Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia (LEAP2)
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| ClinicalTrials.gov Identifier: NCT02813694 |
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Recruitment Status :
Completed
First Posted : June 27, 2016
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
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Sponsor:
Nabriva Therapeutics AG
Information provided by (Responsible Party):
Nabriva Therapeutics AG
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Community Acquired Pneumonia |
| Interventions |
Drug: lefamulin Drug: Moxifloxacin |
| Enrollment | 738 |
Participant Flow
| Recruitment Details | The study was designed to enroll adults with CABP for which oral antibacterial therapy was appropriate. Subjects with PORT score of II, III and IV were eligible. The first subject was randomized in August 2016 and the last subject was randomized in December 2017 |
| Pre-assignment Details | Subjects who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group. Administration of study drug was expected to occur as soon as possible after the diagnosis of CABP with all Screening/baseline assessments expected to be completed within 24 hours before the first dose of study drug. |
| Arm/Group Title | Lefamulin | Moxifloxacin |
|---|---|---|
 Arm/Group Description |
oral lefamulin, 600mg | oral moxifloxacin, 400mg |
| Period Title: Overall Study | ||
| Started | 370 [1] | 368 [1] |
| Completed [2] | 353 | 354 [2] |
| Not Completed | 17 | 14 |
| Reason Not Completed | ||
| Physician Decision | 0 | 1 |
| Withdrawal by Subject | 10 | 9 |
| Lost to Follow-up | 1 | 1 |
| Death | 3 | 3 |
| Randomized- did not receive study drug | 2 | 0 |
| Patient hospitalized | 1 | 0 |
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[1]
Intent to Treat Analysis Set
[2]
Completed Study (Late Follow Up Assessment)
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Baseline Characteristics
| Arm/Group Title | Lefamulin | Moxifloxacin | Total | |
|---|---|---|---|---|
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Arm/Group Description |
oral lefamulin, 600mg | oral moxifloxacin, 400mg | Total of all reporting groups | |
| Overall Number of Baseline Participants | 370 | 368 | 738 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
| 57.4 (16.4) | 57.7 (16.2) | 57.5 (16.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
| Female |
163 44.1%
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188 51.1%
|
351 47.6%
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| Male |
207 55.9%
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180 48.9%
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387 52.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
| Hispanic or Latino |
45 12.2%
|
38 10.3%
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83 11.2%
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| Not Hispanic or Latino |
325 87.8%
|
330 89.7%
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655 88.8%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
|
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
| American Indian or Alaska Native |
24 6.5%
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17 4.6%
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41 5.6%
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| Asian |
49 13.2%
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53 14.4%
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102 13.8%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
19 5.1%
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22 6.0%
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41 5.6%
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| White |
274 74.1%
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270 73.4%
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544 73.7%
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| More than one race |
4 1.1%
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6 1.6%
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10 1.4%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 370 participants | 368 participants | 738 participants |
| Argentina | 6 | 7 | 13 | |
| Romania | 11 | 7 | 18 | |
| Hungary | 13 | 15 | 28 | |
| United States | 11 | 12 | 23 | |
| Philippines | 35 | 36 | 71 | |
| Ukraine | 65 | 63 | 128 | |
| Russia | 31 | 24 | 55 | |
| Spain | 0 | 1 | 1 | |
| South Korea | 12 | 14 | 26 | |
| Latvia | 3 | 0 | 3 | |
| Taiwan | 0 | 1 | 1 | |
| Poland | 4 | 3 | 7 | |
| Mexico | 1 | 3 | 4 | |
| South Africa | 21 | 34 | 55 | |
| Georgia | 22 | 19 | 41 | |
| Bulgaria | 38 | 42 | 80 | |
| Chile | 2 | 2 | 4 | |
| Serbia | 66 | 63 | 129 | |
| Peru | 29 | 22 | 51 | |
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Renal Status
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
| Severe impairment (CrCl <30 mL/min) |
4 1.1%
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3 0.8%
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7 0.9%
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| Moderate impairment (CrCl 30 to <60 mL/min) |
64 17.3%
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70 19.0%
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134 18.2%
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| Mild impairment (CrCl 60 to <90 mL/min) |
112 30.3%
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117 31.8%
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229 31.0%
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| Normal function (CrCl >/= 90 mL/min) |
190 51.4%
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178 48.4%
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368 49.9%
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Pneumonia Outcomes Research Team (PORT) Risk Class
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
| I |
1 0.3%
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2 0.5%
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3 0.4%
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| II |
183 49.5%
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189 51.4%
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372 50.4%
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| III |
145 39.2%
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133 36.1%
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278 37.7%
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| IV |
40 10.8%
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42 11.4%
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82 11.1%
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| V |
1 0.3%
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2 0.5%
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3 0.4%
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[1]
Measure Description: PORT Risk Class is a clinical prediction rule used to calculate risk of morbidity and mortality among patients presenting with community-acquired pneumonia taking into consideration age, history of comorbid conditions, physical examination findings, and laboratory or radiographic results. PORT Risk Class I is a PORT score of 0-50, II is 51-70, III is 71-90, IV is 91-130 and V is >130 with higher risk class indicating higher risk of morbidity and mortality.
