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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00230971
Registration number
NCT00230971
Ethics application status
Date submitted
30/09/2005
Date registered
3/10/2005
Date last updated
25/02/2013
Titles & IDs
Public title
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
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Scientific title
A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection
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Secondary ID [1]
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3074A1-315
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Appendicitis
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Cholecystitis
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Diverticulitis
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Intra-Abdominal Abscess
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Intra-Abdominal Infection
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Peritonitis
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Surgery
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Other surgery
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tigecycline
Treatment: Drugs - ceftriaxone plus metronidazole
Active comparator: A -
Active comparator: B -
Treatment: Drugs: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
Treatment: Drugs: ceftriaxone plus metronidazole
Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit
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Assessment method [1]
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CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.
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Timepoint [1]
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up to 6 weeks
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Secondary outcome [1]
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Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit
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Assessment method [1]
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ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.
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Timepoint [1]
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up to 6 weeks
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Secondary outcome [2]
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Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit
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Assessment method [2]
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Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.
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Timepoint [2]
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up to 6 weeks
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Secondary outcome [3]
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Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure
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Assessment method [3]
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Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization
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Timepoint [3]
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up to 6 weeks
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Eligibility
Key inclusion criteria
* Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
* Fever plus other symptoms such as nausea, vomiting, abdominal pain.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Cancer
* Medicines that suppress the immune system
* Dialysis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2008
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Sample size
Target
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Accrual to date
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Final
473
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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- Nambour
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Recruitment hospital [2]
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- Cairns
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Recruitment hospital [3]
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- Parkville
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Recruitment postcode(s) [1]
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4560 - Nambour
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Recruitment postcode(s) [2]
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QLD 4870 - Cairns
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Recruitment postcode(s) [3]
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VIC 3050 - Parkville
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Recruitment outside Australia
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China
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Shanghai
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Denmark
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Odense
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Finland
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Lahti
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Finland
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Seinajoki
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Finland
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Tampere
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France
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Marseille
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France
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Nimes
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France
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Pierre Benite
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France
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Saint Denis
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Luebeck
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Germany
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Lucknow
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Riyadh
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Bellville
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Ankara
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Turkey
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Istanbul
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United Kingdom
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Cheshire
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United Kingdom
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Birmingham
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United Kingdom
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Wigan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Wyeth is now a wholly owned subsidiary of Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
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Trial website
https://clinicaltrials.gov/study/NCT00230971
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Trial related presentations / publications
Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22.
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Wyeth is now a wholly owned subsidiary of Pfizer
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00230971
Download to PDF