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Community Acquired PneumoniaPhase 3LEAP2NCT02813694

Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia

A Phase 3 study testing lefamulin and Moxifloxacin in people with Community Acquired Pneumonia, run by Nabriva Therapeutics AG at 155 sites in 20 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 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 and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
738 participants
Where
155 sitesin 20 countries
Study dates
Aug 2016to Jan 2018
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

  • Each subject must:
  • 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 (less than or equal to 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.
Show all 19Show fewer
  • Purulent sputum production.
  • 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 < 4 500 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 of II, III, or IV and be an appropriate candidate for oral antibiotic therapy as treatment for the current episode of CABP.

Who cannot join

  • Each subject must NOT:
  • 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., MRSA, 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).

Trial locations and contacts

155 sites in 20 countries.

155 sites in 20 countries

United States25 sites

  • 1080

    Beverly Hills, California

  • Site 1054

    Butte, Montana, 59701

  • Site 1059

    Charlottesville, Virginia, 22908

  • Site 1064

    DeBary, Florida, 32713

  • Site 1052

    DeLand, Florida, 32720

  • Site 1055

    Detroit, Michigan, 48201

  • Site 1062

    Detroit, Michigan, 48235

  • Site 1065

    Fresno, California, 93701

  • 1077

    Hendersonville, Tennessee

  • Site 1060

    Houston, Texas, 77070

  • Site 1069

    Houston, Texas, 77093

  • Site 1067

    Lima, Ohio, 45801

  • 1076

    Miami, Florida

  • Site 1051

    Michigan City, Indiana, 46360

  • Site 1057

    Natchitoches, Louisiana, 71457

  • Site 1073

    New Bedford, Massachusetts, 02740

  • 1078

    Northridge, California

  • Site 1072

    Oxnard, California, 93030

  • Site 1056

    Rapid City, South Dakota, 57702

  • Site 1068

    Royal Oak, Michigan, 48073

  • Site 1070

    Sacramento, California, 95817

  • 1079

    Sherman Oaks, California

  • Site 1066

    Splendora, Texas, 77372

  • Site 1058

    St Louis, Missouri, 63110

  • Site 1053

    Sylmar, California, 91342

Other trials in United States

Peru15 sites

  • Site 3262

    Arequipa

  • Site 3263

    Cusco

  • Site 3261

    Cuzco

  • Site 3264

    Grau, Lima region

  • Site 3254

    Ica

  • Site 3259

    Iquitos

  • Site 3251

    La Libertad

  • Site 3252

    Lima

  • Site 3253

    Lima

  • Site 3255

    Lima

  • Site 3257

    Lima

  • Site 3260

    Lima

  • Site 3265

    Lima

  • Site 3258

    Lima Lima

  • Site 3256

    Piura

Other trials in Peru

Ukraine14 sites

  • Site 5264

    Chernivtsi, 58001

  • Site 5261

    Ivano-Frankivsk, 76018

  • Site 5258

    Ivano-Frankivsk, 7601

  • Site 5256

    Kharkiv, 61124

  • Site 5254

    Kharkiv, 61157

  • Site 5255

    Kherson, 73000

  • Site 5263

    Kyiv, 1133

  • SIte 5252

    Kyiv, 2091

  • Site 5251

    Kyiv, 3680

  • Site 5265

    Kyiv, 3680

  • Site 5259

    Poltava, 3603

  • Site 5260

    Vinnytsia, 21029

  • Site 5253

    Zaporizhzhya, 69035

  • Site 5257

    Zaporizhzhya, 69065

Other trials in Ukraine

Bulgaria13 sites

  • 4162

    Rousse, 7002

  • Site 4154

    Sliven, 8800

  • Site 4160

    Sofia, 1233

  • Site 4157

    Sofia, 1336

  • Site 4153

    Sofia, 1606

  • Site 4156

    Sofia, 1606

  • Site 4161

    Sofia, 1680

  • 4163

    Sofia

  • 4164

    Sofia

  • 4165

    Sofia

  • Site 4158

    Stara Zagora, 6000

  • Site 4159

    Vidin, 3700

  • Site 4152

    Vratsa, 3000

Other trials in Bulgaria

Argentina8 sites

  • Site 3056

    Buenos Aires

  • Site 3059

    Buenos Aires AV

  • Site 3054

    Córdoba, X5000EPU

  • Site 3052

    Córdoba

  • Site 3057

    Córdoba

  • Site 3058

    General Pacheco

  • Site 3051

    La Plata

  • Site 3053

    La Plata

Other trials in Argentina

Russia8 sites

  • Site 4953

    Barnaul, 656045

  • Site 4957

    Moscow, 117913

  • Site 4952

    Moscow, 119192

  • Site 4954

    Novosibirsk, 6300

  • Site 4955

    Saint Petersburg, 1962

  • Site 4951

    Saint Petersburg, 198205

  • Site 4959

    Saratov, 410053

  • Site 4958

    Smolensk, 214019

Other trials in Russia

Romania7 sites

  • Site 4855

    Bucharest, 21105

  • Site 4858

    Bucharest, 21659

  • Site 4854

    Bucharest, 30303

  • Site 4853

    Cluj-Napoca, 400371

  • Site 4851

    Codlea, 505100

  • Site 4857

    Craiova, 200515

  • Site 4856

    Timișoara, 300310

Other trials in Romania

Serbia7 sites

  • Site 5052

    Belgrade, 11000

  • Site 5056

    Belgrade, 11000

  • Site 5051

