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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00366249
Registration number
NCT00366249
Ethics application status
Date submitted
17/08/2006
Date registered
21/08/2006
Date last updated
28/04/2010
Titles & IDs
Public title
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
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Scientific title
A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes
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Secondary ID [1]
0
0
3074K5-319
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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:
Bacterial Infections
0
0
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Diabetic Foot
0
0
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Osteomyelitis
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Studies of infection and infectious agents
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Infection
0
0
0
0
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Other infectious diseases
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Infection
0
0
0
0
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Sexually transmitted infections
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Musculoskeletal
0
0
0
0
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Other muscular and skeletal disorders
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Metabolic and Endocrine
0
0
0
0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tigecycline
Treatment: Drugs - Ertapenem
Active Comparator: A -
Active Comparator: B -
Treatment: Drugs: Tigecycline
150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
Treatment: Drugs: Ertapenem
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
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Number of Patients With Clinical Response of Cure Vs. Failure.
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Assessment method [1]
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Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.
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Timepoint [1]
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0
Test of cure visit (TOC): Assessed at least 12 days post last dose
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Primary outcome [2]
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Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.
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Assessment method [2]
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Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.
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Timepoint [2]
0
0
Test of cure visit (TOC): Assessed at least 12 days post last dose
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Secondary outcome [1]
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Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.
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Assessment method [1]
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Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.
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Timepoint [1]
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Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
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Secondary outcome [2]
0
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Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.
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Assessment method [2]
0
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Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.
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Timepoint [2]
0
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Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
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Secondary outcome [3]
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Number of Patients With Microbiologic Response of Eradication.
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Assessment method [3]
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Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.
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Timepoint [3]
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Test of cure visit (TOC): Assessed at least 12 days post last dose
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Eligibility
Key inclusion criteria
Main inclusion criteria:
- Men and women aged 18 or older with diabetes and a qualifying foot infection. People
with evidence of a diabetic foot infection with osteomyelitis may qualify for the
osteomyelitis substudy arm.
Main exclusion criteria:
- People with additional significant disease, infection with resistant pathogens,
contraindication, or hypersensitivity to any test article or related antibiotic.
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Minimum age
18
Years
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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
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/01/2007
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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
1/03/2009
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Sample size
Target
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Accrual to date
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Final
1061
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- Melbourne
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Recruitment postcode(s) [1]
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3050 - Melbourne
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Recruitment postcode(s) [2]
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3128 - Melbourne
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Recruitment outside Australia
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Adana
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Country [132]
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Turkey
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State/province [132]
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Capa-Istanbul
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Country [133]
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Turkey
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State/province [133]
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Istanbul
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Country [134]
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Ukraine
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State/province [134]
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Cherkassy
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Country [135]
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Ukraine
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State/province [135]
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Dnepropetrovsk
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Country [136]
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Ukraine
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State/province [136]
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Kiev
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Country [137]
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Ukraine
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State/province [137]
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Kyiv
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Country [138]
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Ukraine
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State/province [138]
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Lviv
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Country [139]
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Ukraine
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State/province [139]
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Vinnytsia
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Country [140]
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Ukraine
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State/province [140]
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Zaporozhye
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Country [141]
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United Kingdom
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State/province [141]
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Lanarkshire
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Country [142]
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United Kingdom
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State/province [142]
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West Midlands
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Country [143]
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United Kingdom
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State/province [143]
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Birmingham
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Country [144]
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United Kingdom
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State/province [144]
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London
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Country [145]
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United Kingdom
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State/province [145]
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Oxford
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to look at the safety and effectiveness of a once-daily dose of
tigecycline compared to ertapenem for the treatment of diabetic foot infections. The
co-primary efficacy endpoints were not met.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00366249
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Trial related presentations / publications
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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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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00366249
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