Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

Condition(s) targeted: Pneumonia, Bacterial

Intervention: Amikacin Inhalation Solution (BAY41-6551) (Drug); Aerosolized Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

To evaluate the efficacy and safety of adjunctive aerosolized BAY 41-6551 (amikacin inhalation solution) versus aerosolized placebo in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics

Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of cured patients in the BAY41-6551 group divided by the proportion of cured patients in the placebo group

Secondary outcome:

Number of days on mechanical ventilation through the Day 28 visit

Number of intensive care unit (ICU) days at the Day 28 visit

Number of days in the hospital

Relapse rates

Per patient microbiological response rates at the Test Of Cure (TOC) visit

Microbiological recurrence rates at the TOC and Day 28 Visit

Emergence of new potential respiratory pathogens during the treatment period.

Emergence of resistance among baseline pathogens in those patients with persistent infection or colonization

Number of patients who have received at least one dose of study drug and reported an adverse event

Mortality during the treatment period, Day 15, and Day 28 visit

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and non-pregnant, non-lactating females, 18 years of age or older

- Intubated and mechanically-ventilated

- Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on

chest radiograph

- Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory

secretions, or suspected Gram-negative pathogen

- Impaired oxygenation

- Clinical Pulmonary Infection Score (CPIS) of at least 6

- Presence of or at least two risk factors for multi-drug resistant organisms

Exclusion Criteria:

- - History of hypersensitivity to amikacin or other aminoglycosides

- Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours

at the time of randomization

- Known or suspected bacteremia secondary to Staphylococcus aureus

- A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test

- Patients with a serum creatinine > 2 mg/dL (177 µmol/L) [Exception: Patients with a

serum creatinine > 2 mg/dL (177 umol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment]

- Has been on mechanical ventilation for > 28 days

- Is participating in or has participated in other investigational interventional

studies within the last 28 days prior to study treatment

- The risk of rapidly fatal illness and death within 72 hrs, or any concomitant

condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy

- Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10

- Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V

ECMO)

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Antwerpen 2060, Belgium; Recruiting

