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.

NCT00366249 | Completed Phase 3 Results DMC

• 1 other identifier: 3074K5-319
• Study Type: interventional
• Target: 1,061
• Locations: 37 countries
• Sites: 206

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.

Conditions

Bacterial Infections; Diabetic Foot; Osteomyelitis

Keywords

Diabetic foot infection; Osteomyelitis; Diabetes Complications; Foot ulcer; Skin infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.

  Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

• Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.

  Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

• Number of Patients With Microbiologic Response of Eradication.

  Test of cure visit (TOC): Assessed at least 12 days post last dose

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Tigecycline

B

ACTIVE COMPARATOR

Drug: Ertapenem

Interventions

Tigecycline DRUG

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

A

Ertapenem DRUG

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).

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• People with additional significant disease, infection with resistant pathogens, contraindication, or hypersensitivity to any test article or related antibiotic.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (211)

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Los Angeles, California, 90010, United States

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Los Angeles, California, 91342, United States

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Northridge, California, 91326, United States

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San Francisco, California, 94115, United States

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Sylmar, California, 91342, United States

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Torrance, California, 90502, United States

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Orlando, Florida, 32801, United States

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Orlando, Florida, 32806, United States

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Pensacola, Florida, 32501, United States

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West Palm Beach, Florida, 33407, United States

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Honolulu, Hawaii, 96814, United States

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Chicago, Illinois, 60637, United States

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Evanston, Illinois, 60201, United States

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North Chicago, Illinois, 60064, United States

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Springfield, Illinois, 62701, United States

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Springfield, Illinois, 62791, United States

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Baltimore, Maryland, 21224, United States

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Boston, Massachusetts, 02215, United States

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Somers Point, New Jersey, 08244, United States

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Winston-Salem, North Carolina, 27103, United States

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Lima, Ohio, 45801, United States

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Toledo, Ohio, 43614, United States

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West Reading, Pennsylvania, 19610, United States

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Columbia, South Carolina, 29203, United States

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Dallas, Texas, 75203, United States

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San Antonio, Texas, 78229, United States

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Buenos Aires, Buenos Aires, CP 1428, Argentina

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Chivilcoy, Buenos Aires, 6620, Argentina

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Ciudadela, 3 de Febrero, Buenos Aires, 1702, Argentina

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Ciudadela, 3 de Febrero, Buenos Aires, CP 1702, Argentina

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La Plata, Buenos Aires, 1072, Argentina

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La Plata, Buenos Aires, 1900, Argentina

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La Plata, Buenos Aires, CP 1900, Argentina

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Loma Hermosa, Buenos Aires, 1657, Argentina

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Loma Hermosa, Buenos Aires, CP 1657, Argentina

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Mar del Plata, Buenos Aires, 7602, Argentina

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Merlo, Buenos Aires, 1722, Argentina

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Morón, Buenos Aires, 1072, Argentina

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Paraná, Entre Ríos Province, 3100, Argentina

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Paraná, Entre Ríos Province, CP 3100, Argentina

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Tunuyán, Mendoza Province, 5560, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Buenos Aires, 1180, Argentina

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Buenos Aires, 1181, Argentina

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Buenos Aires, 1428, Argentina

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Buenos Aires, CP C1180 AAX, Argentina

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Córdoba, 5000, Argentina

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Córdoba, 5004, Argentina

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Córdoba, 5016, Argentina

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Córdoba, CP 5000, Argentina

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Córdoba, CP 5016, Argentina

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Mendoza, 5500, Argentina

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Melbourne, Victoria, 3050, Australia

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Melbourne, Victoria, 3128, Australia

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Vienna, 1100, Austria

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Bornem, 2880, Belgium

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Brussels, 1070, Belgium

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Brussels, 1080, Belgium

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Brussels, 1090, Belgium

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Pellenberg, 3212, Belgium

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Rio de Janeiro, 20211-340, Brazil

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São Paulo, 05422-970, Brazil

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Hamilton, Ontario, L8V 1C3, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Trois-Rivières, Quebec, G8Z 3R9, Canada

