Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia

Condition(s) targeted: Bacterial Pneumonia

Intervention: ceftaroline (Drug); ceftriaxone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cerexa, Inc.

Official(s) and/or principal investigator(s):
Thomas M File, MD, MS, Study Director, Affiliation: Summa Health System

Overall contact:
Trial Coordinator, Email: clinicaltrials@cerexa.com

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Determine the non-inferiority of ceftaroline compared to that for ceftriaxone in adult subjects with community-acquired pneumonia (CAP)

Secondary outcome:

Evaluate the clinical response

Evaluate the microbiological success rate

Evaluate the clinical and microbiological response by pathogen

Evaluate clinical relapse

Evaluate microbiological re-infection/recurrence

Evaluate safety

Detailed description: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

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

Criteria:

Inclusion Criteria:

Subjects are required to meet the following inclusion criteria:

- Community-acquired pneumonia

- initial hospitalization, or treatment in an emergency room or urgent care setting

- infection would require initial treatment with IV antimicrobials.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

- CAP suitable for outpatient therapy with an oral antimicrobial agent

- respiratory tract infections not due to community-acquired bacterial

- Non-infectious causes of pulmonary infiltrates

- Pleural empyema

- Infection with an atypical organism

- History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial

- History of any hypersensitivity or allergic reaction to clarithromycin or any

macrolide/ ketolide

Trial Coordinator, Email: clinicaltrials@cerexa.com

Investigational Site, Buenos Aires B6700AQJ, Argentina; Recruiting

Investigational Site, Vicente Lopez 1602, Argentina; Recruiting

Investigational Site, Buenos Aires C1155ADP, Argentina; Recruiting

Investigational Site, Buenos Aires B1702FWM, Argentina; Recruiting

Investigational Site, Buenos Aires 1650, Argentina; Recruiting

Investigational Site, Buenos Aires C1430BKC, Argentina; Recruiting

Investigational Site, Buenos Aires C1437 BZK, Argentina; Recruiting

Investigational Site, Buenos Aires 1748, Argentina; Recruiting

Investigational Site, Wien A-1030, Austria; Recruiting

Investigational Site, Vienna A-1090, Austria; Recruiting

Investigational site, Wien A-1030, Austria; Recruiting

Investigational Site, Curitiba-PR 80810-040, Brazil; Recruiting

Investigational Site 1, Belo Horizonte MG 30150-221, Brazil; Recruiting

Investigational Site, Juiz de Fora 36036-110, Brazil; Recruiting

Investigational Site 2, Belo Horizonte 30140-062, Brazil; Recruiting

Investigational Site, Campinas SP 13059-900, Brazil; Recruiting

Investigational site, Porto Alegre 90035-001, Brazil; Recruiting

Investigational Site, Sao Paolo 04038-905, Brazil; Recruiting

Investigational Site, Sao Paolo 17201-340, Brazil; Recruiting

Investigational Site, Sofia 1431, Bulgaria; Recruiting

Investigational Site, Varna 9010, Bulgaria; Recruiting

Investigational Site, Burgas 8000, Bulgaria; Recruiting

Investigational Site, Tartu 51014, Estonia; Recruiting

Investigational Site, Tallinn 13419, Estonia; Recruiting

Investigational Site, Tallinn 10138, Estonia; Recruiting

Investigational Site, Annecy 74000, France; Recruiting

Investigational Site, Argenteuil 95100, France; Recruiting

Investigational Site, Paris 750120, France; Recruiting

Investigational Site, Paris 75674, France; Recruiting

Investigational Site, Paris 75475, France; Recruiting

Investigational Site, Tbilisi 0144, Georgia; Recruiting

Investigational Site, Tbilisi 0160, Georgia; Recruiting

Investigational Site, Lubeck 23538, Germany; Recruiting

Investigational Site, Wiesbaden 65199, Germany; Recruiting

Investigational Site, Luedenscheid 58515, Germany; Recruiting

Investigational Site, Bochum 44793, Germany; Recruiting

Investigational Site, Ulm 89081, Germany; Recruiting

Investigational Site, Heppenheim 64646, Germany; Recruiting