Bruxelles - Brussel 1070, Belgium; Not yet recruiting

Bruxelles - Brussel 1090, Belgium; Recruiting

Bruxelles - Brussel 1200, Belgium; Recruiting

Gent 9000, Belgium; Not yet recruiting

Yvoir 5530, Belgium; Recruiting

Plovdiv 4002, Bulgaria; Not yet recruiting

Rousse 7000, Bulgaria; Not yet recruiting

Sofia 1606, Bulgaria; Not yet recruiting

Sofia 1527, Bulgaria; Not yet recruiting

Sofia 1709, Bulgaria; Not yet recruiting

Stara Zagora 6000, Bulgaria; Not yet recruiting

Veliko Turnovo 5000, Bulgaria; Not yet recruiting

Beiing, China; Not yet recruiting

Beijing, China; Not yet recruiting

Beijing 100020, China; Not yet recruiting

Beijing 100020, China; Terminated

Beijing 100029, China; Recruiting

Beijing 100029, China; Not yet recruiting

Beijing 100038, China; Not yet recruiting

Beijing 100044, China; Not yet recruiting

Beijing 100083, China; Not yet recruiting

Beijing 100088, China; Recruiting

Beijing 100853, China; Recruiting

Beijing 100020, China; Recruiting

Changsha, China; Recruiting

Chongqing 400010, China; Recruiting

Chongqing 400016, China; Not yet recruiting

Chongqing 400038, China; Not yet recruiting

Chongqing 400042, China; Terminated

Fuzhou 350025, China; Recruiting

Qingdao 266071, China; Not yet recruiting

Shanghai 200003, China; Not yet recruiting

Shanghai 200032, China; Not yet recruiting

Shanghai 200040, China; Recruiting

Shanghai 200080, China; Terminated

Shanghai, China; Not yet recruiting

Tianjin 300052, China; Not yet recruiting

Brno 62500, Czech Republic; Not yet recruiting

Hradec Kralove 50005, Czech Republic; Not yet recruiting

Praha 150 06, Czech Republic; Not yet recruiting

Angers Cedex 49100, France; Terminated

Argenteuil Cedex 95107, France; Terminated

Colombes 92701, France; Terminated

Creteil 94010, France; Not yet recruiting

Limoges 87042, France; Terminated

Lyon 69003, France; Recruiting

Lyon 69003, France; Terminated

Nice 06002, France; Recruiting

Nimes 30029, France; Recruiting

Paris Cedex 04 75181, France; Terminated

Paris 75877, France; Recruiting

Paris 75651, France; Recruiting

Paris 75674, France; Recruiting

Paris 75014, France; Recruiting

Poitiers 86021, France; Recruiting

Saint Michel 16470, France; Terminated

Toulouse 31059, France; Terminated

Vesoul 70014, France; Terminated

Villefranche Sur Saône Cedex 69655, France; Terminated

Berlin 10117, Germany; Terminated

Berlin 13353, Germany; Terminated

Alexandroupolis 68100, Greece; Not yet recruiting

Heraklion 711 10, Greece; Recruiting

Larissa 41221, Greece; Recruiting

Mezourlo / Larissa, Greece; Recruiting

Budapest 1115, Hungary; Terminated

Budapest 1121, Hungary; Recruiting

Budapest 1134, Hungary; Not yet recruiting

Budapest 1145, Hungary; Terminated

Budapest H-1125, Hungary; Recruiting

Budapest H-1204, Hungary; Terminated

Kistarcsa 2143, Hungary; Recruiting

Miskolc 3501, Hungary; Terminated

Szeged 6720, Hungary; Terminated

Szekesfehervar 8000, Hungary; Not yet recruiting

Vac 2600, Hungary; Terminated

Vac 2600, Hungary; Recruiting

Afula 1834111, Israel; Not yet recruiting

Haifa 3109601, Israel; Not yet recruiting

Holon 5810001, Israel; Not yet recruiting

Petach Tikva 4941492, Israel; Recruiting

Tel Aviv 64239, Israel; Recruiting

Tel Hashomer 5262000, Israel; Recruiting

Bergamo 24127, Italy; Not yet recruiting

Milano 20162, Italy; Not yet recruiting

Novara 28100, Italy; Not yet recruiting

Padova 35128, Italy; Not yet recruiting

Pavia 27100, Italy; Not yet recruiting

Fukuoka 811-0213, Japan; Not yet recruiting

Kumamoto 860-0008, Japan; Recruiting

Kumamoto 860-8556, Japan; Not yet recruiting

Kyoto 607-8062, Japan; Not yet recruiting

Nagasaki 852-8501, Japan; Recruiting

Niigata 950-1197, Japan; Not yet recruiting

Niigata 951-8520, Japan; Not yet recruiting

Okayama 700-8505, Japan; Not yet recruiting

Osaka 540-0006, Japan; Recruiting

Osaka 543-0035, Japan; Not yet recruiting

Osaka 558-8558, Japan; Terminated

Amsterdam 1081 HV, Netherlands; Terminated

Amsterdam 1105 AZ, Netherlands; Terminated

Enschede 7511 JX, Netherlands; Not yet recruiting

Nijmegen 6525 GA, Netherlands; Recruiting

Rotterdam 3083 AN, Netherlands; Not yet recruiting

Utrecht 3584 CX, Netherlands; Terminated

Bydgoszcz 85-094, Poland; Terminated

Krakow 31-503, Poland; Terminated

Krakow 31-826, Poland; Terminated

Lodz 90-549, Poland; Terminated

Poznan 60-355, Poland; Terminated

Poznan 60-479, Poland; Terminated

Szczecin 70-111, Poland; Recruiting

Szczecin 71-252, Poland; Terminated

Warszawa 02-005, Poland; Terminated

Braga 4710-243, Portugal; Not yet recruiting

Porto 4099, Portugal; Not yet recruiting

Porto 4200-072, Portugal; Recruiting

Porto 4200-319, Portugal; Not yet recruiting

Bucharest 050098, Romania; Not yet recruiting

Cluj-Napoca 400006, Romania; Not yet recruiting