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Santiago, Chile

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Valdivia, Chile

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Harbin, Heilongjiang, 150086, China

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Beijing, 100101, China

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Beijing, 100730, China

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Guangzhou, 510120, China

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Tianjin, 300070, China

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Bogotá, NAP, Colombia

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Bogotá, Colombia

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Zadar, 23 000, Croatia

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Zagreb, 10 000, Croatia

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Zagreb, 10000, Croatia

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Odense, 5000, Denmark

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Kohtla-Järve, Ida-Virumaa, 30322, Estonia

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Tallinn, 13419, Estonia

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Tartu, 50410, Estonia

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Tartu, 51014, Estonia

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Kuopio, 70210, Finland

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Turku, 20520, Finland

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Strasbourg, 67000, France

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Tourcoing, 59200, France

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Giessen, Hesse, 35392, Germany

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Bochum, North Rhine-Westphalia, 44789, Germany

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Gelsenkirchen, North Rhine-Westphalia, 45891, Germany

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Rheine, North Rhine-Westphalia, 48431, Germany

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Münster, Northrhien-Westphalia, 48129, Germany

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Athens, 106 76, Greece

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Holargos, Athens, 11527, Greece

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Rio-Patras, 265 04, Greece

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Budapest, 1076, Hungary

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Budapest, 1082, Hungary

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Budapest, H-1027, Hungary

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Debrecen, 4012, Hungary

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Győr, 9024, Hungary

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Kistarcsa, 2143, Hungary

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Székesfehérvár, 8000, Hungary

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Vadodara, Gujarat, 390001, India

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Bangalore, Karnataka, 560002, India

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Pune, Maharashtra, 411001, India

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Jaipur, Rajasthan, 302001, India

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Abano Terme (PD), 35031, Italy

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Pisa, 56124, Italy

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Rome, 133, Italy

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Liepāja, 3401, Latvia

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Riga, 1001, Latvia

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Riga, 1002, Latvia

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Riga, 1038, Latvia

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Riga, LV-1001, Latvia

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Riga, LV-1038, Latvia

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Kaunas, 47144, Lithuania

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Kaunas, 50009, Lithuania

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Kaunas, LT-50009, Lithuania

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Klaipėda, 92288, Lithuania

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Panevezys, 35144, Lithuania

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Šiauliai, 76231, Lithuania

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Vilnius, 10207, Lithuania

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Vilnius, LT-10207, Lithuania

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Colonia El Ritiro, Guadalajara, 44280, Mexico

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Guadalajara, Jalisco, 44260, Mexico

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Mendoza, Mendoza, CP 5500, Mexico

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Santa Fe, Santa Fe, CP 2000, Mexico

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Hermosillo, Sonora, 83190, Mexico

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Durango, 34000, Mexico

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San Luis Potosí City, 78210, Mexico

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San Luis Potosí City, CP 78210, Mexico

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Veracruz, 91910, Mexico

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Panama City, 907, Panama

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Lima, Lima 11, Peru

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Lima, Lima 31, Peru

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Bielsko-Biala, 43-300, Poland

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Cieszyn, 43-400, Poland

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Gdansk, 80-211, Poland

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Lodz, 91-425, Poland

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Warsaw, 02-097, Poland

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Wroclaw, 50-326, Poland

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Lisbon, 1169-050, Portugal

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Lisbon, 1495-005, Portugal

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Bacau, 600114, Romania

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Bucharest, 20475, Romania

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Cluj-Napoca, 400006, Romania

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Lasi, 700111, Romania

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Chelyabinsk, 454 021, Russia

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Kemerovo, 650061, Russia

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Moscow, 111020, Russia

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Moscow, 113152, Russia

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Moscow, 127299, Russia

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Moscow, 127486, Russia

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Moscow, 129110, Russia

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Moscow, 129327, Russia

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Nizhny Novgorod, 603005, Russia

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Nizhny Novgorod, 603076, Russia

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Novosibirsk, 630117, Russia

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Omsk, 644021, Russia

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Saint Petersburg, 196247, Russia

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Saint Petersburg, 198095, Russia

