Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00230971
First received: September 30, 2005
Last updated: February 20, 2013
Last verified: February 2013
Results First Received: September 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Appendicitis
Cholecystitis
Diverticulitis
Intra-Abdominal Abscess
Intra-Abdominal Infection
Peritonitis
Interventions: Drug: tigecycline
Drug: ceftriaxone plus metronidazole

  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
Patients were recruited worldwide from November 2005 to July 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened according to the inclusion/exclusion criteria. Once informed consent was obtained, the patient was enrolled into the study and assigned a randomization number and a treatment regimen.

Reporting Groups
  Description
Tigecycline Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
Ceftriaxone Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.

Participant Flow for 2 periods

Period 1:   Randomization
    Tigecycline     Ceftriaxone  
STARTED     235     238  
COMPLETED     232     235  
NOT COMPLETED     3     3  
No study drug administered                 3                 3  

Period 2:   Baseline Participants
    Tigecycline     Ceftriaxone  
STARTED     232     235  
COMPLETED     210     216  
NOT COMPLETED     22     19  
Lost to Follow-up                 5                 12  
Death                 6                 5  
Withdrawal by Subject                 7                 1  
Adverse Event                 1                 0  
No bacteria observed                 1                 0  
Failure to return                 1                 1  
Reintervention                 1                 0  



  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.
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Reporting Groups
  Description
Tigecycline Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
Ceftriaxone Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
Total Total of all reporting groups

Baseline Measures
    Tigecycline     Ceftriaxone     Total  
Number of Participants  
[units: participants]
  232     235     467  
Age  
[units: years]
Mean ± Standard Deviation
  48.55  ± 18.37     46.81  ± 18.38     47.67  ± 18.37  
Gender  
[units: participants]
     
Female     80     72     152  
Male     152     163     315  



  Outcome Measures
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1.  Primary:   Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit   [ Time Frame: up to 6 weeks ]

2.  Secondary:   Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit   [ Time Frame: up to 6 weeks ]

3.  Secondary:   Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit   [ Time Frame: up to 6 weeks ]

4.  Secondary:   Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure   [ Time Frame: up to 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00230971     History of Changes
Other Study ID Numbers: 3074A1-315
Study First Received: September 30, 2005
Results First Received: September 30, 2009
Last Updated: February 20, 2013
Health Authority: European Union: European Medicines Agency
Australia: Human Research Ethics Committee
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
India: Institutional Review Board
Republic of the Philippines: Ethics Committee
Taiwan: Institutional Review Board
Denmark: Ethics Committee
Finland: National Advisory Board on Health Care Ethics
France: Institutional Ethical Committee
Germany: Ethics Commission
Greece: Ethics Committee
Italy: Ethics Committee
Saudi Arabia: Ethics Committee
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Switzerland: Ethikkommission
Turkey: Ministry of Health
United Kingdom: Research Ethics Committee