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Bacterial PneumoniaPhase 3CAPNCT00621504

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

A Phase 3 study testing Ceftaroline fosamil for Injection, IV Ceftriaxone and Clarithromycin in people with Bacterial Pneumonia, run by Forest Laboratories at 168 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Bacterial Pneumonia
What is being tested?
Ceftaroline fosamil for Injection, IV Ceftriaxone and Clarithromycin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
606 participants
Where
168 sitesin 23 countries
Study dates
Jan 2008to Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

168 sites in 23 countries.

168 sites in 23 countries

Poland17 sites

  • Investigational Site

    Będzin, 42-500

  • Investigational Site

    Brzesku, 32-800

  • Investigational Site

    Bytom, 41-902

  • Investigational Site

    Chodzież, 64-800

  • Investigational Site

    Częstochowa, 42-200

  • Investigational Site

    Katowice-Ochojec, 40-635

  • Investigational Site

    Krakow, 30-053

  • Investigational Site

    Lublin, 20-178

  • Investigational Site

    Lublin, 20-718

  • Investigational Site

    Poznan, 60-479

  • Investigational Site

    Poznan, 60-569

  • Investigational Site

    Tychy, 43-100

  • Investigational Site

    Warsaw, 01-138

  • Investigational Site

    Warsaw, 03-401

  • Investigational Site

    Warsaw, 03-737

  • Investigational Site

    Warsaw, 127 02-507

  • Investigational Site

    Wroclaw, 53-439

Other trials in Poland

Germany13 sites

  • Investigational Site

    Berlin, 13353

  • Investigational Site

    Bochum, 44793

  • Investigational Site

    Bochum, 44879

  • Investigational Site

    Erfurt, 99089

  • Investigational Site

    Heppenheim an der Bergstrasse, 64646

  • Investigational Site

    Lich, 53545

  • Investigational Site

    Lindenberger, State of Berlin, 13125

  • Investigational Site

    Lübeck, 23538

  • Investigational Site

    Lüdenscheid, 58515

  • Investigational Site

    Paderborn, 33098

  • Investigational Site

    Schkeuditz, 04435

  • Investigational Site

    Ulm, 89081

  • Investigational Site

    Wiesbaden, 65199

Other trials in Germany

Russia13 sites

  • Investigational Site

    Arkhangelsk, 163045

  • Investigational Site

    Moscow, 119048

  • Investigational Site

    Moscow, 123182

  • Investigational Site

    Moscow, 125206

  • Investigational Site

    Petrozavodsk, Republic of Karelia, 185014

  • Investigational Site

    Rostov-on-Don, 344010

  • Investigational Site

    Saint Petersburg, 191104

  • Investigational Site

    Saint Petersburg, 194354

  • Investigational Site

    Saint Petersburg, 195257

  • Investigational Site

    Saratov, 410-002

  • Investigational Site

    Tatarstan, 420-101

  • Investigational Site

    Yekaterinburg, 620109

  • Investigational Site

    Yekaterinburg, 620137

Other trials in Russia

Ukraine13 sites

  • Investigational Site

    Aviv, 79013

  • Investigational Site

    Dnipropetrovsk, 49074

  • Investigational Site

    Dnipropetrovsk, 49102

  • Investigational Site

    Donetsk, 83099

  • Investigational Site

    Ivano-Frankivsk, 76025

  • Investigational Site

    Kharkiv, 61018

  • Investigational Site

    Kharkiv, 61035

  • Inestigational Site

    Kyiv, 02091

  • Investigational Site

    Kyiv, 03680

  • Investigational Site

    Luhansk, 91045

  • Investigational Site

    Odesa, 65025

  • Investigational Site

    Poltava, 36038

  • Investigational Site

    Uzhhorod, 88015

Other trials in Ukraine

United States12 sites

  • Investigational Site

    Akron, Ohio, 44305

  • Investigational Site

    Baltimore, Maryland, 21237

  • Investigational Site

    Butte, Montana, 59701

  • Investigational Site

    Fort Gordon, Georgia, 30905

  • Investigational Site

    Houston, Texas, 77030

  • Investigational site

    Los Angeles, California, 90015

  • Investigational site

    Minneapolis, Minnesota, 55422

  • Investigational Site

    Orlando, Florida, 32806

  • Investigational Site

    Pasadena, California, 91105

  • Investigational Site

    Peoria, Illinois, 61603

  • Investigational Site

    Sacramento, California, 95817

  • Investigational Site

    San Diego, California, 92114

Other trials in United States

Brazil12 sites

  • Investigational Site 2

    Belo Horizonte, 30140-062

  • Investigational Site 1

    Belo Horizonte MG, 30150-221

  • Investigational Site

    Campinas, SP 13059-900

  • Investigational Site

    Curitiba-PR, 80810-040

  • Investigational Site

    Goiânia, G.o., 74465-539

  • Investigational Site

    Juiz de Fora, 36036-110

  • Investigational Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610-001

