    Measured: IACR was assessed at the Test of Cure visit, 5 - 10 days after the last dose of study drug.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
551 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02559310
Sponsor's protocol ID
NAB-BC-3781-3101
Acronym
LEAP
Status last verified
Oct 2019
First submitted
22 Sep 2015
Last updated
23 Oct 2019
Data monitoring committee
Yes

Publications

  • File TM Jr, Alexander E, Goldberg L, Das AF, Sandrock C, Paukner S, Moran GJ. Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities. BMC Pulm Med. 2021 May 8;21(1):154. doi: 10.1186/s12890-021-01472-z.

    PubMed 33964925

  • File TM, Goldberg L, Das A, Sweeney C, Saviski J, Gelone SP, Seltzer E, Paukner S, Wicha WW, Talbot GH, Gasink LB. Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial. Clin Infect Dis. 2019 Nov 13;69(11):1856-1867. doi: 10.1093/cid/ciz090.

    PubMed 30722059

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lefamulin, Moxifloxacin and Linezolid in people with Community Acquired Pneumonia, run by Nabriva Therapeutics AG at 99 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in Bulgaria, Ukraine, Romania, United States, Hungary and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early Clinical Response (ECR) (time frame: ECR was assessed 96 +/- 24 hours after the first dose of study drug.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02559310, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.

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