Moscow 117049, Russian Federation; Terminated

Moscow 123060, Russian Federation; Terminated

Novosibirsk 630008, Russian Federation; Terminated

Novosibirsk 630051, Russian Federation; Terminated

Smolensk 214018, Russian Federation; Recruiting

St. Petersburg 196247, Russian Federation; Terminated

Yaroslavl 150003, Russian Federation; Recruiting

Singapore 529889, Singapore; Not yet recruiting

Singapore, Singapore; Not yet recruiting

Alicante 03010, Spain; Terminated

Barcelona 08035, Spain; Terminated

Barcelona 08035, Spain; Not yet recruiting

Barcelona 08036, Spain; Recruiting

Girona 17007, Spain; Recruiting

Madrid 28034, Spain; Recruiting

Madrid 28040, Spain; Not yet recruiting

Valencia 46026, Spain; Recruiting

Bern 3010, Switzerland; Not yet recruiting

Genève 1211, Switzerland; Not yet recruiting

Kharkiv 61018, Ukraine; Not yet recruiting

Kiev 03110, Ukraine; Not yet recruiting

Kyiv 01133, Ukraine; Not yet recruiting

Lugansk 91045, Ukraine; Not yet recruiting

Poltava 36011, Ukraine; Not yet recruiting

Vinnitsa 21000, Ukraine; Not yet recruiting

Glasgow G42 9TY, United Kingdom; Not yet recruiting

Leeds LS9 7TF, United Kingdom; Not yet recruiting

London SE1 7EH, United Kingdom; Not yet recruiting

Winchester SO22 5DG, United Kingdom; Not yet recruiting

Nagakute, Aichi 480-1195, Japan; Not yet recruiting

Nagoya, Aichi 454-8502, Japan; Terminated

Nagoya, Aichi 460-0001, Japan; Not yet recruiting

Seto, Aichi 489-8642, Japan; Recruiting

Haidari, Attica 12462, Greece; Recruiting

Mannheim, Baden-Württemberg 68167, Germany; Terminated

Tübingen, Baden-Württemberg 72076, Germany; Terminated

Tübingen, Baden-Württemberg 72076, Germany; Not yet recruiting

Badalona, Barcelona 08916, Spain; Terminated

L'Hospitalet de Llobregat, Barcelona 08907, Spain; Recruiting

Terrassa, Barcelona 08221, Spain; Recruiting

München, Bayern 81545, Germany; Terminated

Regensburg, Bayern 93053, Germany; Terminated

Barcelona, Catalunya 08003, Spain; Terminated

Fuzhou, Fujian, China; Not yet recruiting

Onga, Fukuoka 807-0051, Japan; Not yet recruiting

Guangzhou, Guangdong 510120, China; Recruiting

Guangzhou, Guangdong 510515, China; Terminated

Guangzhou, Guangdong, China; Terminated

Shenzhen, Guangdong, China; Recruiting

Nanning, Guangxi 530021, China; Not yet recruiting

Maebashi, Gunma 371-8511, Japan; Recruiting

Haikou, Hainan 570311, China; Recruiting

Haikou, Hainan, China; Recruiting

Southampton, Hampshire SO16 6YD, United Kingdom; Not yet recruiting

Frankfurt, Hessen 60590, Germany; Terminated

Wuhan, Hubei 430030, China; Not yet recruiting

Wuhan, Hubei 430060, China; Terminated

Changsha, Hunan 410008, China; Recruiting

Changsha, Hunan 410011, China; Terminated

Changsha, Hunan 410013, China; Not yet recruiting

Himeji, Hyogo 670-8520, Japan; Recruiting

Nakagun, Ibaraki 319-1113, Japan; Recruiting

Baotou, Inner Mongolia 014010, China; Not yet recruiting

Morioka, Iwate 020-8505, Japan; Not yet recruiting

Nanjing, Jiangsu 210029, China; Recruiting

Suzhou, Jiangsu 215006, China; Not yet recruiting

Changchun, Jilin, China; Recruiting

Changchun, Jilin, China; Not yet recruiting

Sagamihara, Kanagawa 252-0375, Japan; Terminated

Yokohama, Kanagawa 230-8765, Japan; Terminated

Shenyang, Liaoning 110004, China; Recruiting

Shenyang, Liaoning 11000, China; Not yet recruiting

Getafe, Madrid 28905, Spain; Recruiting

Rostock, Mecklenburg-Vorpommern 181057, Germany; Terminated

Matsusaka, Mie 515-8544, Japan; Recruiting

Matsumoto, Nagano 399-0021, Japan; Terminated

Omura, Nagasaki 856-8562, Japan; Recruiting

Sasebo, Nagasaki 857-8511, Japan; Not yet recruiting

Hannover, Niedersachsen 30625, Germany; Not yet recruiting

Yinchuan, Ningxia, China; Not yet recruiting

Aachen, Nordrhein-Westfalen 52074, Germany; Not yet recruiting

Köln, Nordrhein-Westfalen 50937, Germany; Not yet recruiting

Shimajiri-gun, Okinawa 901-1193, Japan; Not yet recruiting

Izumisano, Osaka 598-8577, Japan; Recruiting

Sakai, Osaka 591-8555, Japan; Terminated

Dresden, Sachsen 01307, Germany; Not yet recruiting

Leipzig, Sachsen 04289, Germany; Terminated

Halle, Sachsen-Anhalt 06112, Germany; Terminated

Xi'an, Shaanxi 710061, China; Recruiting

Xi'an, Shaanxi 710032, China; Recruiting

Jinan, Shandong, China; Not yet recruiting

Qingdao, Shandong 266100, China; Not yet recruiting

Chengdu, Sichuan, China; Terminated

Chengdu, Sichuan 610041, China; Recruiting

Bunkyo-ku, Tokyo 113-8519, Japan; Not yet recruiting

Bunkyo-ku, Tokyo 113-8655, Japan; Terminated

Itabashi-ku, Tokyo 173-8606, Japan; Terminated

Ota-ku, Tokyo 143-8541, Japan; Terminated

Urumchi, Xinjiang, China; Not yet recruiting

Hofu, Yamaguchi 747-8511, Japan; Terminated

Hangzhou, Zhejiang 310016, China; Recruiting

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: May 2013
Last updated: August 3, 2015