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CURB-65 Score
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
| 0 |
87 23.5%
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80 21.7%
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167 22.6%
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| 1 |
197 53.2%
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196 53.3%
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393 53.3%
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| 2 |
74 20.0%
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77 20.9%
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151 20.5%
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| 3 |
12 3.2%
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13 3.5%
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25 3.4%
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| 4 |
0 0.0%
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2 0.5%
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2 0.3%
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| 5 |
0 0.0%
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0 0.0%
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0 0.0%
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[1]
Measure Description: CURB-65 is a clinical tool used to predict mortality in patients with community acquired pneumonia. The risk of death at 30 days increases as the score increases; a score of 0 indicates the lowest risk of death and a score of 5 indicates the highest risk of death. Defined as confusion of new onset, BUN >19 mg/dL, respiratory rate ≥30 breaths/min, systolic blood pressure <90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years.
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American Thoracic Society (ATS) Minor Severity Criteria
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
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31 8.4%
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37 10.1%
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68 9.2%
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[1]
Measure Description: ATS minor criteria are used to indicate severe community acquired pneumonia and suggests the need for intensive care unit (ICU) level care. Defined as presence of 3 or more of the following 9 criteria at baseline: respiratory rate of 30 breaths/min or greater, oxygen saturation less than 90% or PaO2 less than 60mmHg, blood urea nitrogen level of 20mg/dL or greater, white blood cell count less than 4,000/mm3, confusion, multilobar infiltrates, platelet level less than 100,000 cells/mm3, temperature lower than 36 °C, or systolic blood pressure less than 90mmHg.
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Systemic inflammatory response syndrome (SIRS) Criteria
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
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353 95.4%
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342 92.9%
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695 94.2%
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[1]
Measure Description: SIRS is used to define a clinical response to a nonspecific insult of either infectious or noninfectious origin. SIRS is defined as a subject meeting at least 2 or more of the following: Fever of more than 38C (100.4F) or less than 36C (96.8F); heart rate greater than 90 beats/min; respiratory rate greater than 20 breaths/min or PaCO2 less than 32 mm Hg; abnormal white blood cell count (greater than 12,000/microL or less than 4,000/microL or greater than 10% immature band forms)
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Bacteremic
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
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6 1.6%
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9 2.4%
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15 2.0%
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Received Single Dose Short-Acting Antibacterial within 72 hrs of Randomization
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 370 participants | 368 participants | 738 participants | |
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77 20.8%
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72 19.6%
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149 20.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
All data from the study is confidential information. Sponsor has the right to publish first. Thereafter, PI may publish data from the study, but PI must submit the publication to Sponsor for review at least 60 days prior to publication. Sponsor may remove any confidential and/or proprietary information. If Sponsor's publication is not submitted within 12 months after the study, or if Sponsor decides not to publish, PI may publish the data, subject to Sponsor's rights in the agreement.
Results Point of Contact
| Name/Title: | Jennifer Schranz, M.D., Chief Medical Officer |
| Organization: | Nabriva Therapeutics US, Inc |
| Phone: | 610 981 2842 |
| EMail: | jennifer.schranz@nabriva.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nabriva Therapeutics AG |
| ClinicalTrials.gov Identifier: | NCT02813694 |
| Other Study ID Numbers: |
NAB-BC-3781-3102 |
| First Submitted: | June 20, 2016 |
| First Posted: | June 27, 2016 |
| Results First Submitted: | August 28, 2019 |
| Results First Posted: | October 23, 2019 |
| Last Update Posted: | October 23, 2019 |