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.

Diabetic Foot Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366249
• Other study ID #: 3074K5-319
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2006
• Last updated: April 22, 2010
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Human Research Ethics CommitteeBrazil: Ministry of HealthCanada: Health CanadaChile: Instituto de Salud Pública de ChileChina: Ministry of HealthEuropean Union: European Medicines AgencyHong Kong: Department of HealthIndia: Ministry of HealthKorea: Food and Drug AdministrationMexico: Ethics CommitteePeru: General Directorate of Pharmaceuticals, Devices, and DrugsSingapore: Health Sciences AuthoritySouth Africa: Medicines Control CouncilTaiwan: Department of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1061
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Diabetic Foot
• Infection
• Osteomyelitis

Intervention

Drug:
• Tigecycline
150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Clinical Response of Cure Vs. Failure.	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.	Test of cure visit (TOC): Assessed at least 12 days post last dose	No
Primary	Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.	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.	Test of cure visit (TOC): Assessed at least 12 days post last dose	No
Secondary	Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.	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.	Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose	No
Secondary	Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.	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.	Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose	No
Secondary	Number of Patients With Microbiologic Response of Eradication.	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.	Test of cure visit (TOC): Assessed at least 12 days post last dose	No