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Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01499277
First received: December 16, 2011
Last updated: November 18, 2015
Last verified: November 2015
Results First Received: June 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Complicated Skin and Soft Tissue Infection
Interventions: Drug: Ceftaroline fosamil
Drug: Vancomycin
Drug: Aztreonam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall, 802 patients were enrolled from 111 centres in 6 regions in this study. The first patient was enrolled on 17 May 2012 and the last patient last visit was on 26 June 2014. Of 802 enrolled participants, 30 did not meet the eligibility criteria and 11 were randomized but not treated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ceftaroline Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin/Aztreonam Vancomycin Plus Aztreonam

Participant Flow:   Overall Study
    Ceftaroline     Vancomycin/Aztreonam  
STARTED     506     255  
COMPLETED     459     223  
NOT COMPLETED     47     32  
Adverse Event                 3                 6  
Death                 3                 2  
Lost to Follow-up                 15                 8  
Protocol Violation                 2                 3  
Withdrawal by Subject                 16                 6  
Lack of therapeutic response and other                 8                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
761 randomized patients who received any amount of study therapy. there are 11 patients who are randomized , but didn't receive any study therapy.

Reporting Groups
  Description
Ceftaroline Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin/Aztreonam Vancomycin Plus Aztreonam
Total Total of all reporting groups

Baseline Measures
    Ceftaroline     Vancomycin/Aztreonam     Total  
Number of Participants  
[units: participants]
  506     255     761  
Age  
[units: Years]
Mean (Standard Deviation)
  52.6  (16.51)     53.6  (16.25)     52.9  (16.42)  
Gender  
[units: Participants]
     
Female     196     107     303  
Male     310     148     458  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set   [ Time Frame: 7 to 20 days after the last dose of study drug ]

2.  Primary:   Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set   [ Time Frame: 7 to 20 days after the last dose of study drug ]

3.  Secondary:   Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set   [ Time Frame: 7 to 20 days after the last dose of study drug ]

4.  Secondary:   Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set   [ Time Frame: 7 to 20 days after the last dose of study drug ]

5.  Secondary:   Clinical Response at End of Treatment (EOT) in MITT Analysis Set   [ Time Frame: On day of last dose of study drug (or + 1 day) ]

6.  Secondary:   Clinical Response at EOT in CE Analysis Set   [ Time Frame: On day of last dose of study drug (or +1 day) ]

7.  Secondary:   Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC   [ Time Frame: 21 to 42 days after the last dose of study drug ]

8.  Secondary:   Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set   [ Time Frame: 48 to 72 hours after first dose of study drug ]

9.  Secondary:   Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME   [ Time Frame: 7 to 20 days after the last dose of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Yunxia Lu
Organization: AstraZeneca-PPD
phone: 910-558-4197
e-mail: Yunxia.Lu@ppdi.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01499277     History of Changes
Other Study ID Numbers: D3720C00001
2011-004013-16
Study First Received: December 16, 2011
Results First Received: June 23, 2015
Last Updated: November 18, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ministry of Health and Social Care
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration