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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02813694
Other study ID # NAB-BC-3781-3102
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2016
Est. completion date January 2018

Study information

Verified date September 2019
Source Nabriva Therapeutics AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 738
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Each subject must:

1. Be male or female at least 18 years of age.

2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.

3. 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.

- Purulent sputum production.

- Chest pain due to pneumonia.

4. 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).

5. 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.

6. 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).

7. 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.

Exclusion Criteria:

Each subject must NOT:

1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization.

2. Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens.

3. 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.

4. 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).

5. 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).

6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
lefamulin
antibacterial agent
Moxifloxacin
antibacterial agent

Locations

Country Name City State
Argentina Site 3059 Buenos Aires AV
Argentina Site 3056 Ciudad Autónoma de Buenos Aires
Argentina Site 3052 Cordoba
Argentina Site 3054 Cordoba
Argentina Site 3057 Cordoba
Argentina Site 3058 General Pacheco
Argentina Site 3051 La Plata
Argentina Site 3053 La Plata
Brazil Site 3154 Belo Horizonte
Brazil Site 3153 Passo Fundo
Brazil Site 3152 Sao Jose do Rio Preto
Bulgaria 4162 Ruse
Bulgaria Site 4154 Sliven
Bulgaria 4163 Sofia
Bulgaria 4164 Sofia
Bulgaria 4165 Sofia
Bulgaria Site 4153 Sofia
Bulgaria Site 4156 Sofia
Bulgaria Site 4157 Sofia
Bulgaria Site 4160 Sofia
Bulgaria Site 4161 Sofia
Bulgaria Site 4158 Stara Zagora
Bulgaria Site 4159 Vidin
Bulgaria Site 4152 Vratsa
Chile Site 3353 Santiago
Chile Site 3356 Santiago
Chile Site 3357 Santiago
Chile Site 3354 Talca
Chile Site 3352 Temuco
Chile Site 3355 Valdivia
Georgia Site 4256 Batumi
Georgia Site 4252 Tbilisi
Georgia Site 4253 Tbilisi
Georgia Site 4254 Tbilisi
Georgia Site 4255 Tbilisi
Hungary Site 4353 Budapest
Hungary Site 4354 Budapest
Hungary Site 4352 Matrahaza
Hungary Site 4351 Torokbalint
Korea, Republic of Site 2257 Bucheon-si
Korea, Republic of Site 2253 Daegu
Korea, Republic of Site 2251 Seoul
Korea, Republic of Site 2252 Seoul
Korea, Republic of Site 2255 Seoul
Korea, Republic of Site 2256 Seoul
Korea, Republic of Site 2254 Uijeongbu Si Gyeonggi-do
Latvia Site 4451 Liepaja
Latvia Site 4453 Riga
Latvia Site 4452 Valmiera
Mexico Site 1153 Aguascalientes
Mexico Site 1154 Guadalajara
Mexico Site 1151 Monterrey
Mexico Site 1152 Toluca
Peru Site 3262 Arequipa
Peru Site 3263 Cusco
Peru Site 3261 Cuzco
Peru Site 3264 Grau Lima
Peru Site 3254 Ica
Peru Site 3259 Iquitos
Peru Site 3251 La Libertad
Peru Site 3252 Lima
Peru Site 3253 Lima
Peru Site 3255 Lima
Peru Site 3257 Lima
Peru Site 3260 Lima
Peru Site 3265 Lima
Peru Site 3258 Lima Lima
Peru Site 3256 Piura
Philippines Site 2053 Caloocan City
Philippines Site 2055 Cebu
Philippines Site 2052 Iloilo City
Philippines Site 2054 Quezon
Philippines Site 2051 Quezon City
Philippines Site 2056 Quezon City
Poland Site 4755 Bochnia
Poland Site 4754 Chodziez
Poland Site 4753 Krakow
Poland Site 4756 Kraków
Poland Site 4757 Siedlce
Romania Site 4854 Bucuresti
Romania Site 4855 Bucuresti
Romania Site 4858 Bucuresti
Romania Site 4853 Cluj-Napoca
Romania Site 4851 Codlea
Romania Site 4857 Craiova
Romania Site 4856 Timisoara
Russian Federation Site 4953 Barnaul
Russian Federation Site 4952 Moscow
Russian Federation Site 4957 Moscow
Russian Federation Site 4954 Novosibirsk
Russian Federation Site 4959 Saratov
Russian Federation Site 4958 Smolensk
Russian Federation Site 4951 St. Petersburg
Russian Federation Site 4955 St. Petersburg
Serbia 5057 Belgrade
Serbia Site 5051 Belgrade
Serbia Site 5052 Belgrade
Serbia Site 5056 Belgrade
Serbia Site 5055 Knez Selo
Serbia Site 5054 Kragujevac
Serbia Site 5053 Sremska Kamenica
South Africa Site 5151 Bloemfontein
South Africa Site 5154 Krugersdorp
South Africa Site 5155 Middelburg
South Africa Site 5156 Pretoria
South Africa Site 5152 Queenswood
South Africa Site 5153 Witbank
Spain Site 4554 Alicante
Spain Site 4556 Badalona
Spain Site 4552 Barcelona
Spain Site 4555 Barcelona
Spain Site 4551 Madrid
Spain Site 4553 Madrid
Taiwan Site 2351 Kaohsiung
Taiwan Site 2352 Kaohsiung
Taiwan Site 2354 Taipei
Ukraine Site 5264 Chernivtsi
Ukraine Site 5258 Ivano-Frankivs'k
Ukraine Site 5261 Ivano-Frankivs'k
Ukraine Site 5254 Kharkiv
Ukraine Site 5256 Kharkiv
Ukraine Site 5255 Kherson
Ukraine Site 5251 Kyiv
Ukraine SIte 5252 Kyiv
Ukraine Site 5263 Kyiv
Ukraine Site 5265 Kyiv
Ukraine Site 5259 Poltava
Ukraine Site 5260 Vinnytsya
Ukraine Site 5253 Zaporizhzhya
Ukraine Site 5257 Zaporizhzhya
United States 1080 Beverly Hills California
United States Site 1054 Butte Montana
United States Site 1059 Charlottesville Virginia
United States Site 1064 DeBary Florida
United States Site 1052 DeLand Florida
United States Site 1055 Detroit Michigan
United States Site 1062 Detroit Michigan
United States Site 1065 Fresno California
United States 1077 Hendersonville Tennessee
United States Site 1060 Houston Texas
United States Site 1069 Houston Texas
United States Site 1067 Lima Ohio
United States 1076 Miami Florida
United States Site 1051 Michigan City Indiana
United States Site 1057 Natchitoches Louisiana
United States Site 1073 New Bedford Massachusetts
United States 1078 Northridge California
United States Site 1072 Oxnard California
United States Site 1056 Rapid City South Dakota
United States Site 1068 Royal Oak Michigan
United States Site 1070 Sacramento California
United States Site 1058 Saint Louis Missouri
United States 1079 Sherman Oaks California
United States Site 1066 Splendora Texas
United States Site 1053 Sylmar California

Sponsors (1)

Lead Sponsor Collaborator
Nabriva Therapeutics AG

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Chile,  Georgia,  Hungary,  Korea, Republic of,  Latvia,  Mexico,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Taiwan,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 96 hours +/- 24 hours after first dose of study drug
Secondary 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 IACR was assessed at the Test-of-Cure Visit; 5 to 10 days after last dose of study drug
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