Investigational Site, Lich 53545, Germany; Recruiting

Investigational Site, Schkeuditz 04435, Germany; Recruiting

Investigational Site, Paderborn 33098, Germany; Recruiting

Investigational Site, Berlin 13353, Germany; Recruiting

Investigational Site, Bochum 44879, Germany; Recruiting

Investigational Site, Erfurt 99089, Germany; Recruiting

Investigational Site, Torokbalint 2045, Hungary; Recruiting

Investigational Site, Matrahaza 3233, Hungary; Recruiting

Investigational Site, Pecs 7623, Hungary; Recruiting

Investigational Site, Miskolc 3529, Hungary; Recruiting

Investigational Site, Budapest 1125, Hungary; Recruiting

Investigational Site, Sopron 9400, Hungary; Recruiting

Investigational Site, Tatabanya 2800, Hungary; Recruiting

Investigational Site, Kaunas LT-45130, Lithuania; Recruiting

Investigational Site, Vilnius LT-10207, Lithuania; Recruiting

Investigational Site, Kaunas LT-50009, Lithuania; Recruiting

Investigational Site, Siauliai LT-76231, Lithuania; Recruiting

Investigational Site, Klaipeda LT-92231, Lithuania; Recruiting

Investigational Site, Klaipeda LT-92288, Lithuania; Recruiting

Investigational Site, Kedah 05460, Malaysia; Recruiting

Investigational Site, Kuala Lumpur 50590, Malaysia; Recruiting

Investigational Site, Chodziez 64-800, Poland; Recruiting

Investigational Site, Bedzin 42-500, Poland; Recruiting

Investigational Site, Warszawa 127 02-507, Poland; Recruiting

Investigational Site, Poznan 60-569, Poland; Recruiting

Investigational Site, Warszawa 03-401, Poland; Recruiting

Investigational Site, Czestochowa 42-200, Poland; Recruiting

Investigational Site, Warszawa 01-138, Poland; Recruiting

Investigational Site, Tychy 43-100, Poland; Recruiting

Investigational Site, Warszawa 03-737, Poland; Recruiting

Investigational Site, Poznan 60-479, Poland; Recruiting

Investigational Site, Bytom 41-902, Poland; Recruiting

Investigational Site, Krakow 30-053, Poland; Recruiting

Investigational Site, Katowice-Ochojec 40-635, Poland; Recruiting

Investigational Site, Brzesku 32-800, Poland; Recruiting

Investigational Site, Wroclaw 53-439, Poland; Recruiting

Investigational Site, Lublin 20-178, Poland; Recruiting

Investigational Site, Lublin 20-718, Poland; Recruiting

Inestigational Site, Bucharest 042122, Romania; Recruiting

Investigational Site, St. Brasov 25-27, Romania; Recruiting

Investigational Site, Oradea 410176, Romania; Recruiting

Investigational Site, Targu Mures 540136, Romania; Recruiting

Investigational Site, Cluj Napoca 400238, Romania; Recruiting

Investigational Site, Timisoara, Romania; Recruiting

Investigational Site, Constanta, Romania; Recruiting

Investigational Site, Bucharest 050098, Romania; Recruiting

Investigational Site, Rostov-on-Don 344010, Russian Federation; Recruiting

Investigational Site, Yekaterinburg 620109, Russian Federation; Recruiting

Investigational Site, St Petersburg 194354, Russian Federation; Recruiting

Investigational Site, Moscow 123182, Russian Federation; Recruiting

Investigational Site, St. Petersburg 195257, Russian Federation; Recruiting

Investigational Site, Moscow 119048, Russian Federation; Recruiting

Investigational Site, Yekaterinburg 620137, Russian Federation; Recruiting

Investigational Site, Moscow 125206, Russian Federation; Recruiting

Investigational Site, Arkhangelsk 163045, Russian Federation; Recruiting

Investigational Site, St. Petersburg 191104, Russian Federation; Recruiting

Investigational Site, Tatarstan 420-101, Russian Federation; Recruiting

Investigational Site, Saratov 410-002, Russian Federation; Recruiting

Investigational Site, Kragujevac 34000, Serbia; Recruiting

Investigational Site, Belgrade 11080, Serbia; Recruiting

Investigational Site, Knez Selo 18204, Serbia; Recruiting

Slovakia, Nitra-Zobor 948 88, Slovakia; Recruiting

Investigational Site, Bratislava 813 69, Slovakia; Recruiting

Investigational Site, Cape Town 7530, South Africa; Recruiting

Investigational Site, Pretoria 0084, South Africa; Recruiting

Investigational Site, Pretoria 0140, South Africa; Recruiting

Investigational Site, Pretoria 0188, South Africa; Recruiting