  • Investigational site

    Porto Alegre, 90035-001

  • Investigational Site

    São José do Rio Preto, São Paulo, 15090-000

  • Investigational Site

    São Paulo, 04038-905

  • Investigational Site

    São Paulo, 17201-340

Other trials in Brazil

South Africa12 sites

  • Investigational Site

    Bellville, Capetown, 7530

  • Investigational Site

    Benomi, 1500

  • Investigational Site

    Cape Town, 7505

  • Investigational Site

    Cape Town, 7530

  • Investigational Site

    Krugersdorp, 1752

  • Investigational Site

    Port Elizabeth, 6020

  • Investigational Site

    Pretoria, 0001

  • Investigational Site

    Pretoria, 0084

  • Investigational Site

    Pretoria, 0140

  • Investigational Site

    Pretoria, 0188

  • Investigational Site

    Somerset West, 7130

  • Investigational Site

    Worcester, 6850

Other trials in South Africa

Argentina10 sites

  • Investigational Site

    Buenos Aires, C.a.b.a., C1431FWO

  • Investigational Site

    Buenos Aires, 1650

  • Investigational Site

    Buenos Aires, 1748

  • Investigational Site

    Buenos Aires, B1702FWM

  • Investigational Site

    Buenos Aires, B6700AQJ

  • Investigational Site

    Buenos Aires, C1155ADP

  • Investigational Site

    Buenos Aires, C1430BKC

  • Investigational Site

    Buenos Aires, C1437 BZK

  • Investigational Site

    San Miguel de Tucumán, Tucumán Province, T4000IIH

  • Investigational Site

    Vicente López, 1602

Other trials in Argentina

Hungary8 sites

  • Investigational Site

    Budapest, 1125

  • Investigational Site

    Mátraháza, 3233

  • Investigational Site

    Miskolc, 3529

  • Investigational Site

    Pécs, 7623

  • Investigational Site

    Sopron, 9400

  • Investigational Site

    Tatabánya, Szanatorium, 2800

  • Investigational Site

    Tatabánya, 2800

  • Investigational Site

    Törökbálint, 2045

Other trials in Hungary

Romania8 sites

  • Inestigational Site

    Bucharest, 042122

  • Investigational Site

    Bucharest, 050098

  • Investigational Site

    Cluj-Napoca, 400238

  • Investigational Site

    Constanța

  • Investigational Site

    Oradea, 410176

  • Investigational Site

    Saint Brasov, 25-27

  • Investigational Site

    Târgu Mureş, 540136

  • Investigational Site

    Timișoara

Other trials in Romania

Spain7 sites

  • Investigational Site

    Barcelona, 08035

  • Investigational Site

    Barcelona, 08036

  • Investigational Site

    Elche, 03203

  • Investigational Site

    León, 24411

  • Investigational Site

    Madrid, 28007

  • Investigational Site

    Valencia, 46009

  • Investigational Site

    Vizcaya, 48960

Other trials in Spain

Thailand7 sites

  • Investigational Site

    Bangkok, 10110

  • Investigational Site

    Bangkok, 10400

  • InvestigationalSite

    Bangkok, 10400

  • Investigational Site

    Bangkok, 10700

  • Investigational Site

    Chiang Mai, 50200

  • Investigational Site

    Khonkaen, 40002

  • Investigational Site

    Nonthaburi, 11000

Other trials in Thailand

Lithuania6 sites

  • Investigational Site

    Kaunas, LT-45130

  • Investigational Site

    Kaunas, LT-50009

  • Investigational Site

    Klaipėda, LT-92231

  • Investigational Site

    Klaipėda, LT-92288

  • Investigational Site

    Šiauliai, LT-76231

  • Investigational Site

    Vilnius, LT-10207

Other trials in Lithuania

France5 sites

  • Investigational Site

    Annecy, 74000

  • Investigational Site

    Argenteuil, 95100

  • Investigational Site

    Paris, 750120

  • Investigational Site

    Paris, 75475

  • Investigational Site

    Paris, 75674

Other trials in France

Malaysia5 sites

  • Inestigational Site

    Cheras, Kuala Lumpur, 05460

  • Investigational Site

    George Town, Pulau Pinang, 10990

  • Investigational Site

    Johor Bahru, Johor, 80100

  • Investigational Site

    Kedah, 05460

  • Investigational Site

    Kuala Lumpur, 50590

Other trials in Malaysia

Switzerland4 sites

  • Investigational Site

    Biel, 2501

  • Investigational Site

    Geneva, 1211

  • Investigational Site

    La Chaux-de-Fonds, 2300

  • Investigational Site

    Lugano, 46,6903

Other trials in Switzerland

Bulgaria3 sites

  • Investigational Site

    Burgas, 8000

  • Investigational Site

    Sofia, 1431

  • Investigational Site

    Varna, 9010

Other trials in Bulgaria

Estonia3 sites

  • Investigational Site

    Tallinn, 10138

  • Investigational Site

    Tallinn, 13419

  • Investigational Site

    Tartu, 51014

Other trials in Estonia

Serbia3 sites

  • Investigational Site

    Belgrade, 11080

  • Investigational Site

    Knez-Selo, 18204

  • Investigational Site