    Belgrade, 11080

  • 5057

    Belgrade

  • Site 5053

    Kamenitz, 21204

  • Site 5055

    Knez-Selo, 1820

  • Site 5054

    Kragujevac, 34000

Other trials in Serbia

South Korea7 sites

  • Site 2257

    Bucheon-si, 14647

  • Site 2253

    Daegu, 42415

  • Site 2255

    Seoul, 143-914

  • Site 2256

    Seoul, 152-703

  • Site 2251

    Seoul, 2259

  • Site 2252

    Seoul, 7985

  • Site 2254

    Uijeongbu-si, Gyeonggi-do, 11765

Other trials in South Korea

Chile6 sites

  • Site 3353

    Santiago

  • Site 3356

    Santiago

  • Site 3357

    Santiago

  • Site 3354

    Talca

  • Site 3352

    Temuco

  • Site 3355

    Valdivia

Other trials in Chile

Philippines6 sites

  • Site 2053

    Caloocan, 1400

  • Site 2055

    Cebu, 6000

  • Site 2052

    Iloilo City, 5000

  • Site 2054

    Quezon, 1109

  • Site 2056

    Quezon City, 1100

  • Site 2051

    Quezon City

Other trials in Philippines

South Africa6 sites

  • Site 5151

    Bloemfontein, 9301

  • Site 5154

    Krugersdorp, 1739

  • Site 5155

    Middelburg, 1050

  • Site 5156

    Pretoria

  • Site 5152

    Queenswood, 186

  • Site 5153

    Witbank, 1035

Other trials in South Africa

Spain6 sites

  • Site 4554

    Alicante, 3203

  • Site 4556

    Badalona, 8916

  • Site 4552

    Barcelona, 8003

  • Site 4555

    Barcelona, 8035

  • Site 4553

    Madrid, 28040

  • Site 4551

    Madrid, 28046

Other trials in Spain

Georgia5 sites

  • Site 4256

    Batumi

  • Site 4253

    Tbilisi, 101

  • Site 4255

    Tbilisi, 159

  • Site 4252

    Tbilisi, 179

  • Site 4254

    Tbilisi, 186

Other trials in Georgia

Poland5 sites

  • Site 4755

    Bochnia, 32-700

  • Site 4754

    Chodzież, 64-800

  • Site 4753

    Krakow, 31-011

  • Site 4756

    Krakow, 31-202

  • Site 4757

    Siedlce, 08-110

Other trials in Poland

Hungary4 sites

  • Site 4354

    Budapest, 1122

  • Site 4353

    Budapest, 1134

  • Site 4352

    Mátraháza, 3233

  • Site 4351

    Törökbálint, 2045

Other trials in Hungary

Mexico4 sites

  • Site 1153

    Aguascalientes, 20230

  • Site 1154

    Guadalajara, 44280

  • Site 1151

    Monterrey, 64460

  • Site 1152

    Toluca, 52140

Other trials in Mexico

Brazil3 sites

  • Site 3154

    Belo Horizonte, 30150-221

  • Site 3153

    Passo Fundo, 99010-080

  • Site 3152

    São José do Rio Preto, 15090-000

Other trials in Brazil

Latvia3 sites

  • Site 4451

    Liepāja, LV3414

  • Site 4453

    Riga, LV-1002

  • Site 4452

    Valmiera, LV 4201

Other trials in Latvia

Taiwan3 sites

  • Site 2352

    Kaohsiung City, 82445

  • Site 2351

    Kaohsiung City

  • Site 2354

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC 3781) Versus Oral Moxifloxacin 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 community-acquired bacterial pneumonia

Read the detailed description

Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class known as the pleuromutilins. The oral dosage form of lefamulin is 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
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

Study groups in NCT02813694
Study groupRoleWhat they receive
lefamulinExperimentaloral lefamulin, 600mg
Receives: Drug: lefamulin
MoxifloxacinActive comparatororal moxifloxacin, 400mg
Receives: Drug: Moxifloxacin

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 for the treatment of CABP through the ECR assessment

    Measured: 96 hours +/- 24 hours after first dose of study drug

Secondary outcomes (1)

  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 to 10 days after 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 posted27 Jun 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJan 2018
  4. Study completionJan 2018

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
738 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02813694
Sponsor's protocol ID
NAB-BC-3781-3102
Acronym
LEAP2
Status last verified
Sep 2019
First submitted
20 Jun 2016
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

  • Alexander E, Goldberg L, Das AF, Moran GJ, Sandrock C, Gasink LB, Spera P, Sweeney C, Paukner S, Wicha WW, Gelone SP, Schranz J. Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial. JAMA. 2019 Nov 5;322(17):1661-1671. doi: 10.1001/jama.2019.15468.

    PubMed 31560372

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lefamulin and Moxifloxacin in people with Community Acquired Pneumonia, run by Nabriva Therapeutics AG at 155 sites in 20 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 19 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 155 sites in United States, Peru, Ukraine, Bulgaria, Argentina and 15 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: 96 hours +/- 24 hours after 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 NCT02813694, 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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