Investigational Site, Port Elizabeth 6020, South Africa; Recruiting

Investigational Site, Pretoria 0001, South Africa; Recruiting

Investigational Site, Benomi 1500, South Africa; Recruiting

Investigational Site, Somerset West 7130, South Africa; Recruiting

Investigational Site, Krugersdorp 1752, South Africa; Recruiting

Investigational Site, Cape Town 7505, South Africa; Recruiting

Investigational Site, Worcester 6850, South Africa; Recruiting

Investigational Site, Barcelona 08035, Spain; Recruiting

Investigational Site, Madrid 28007, Spain; Recruiting

Investigational Site, Vizcaya 48960, Spain; Recruiting

Investigational Site, Valencia 46009, Spain; Recruiting

Investigational Site, Leon 24411, Spain; Recruiting

Investigational Site, Barcelona 08036, Spain; Recruiting

Investigational Site, Elche 03203, Spain; Recruiting

Investigational Site, Biel 2501, Switzerland; Recruiting

Investigational Site, La Chaux-de-Fonds 2300, Switzerland; Recruiting

Investigational Site, Geneve 1211, Switzerland; Recruiting

Investigational Site, Lugano 46,6903, Switzerland; Recruiting

Investigational Site, Bangkok 10700, Thailand; Recruiting

Investigational Site, Nonthaburi 11000, Thailand; Recruiting

Investigational Site, Khonkaen 40002, Thailand; Recruiting

Investigational Site, Chiang Mai 50200, Thailand; Recruiting

Investigational Site, Bangkok 10110, Thailand; Recruiting

Investigational Site, Bangkok 10400, Thailand; Recruiting

InvestigationalSite, Bangkok 10400, Thailand; Recruiting

Investigational Site, Kyiv 03680, Ukraine; Recruiting

Investigational Site, Aviv 79013, Ukraine; Recruiting

Investigational Site, Poltava 36038, Ukraine; Recruiting

Investigational Site, Odesa 65025, Ukraine; Recruiting

Investigational Site, Kharkiv 61018, Ukraine; Recruiting

Investigational Site, Lugansk 91045, Ukraine; Recruiting

Inestigational Site, Kyiv 02091, Ukraine; Recruiting

Investigational Site, Donetsk 83099, Ukraine; Recruiting

Investigational Site, Dnipropetrovsk 49074, Ukraine; Recruiting

Investigational Site, Kharkiv 61035, Ukraine; Recruiting

Investigational Site, Uzhorod 88015, Ukraine; Recruiting

Investigational Site, Ivano-Frankivsk 76025, Ukraine; Recruiting

Investigational Site, Dnipropetrovsk 49102, Ukraine; Recruiting

Investigational Site, Buenos Aires, C.a.B.a. C1431FWO, Argentina; Recruiting

Investigational Site, Pasadena, California 91105, United States; Recruiting

Investigational Site, San Diego, California 92114, United States; Recruiting

Investigational site, Los Angeles, California 90015, United States; Recruiting

Investigational Site, Sacramento, California 95817, United States; Recruiting

Investigational Site, Bellville, Capetown 7530, South Africa; Recruiting

Investigational Site, Orlando, Florida 32806, United States; Recruiting

Investigational Site, Goiania, G.O. 74465-539, Brazil; Recruiting

Investigational Site, Fort Gordon, Georgia 30905, United States; Recruiting

Investigational Site, Peoria, Illinois 61603, United States; Recruiting

Investigational Site, Johor Bahru, Johor 80100, Malaysia; Recruiting

Inestigational Site, Cheras, Kuala Lumpur 05460, Malaysia; Recruiting

Investigational Site, Baltimore, Maryland 21237, United States; Recruiting

Investigational site, Minneapolis, Minnesota 55422, United States; Recruiting

Investigational Site, Butte, Montana 59701, United States; Recruiting

Investigational Site, Akron, Ohio 44305, United States; Recruiting

Investigational Site, Georgetown, Penang 10990, Malaysia; Recruiting

Investigational Site, Porto Alegre, RS 90610-001, Brazil; Recruiting

Investigational Site, Porto Alegre, RS 90020-090, Brazil; Recruiting

Investigational Site, Petrozavodsk, Republic of Karelia 185014, Russian Federation; Recruiting

Investigational Site, Sao Jose do Rio Preto, SP 15090-000, Brazil; Recruiting

Investigational Site, Tatabanya, Szanatorium 2800, Hungary; Recruiting

Investigational Site, Houston, Texas 77030, United States; Recruiting

Investigational Site, San Miguel de Tucuman, Tucuman T4000IIH, Argentina; Recruiting

Starting date: December 2007
Last updated: October 27, 2008