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

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ClinicalTrials.gov Identifier: NCT00621504
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : November 10, 2010
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Drug: Ceftaroline fosamil for Injection Drug: IV Ceftriaxone Drug: Placebo Drug: Clarithromycin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009


Arm Intervention/treatment
Experimental: Ceftaroline fosamil for Injection

Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h).

In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Drug: Ceftaroline fosamil for Injection
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days

Drug: Clarithromycin
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Active Comparator: IV Ceftriaxone

Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).

In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Drug: IV Ceftriaxone
1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days
Other Name: Ceftriaxone

Drug: Placebo
Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind

Drug: Clarithromycin
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.




Primary Outcome Measures :
  1. Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations [ Time Frame: 8 to 15 days after last dose of study drug ]

    Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary

    Failure: Any of the following:

    • Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
    • Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
    • Death wherein pneumonia (ie,CABP) was considered causative

    Indeterminate: Inability to determine an outcome


  2. Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population [ Time Frame: 8-15 days after last dose of study drug ]

Secondary Outcome Measures :
  1. Clinical Response at End of Therapy (EOT) [ Time Frame: Last day of study drug administration ]
  2. Microbiological Success Rate at Test of Cure (TOC) [ Time Frame: 8-15 days after last dose of study drug ]
  3. Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) [ Time Frame: 8-15 days after last day of study drug ]
  4. Clinical and Microbiological Response by Pathogen at TOC [ Time Frame: 8-15 days after last dose of study drug ]
  5. Clinical Relapse at Late Follow Up (LFU) [ Time Frame: 21-35 days after last dose of study drug ]
  6. Microbiological Re-infection/Recurrence at LFU [ Time Frame: 21 to 35 days after last dose of study drug ]
  7. Evaluate Safety [ Time Frame: first dose, throughout the treatment period, and up to the TOC visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621504