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Smolensk, 214019, Russia

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Yaroslavl, Russia

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Yekaterinburg, 620109, Russia

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Banska.Bysterica, 97517, Slovakia

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Banská Bystrica, 975 17, Slovakia

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Bratislava, 813 69, Slovakia

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Ľubochňa, 034 91, Slovakia

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Martin, 036 59, Slovakia

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Nitra, 949 01, Slovakia

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Nové Zámky, 9401, Slovakia

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Port Elizabeth, Eastern Cape, 6014, South Africa

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Benoni, Gauteng, 1501, South Africa

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Pretoria, Gauteng, 84, South Africa

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Gyeonggi-do, 425-801, South Korea

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Seoul, 135-710, South Korea

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Seoul, 136-075, South Korea

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Seoul, 138-736, South Korea

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Barcelona, 8907, Spain

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Getafe Madrid, 28905, Spain

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Granada, 18012, Spain

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Madrid, 28007, Spain

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Palma de Mallorca, 7198, Spain

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Copenhagen, 2400, Sweden

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Huddinge, 141 86, Sweden

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Uppsala, 751 85, Sweden

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Basel, CH 4031, Switzerland

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Geneva, CH 1211, Switzerland

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Tainan, Taiwan

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Taoyuan Hsien, Taiwan

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Adana, 1330, Turkey (Türkiye)

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Capa-Istanbul, 34390, Turkey (Türkiye)

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Istanbul, 34303, Turkey (Türkiye)

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Cherkassy, 18009, Ukraine

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Dnipro, 49001, Ukraine

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Kiev, 2125, Ukraine

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Kyiv, 02175, Ukraine

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Kyiv, 2175, Ukraine

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Lviv, 79010, Ukraine

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Vinnytsia, 21010, Ukraine

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Zaporizhzhya, 69600, Ukraine

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Wishaw, Lanarkshire, ML2 0DP, United Kingdom

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Birmingham, West Midlands, B29 6JD, United Kingdom

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Birmingham, B95SS, United Kingdom

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London, SE5 9RS, United Kingdom

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Oxford, OX3 7LD, United Kingdom

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Related Publications (1)

• Lauf L, Ozsvar Z, Mitha I, Regoly-Merei J, Embil JM, Cooper A, Sabol MB, Castaing N, Dartois N, Yan J, Dukart G, Maroko R. Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis. Diagn Microbiol Infect Dis. 2014 Apr;78(4):469-80. doi: 10.1016/j.diagmicrobio.2013.12.007. Epub 2013 Dec 16.

  PMID: 24439136 DERIVED

MeSH Terms

Conditions

Bacterial Infections; Diabetic Foot; Osteomyelitis; Diabetes Complications; Foot Ulcer; Cellulitis

Interventions

Tigecycline; Ertapenem

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Foot Diseases; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbapenems; beta-Lactams; Lactams; Amides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Belgium, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Hungary, WPBUMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Spain, infomed@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Taiwan, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For South Africa, ZAFinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Canada, clintrialparticipation@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Australia, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Austria, WPVIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Croatia, WPBUMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Latvia, WPVIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Lithuania, WPVIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Romania, WVPIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Argentina, Scheima@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Brazil, xavierl@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Chile, scheima@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Mexico, gomezzlj@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Sweden, MedInfoNord@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, medinfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Denmark, medinfonord@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Estonia, WVPMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Finland, MedInfoNord@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For UK/Great Britian: ukmedinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Switzerland, med@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Greece, decresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Italy, descresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Russia, WVPIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Turkey, Erisc@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Ukraine, WVPIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For China, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 28, 2010
• Results First Posted: August 21, 2009

Record last verified: 2010-04

Locations

ES (5); PT (2); IN (4); FI (2); CO (2); AU (2); PA (1); PL (6); CH (2); TW (2); SL (7); TU (3); AR (27); LI (8); HU (7); PE (2); BR (2); RO (4); FR (2); CN (5); ME (9); RU (17); KR (4); CR (3); ZA (3); CL (2); LA (6); SE (3); UA (8); US (26); CA (8); BE (5); DK (1); GR (3); DE (5); IT (3); GB (5)