    Kragujevac, 34000

Other trials in Serbia

Austria2 sites

  • Investigational Site

    Vienna, A-1030

  • Investigational Site

    Vienna, A-1090

Other trials in Austria

Georgia2 sites

  • Investigational Site

    Tbilisi, 0144

  • Investigational Site

    Tbilisi, 0160

Other trials in Georgia

Slovakia2 sites

  • Investigational Site

    Bratislava, 813 69

  • Slovakia

    Nitra-Zobor, 948 88

Other trials in Slovakia

India1 site

  • Investigational Site

    Vellore, Tamil Nadu, 632004

Other trials in India

About this study

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

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

Read the 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

Being tested
Ceftaroline fosamil for Injection, IV Ceftriaxone, Placebo, Clarithromycin
Keywords
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
Medical subject headings
Pneumonia, Bacterial, Community-Acquired Pneumonia, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ceftaroline fosamil for InjectionDrug

    2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days

  • IV CeftriaxoneDrug

    Also called Ceftriaxone

    1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days

  • PlaceboDrug

    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

  • ClarithromycinDrug

    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.

Study groups in NCT00621504
Study groupRoleWhat they receive
Ceftaroline fosamil for InjectionExperimentalCeftaroline 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.
Receives: Drug: Ceftaroline fosamil for Injection; Drug: Clarithromycin
IV CeftriaxoneActive comparatorCeftriaxone 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.
Receives: Drug: IV Ceftriaxone; Drug: Placebo; Drug: Clarithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations

    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

    Measured: 8 to 15 days after last dose of study drug

  2. Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population

    Measured: 8-15 days after last dose of study drug

Secondary outcomes (7)

  1. Clinical Response at End of Therapy (EOT)

    Measured: Last day of study drug administration

  2. Microbiological Success Rate at Test of Cure (TOC)

    Measured: 8-15 days after last dose of study drug

  3. Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)

    Measured: 8-15 days after last day of study drug

  4. Clinical and Microbiological Response by Pathogen at TOC

    Measured: 8-15 days after last dose of study drug

  5. Clinical Relapse at Late Follow Up (LFU)

    Measured: 21-35 days after last dose of study drug

  6. Microbiological Re-infection/Recurrence at LFU

    Measured: 21 to 35 days after last dose of study drug

  7. Evaluate Safety

    Measured: first dose, throughout the treatment period, and up to the TOC visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2008
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00621504
Sponsor's protocol ID
P903-08
Acronym
CAP
Status last verified
Feb 2017
First submitted
11 Feb 2008
Last updated
14 Mar 2017
Data monitoring committee
No

Publications

  • Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.

    PubMed 34922058

  • Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.

    PubMed 30597021

  • Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24.

    PubMed 26702925

  • Lodise TP, Anzueto AR, Weber DJ, Shorr AF, Yang M, Smith A, Zhao Q, Huang X, File TM. Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials. Antimicrob Agents Chemother. 2015 Feb;59(2):1119-26. doi: 10.1128/AAC.03643-14. Epub 2014 Dec 8.

    PubMed 25487791

  • Shorr AF, Kollef M, Eckburg PB, Llorens L, Friedland HD. Assessment of ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized trials. Diagn Microbiol Infect Dis. 2013 Mar;75(3):298-303. doi: 10.1016/j.diagmicrobio.2012.12.002. Epub 2013 Jan 26.

    PubMed 23357290

  • Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii53-9. doi: 10.1093/jac/dkr099.

    PubMed 21482570

  • File TM Jr, Low DE, Eckburg PB, Talbot GH, Friedland HD, Lee J, Llorens L, Critchley IA, Thye DA; FOCUS 1 investigators. FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii19-32. doi: 10.1093/jac/dkr096.

    PubMed 21482566

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ceftaroline fosamil for Injection, IV Ceftriaxone and Clarithromycin in people with Bacterial Pneumonia, run by Forest Laboratories at 168 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in Poland, Germany, Russia, Ukraine, United States and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00621504, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.

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