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Locations
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United States, California
Investigational site
Los Angeles, California, United States, 90015
Investigational Site
Pasadena, California, United States, 91105
Investigational Site
Sacramento, California, United States, 95817
Investigational Site
San Diego, California, United States, 92114
United States, Florida
Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
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Fort Gordon, Georgia, United States, 30905
United States, Illinois
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Peoria, Illinois, United States, 61603
United States, Maryland
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Baltimore, Maryland, United States, 21237
United States, Minnesota
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Minneapolis, Minnesota, United States, 55422
United States, Montana
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Butte, Montana, United States, 59701
United States, Ohio
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Akron, Ohio, United States, 44305
United States, Texas
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Houston, Texas, United States, 77030
Argentina
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Buenos Aires, C.a.b.a., Argentina, C1431FWO
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San Miguel de Tucuman, Tucuman, Argentina, T4000IIH
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Buenos Aires, Argentina, 1650
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Buenos Aires, Argentina, 1748
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Buenos Aires, Argentina, B1702FWM
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Buenos Aires, Argentina, B6700AQJ
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Buenos Aires, Argentina, C1155ADP
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Buenos Aires, Argentina, C1430BKC
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Buenos Aires, Argentina, C1437 BZK
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Vicente Lopez, Argentina, 1602
Austria
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Vienna, Austria, A-1090
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Wien, Austria, A-1030
Brazil
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Goiania, G.o., Brazil, 74465-539
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Porto Alegre, RS, Brazil, 90020-090
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Porto Alegre, RS, Brazil, 90610-001
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Sao Jose do Rio Preto, SP, Brazil, 15090-000
Investigational Site 1
Belo Horizonte MG, Brazil, 30150-221
Investigational Site 2
Belo Horizonte, Brazil, 30140-062
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Campinas, Brazil, SP 13059-900
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Curitiba-PR, Brazil, 80810-040
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Juiz de Fora, Brazil, 36036-110
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Porto Alegre, Brazil, 90035-001
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Sao Paolo, Brazil, 04038-905
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Sao Paolo, Brazil, 17201-340
Bulgaria
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Burgas, Bulgaria, 8000
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Sofia, Bulgaria, 1431
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Varna, Bulgaria, 9010
Estonia
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Tallinn, Estonia, 10138
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Tallinn, Estonia, 13419
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Tartu, Estonia, 51014
France
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Annecy, France, 74000
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Argenteuil, France, 95100
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Paris, France, 750120
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Paris, France, 75475
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Paris, France, 75674
Georgia
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Tbilisi, Georgia, 0144
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Tbilisi, Georgia, 0160
Germany
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Lindenberger, Berlin, Germany, 13125
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Berlin, Germany, 13353
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Bochum, Germany, 44793
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Bochum, Germany, 44879
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Erfurt, Germany, 99089
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Heppenheim, Germany, 64646
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Lich, Germany, 53545
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Lubeck, Germany, 23538
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Luedenscheid, Germany, 58515
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Paderborn, Germany, 33098
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Schkeuditz, Germany, 04435
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Ulm, Germany, 89081
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Wiesbaden, Germany, 65199
Hungary
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Tatabanya, Szanatorium, Hungary, 2800
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Budapest, Hungary, 1125
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Matrahaza, Hungary, 3233
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Miskolc, Hungary, 3529
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Pecs, Hungary, 7623
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Sopron, Hungary, 9400
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Tatabanya, Hungary, 2800
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Torokbalint, Hungary, 2045
India
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Vellore, Tamilnadu, India, 632004
Lithuania
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Kaunas, Lithuania, LT-45130
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Kaunas, Lithuania, LT-50009
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Klaipeda, Lithuania, LT-92231
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Klaipeda, Lithuania, LT-92288
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Siauliai, Lithuania, LT-76231
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Vilnius, Lithuania, LT-10207
Malaysia
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Johor Bahru, Johor, Malaysia, 80100
Inestigational Site
Cheras, Kuala Lumpur, Malaysia, 05460
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Georgetown, Penang, Malaysia, 10990
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Kedah, Malaysia, 05460
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Kuala Lumpur, Malaysia, 50590
Poland
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Bedzin, Poland, 42-500
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Brzesku, Poland, 32-800
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Bytom, Poland, 41-902
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Chodziez, Poland, 64-800
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Czestochowa, Poland, 42-200
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Katowice-Ochojec, Poland, 40-635
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Krakow, Poland, 30-053
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Lublin, Poland, 20-178
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Lublin, Poland, 20-718
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Poznan, Poland, 60-479
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Poznan, Poland, 60-569
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Tychy, Poland, 43-100
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Warszawa, Poland, 01-138
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Warszawa, Poland, 03-401
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Warszawa, Poland, 03-737
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Warszawa, Poland, 127 02-507
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Wroclaw, Poland, 53-439
Romania
Inestigational Site
Bucharest, Romania, 042122
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Bucharest, Romania, 050098
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Cluj Napoca, Romania, 400238
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Constanta, Romania
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Oradea, Romania, 410176
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St. Brasov, Romania, 25-27
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Targu Mures, Romania, 540136
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Timisoara, Romania
Russian Federation
Investigational Site
Petrozavodsk, Republic of Karelia, Russian Federation, 185014
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Arkhangelsk, Russian Federation, 163045
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Moscow, Russian Federation, 119048
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Moscow, Russian Federation, 123182
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Moscow, Russian Federation, 125206
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Rostov-on-Don, Russian Federation, 344010
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Saratov, Russian Federation, 410-002
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St Petersburg, Russian Federation, 194354
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St. Petersburg, Russian Federation, 191104
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St. Petersburg, Russian Federation, 195257
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Tatarstan, Russian Federation, 420-101
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Yekaterinburg, Russian Federation, 620109
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Yekaterinburg, Russian Federation, 620137
Serbia
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Belgrade, Serbia, 11080
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Knez Selo, Serbia, 18204
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Kragujevac, Serbia, 34000
Slovakia
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Bratislava, Slovakia, 813 69
Slovakia
Nitra-Zobor, Slovakia, 948 88
South Africa
Investigational Site
Bellville, Capetown, South Africa, 7530
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Benomi, South Africa, 1500
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Cape Town, South Africa, 7505
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Cape Town, South Africa, 7530
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Krugersdorp, South Africa, 1752
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Port Elizabeth, South Africa, 6020
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Pretoria, South Africa, 0001
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Pretoria, South Africa, 0084
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Pretoria, South Africa, 0140
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Pretoria, South Africa, 0188
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Somerset West, South Africa, 7130
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Worcester, South Africa, 6850
Spain
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Barcelona, Spain, 08035
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Barcelona, Spain, 08036
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Elche, Spain, 03203
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Leon, Spain, 24411
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Madrid, Spain, 28007
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Valencia, Spain, 46009
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Vizcaya, Spain, 48960
Switzerland
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Biel, Switzerland, 2501
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Geneve, Switzerland, 1211
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La Chaux-de-Fonds, Switzerland, 2300
Investigational Site
Lugano, Switzerland, 46,6903
Thailand
Investigational Site
Bangkok, Thailand, 10110
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50200
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Khonkaen, Thailand, 40002
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Nonthaburi, Thailand, 11000
Ukraine
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Aviv, Ukraine, 79013
Investigational Site
Dnipropetrovsk, Ukraine, 49074
Investigational Site
Dnipropetrovsk, Ukraine, 49102
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Donetsk, Ukraine, 83099
Investigational Site
Ivano-Frankivsk, Ukraine, 76025
Investigational Site
Kharkiv, Ukraine, 61018
Investigational Site
Kharkiv, Ukraine, 61035
Inestigational Site
Kyiv, Ukraine, 02091
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Kyiv, Ukraine, 03680
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Lugansk, Ukraine, 91045
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Odesa, Ukraine, 65025
Investigational Site
Poltava, Ukraine, 36038
Investigational Site
Uzhorod, Ukraine, 88015
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Thomas M File, MD, MS Summa Health System

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00621504     History of Changes
Other Study ID Numbers: P903-08
First Posted: February 22, 2008    Key Record Dates
Results First Posted: November 10, 2010
Last Update Posted: March 14, 2017
Last Verified: February 2017

Keywords provided by Forest Laboratories:
ceftaroline
Community-acquired pneumonia
CAP
IV (intravenous)
Streptococcus pneumoniae
Haemophilus influenzae
Mycoplasma pneumoniae
Chlamydophila spp
Legionella spp
Multi-drug resistant Streptococcus pneumoniae (MDRSP)
antimicrobial resistance
pneumococci
Ceftriaxone
bacteria
ß-lactam
beta-lactam
antibiotic

Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Clarithromycin
Ceftriaxone
Ceftaroline fosamil
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors