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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00366249
Date of registration:	17/08/2006
Prospective Registration:	Yes
Primary sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
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.
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
Date of first enrolment:	January 2007
Target sample size:	1061
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00366249
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Argentina	Australia	Austria	Belgium	Brazil	Canada	Chile	China
Colombia	Croatia	Denmark	Estonia	Finland	France	Germany	Greece
Hungary	India	Italy	Korea, Republic of	Latvia	Lithuania	Mexico	Panama
Peru	Poland	Portugal	Romania	Russian Federation	Slovakia	South Africa	Spain
Sweden	Switzerland	Taiwan	Turkey	Ukraine	United Kingdom	United States

Contacts

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Estonia, WVPMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Greece, decresg@wyeth.com

Name:	Trial Manager
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Affiliation:	For Russia, WVPIMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Spain, infomed@wyeth.com

Name:	Trial Manager
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Affiliation:	For Denmark, medinfonord@wyeth.com

Name:	Trial Manager
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Affiliation:	For Romania, WVPIMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Sweden, MedInfoNord@wyeth.com

Name:	Trial Manager
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Affiliation:	For Turkey, Erisc@wyeth.com

Name:	Trial Manager
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Affiliation:	For Australia, medinfo@wyeth.com

Name:	Trial Manager
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Affiliation:	For Austria, WPVIMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Belgium, trials-BEL@wyeth.com

Name:	Trial Manager
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Affiliation:	For Chile, scheima@wyeth.com

Name:	Trial Manager
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Affiliation:	For Latvia, WPVIMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com

Name:	Trial Manager
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Affiliation:	For UK/Great Britian: ukmedinfo@wyeth.com

Name:	Trial Manager
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Affiliation:	For Argentina, Scheima@wyeth.com

Name:	Trial Manager
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Affiliation:	For China, medinfo@wyeth.com

Name:	Trial Manager
Address:
Telephone:
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Affiliation:	For Finland, MedInfoNord@wyeth.com

Name:	Trial Manager
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Affiliation:	For Germany, medinfoDEU@wyeth.com

Name:	Trial Manager
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Affiliation:	For Lithuania, WPVIMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Taiwan, medinfo@wyeth.com

Name:	Medical Monitor
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Affiliation:	Wyeth is now a wholly owned subsidiary of Pfizer

Name:	Trial Manager
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Affiliation:	For France, infomedfrance@wyeth.com

Name:	Trial Manager
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Affiliation:	For Italy, descresg@wyeth.com

Name:	Trial Manager
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Affiliation:	For South Africa, ZAFinfo@wyeth.com

Name:	Trial Manager
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Affiliation:	For Switzerland, med@wyeth.com

Name:	Trial Manager
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Affiliation:	For Brazil, xavierl@wyeth.com

Name:	Trial Manager
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Affiliation:	For Canada, clintrialparticipation@wyeth.com

Name:	Trial Manager
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Affiliation:	For Croatia, WPBUMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Mexico, gomezzlj@wyeth.com

Name:	Trial Manager
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Affiliation:	For Ukraine, WVPIMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Hungary, WPBUMED@wyeth.com

Name:	Trial Manager
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Affiliation:	For Poland, WPWZMED@wyeth.com

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetic Foot

Osteomyelitis

Bacterial Infections

Intervention(s)

Drug: Ertapenem

Drug: Tigecycline

Primary Outcome(s)

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate. [Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose]

Number of Patients With Clinical Response of Cure Vs. Failure. [Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose]

Secondary Outcome(s)

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose. [Time Frame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose]

Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose. [Time Frame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose]

Number of Patients With Microbiologic Response of Eradication. [Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose]

Secondary ID(s)

3074K5-319

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	21/08/2009
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00366249

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