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.

PHASE3CompletedINTERVENTIONAL
Enrollment

1,061

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Bacterial InfectionsDiabetic FootOsteomyelitis
Interventions
DRUG

Tigecycline

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

DRUG

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).

Trial Locations (211)

84

Pretoria

133

Rome

907

Panama City

1001

Riga

1002

Riga

1038

Riga

1070

Brussels

1072

La Plata

Morón

1076

Budapest

1080

Brussels

1082

Budapest

1090

Brussels

1100

Vienna

1180

Buenos Aires

1181

Buenos Aires

1330

Adana

1428

Buenos Aires

1501

Benoni

1657

Loma Hermosa

1702

Ciudadela, 3 de Febrero

1722

Merlo

1900

La Plata

2000

Rosario

2125

Kiev

2143

Kistarcsa

2175

Kyiv

2400

Copenhagen

2880

Bornem

3050

Melbourne

3100

Paraná

3128

Melbourne

3212

Pellenberg

3401

Liepāja

4000

San Miguel de Tucumán

4012

Debrecen

5000

Córdoba

Odense

5004

Córdoba

5016

Córdoba

5500

Mendoza

5560

Tunuyán

6014

Port Elizabeth

6620

Chivilcoy

7198

Palma de Mallorca

7602

Mar del Plata

8000

Székesfehérvár

8907

Barcelona

9024

Győr

9401

Nové Zámky

10000

Zagreb

10207

Vilnius

11527

Holargos, Athens

13419

Tallinn

18009

Cherkassy

18012

Granada

19610

West Reading

20475

Bucharest

20520

Turku

21010

Vinnytsia

21224

Baltimore

27103

Winston-Salem

28007

Madrid

28905

Getafe Madrid

29203

Columbia

30322

Kohtla-Järve

32501

Pensacola

32801

Orlando

32806

Orlando

33407

West Palm Beach

34000

Durango

34303

Istanbul

34390

Capa-Istanbul

35031

Abano Terme (PD)

35144

Panevezys

35392

Giessen

43614

Toledo

44260

Guadalajara

44280

Colonia El Ritiro

44789

Bochum

45801

Lima

45891

Gelsenkirchen

47144

Kaunas

48129

Münster

48431

Rheine

49001

Dnipro

50009

Kaunas

50410

Tartu

51014

Tartu

56124

Pisa

59200

Tourcoing

60064

North Chicago

60201

Evanston

60637

Chicago

62701

Springfield

62791

Springfield

67000

Strasbourg

69600

Zaporizhzhya

70210

Kuopio

75203

Dallas

76231

Šiauliai

78210

San Luis Potosí City

78229

San Antonio

79010

Lviv

83190

Hermosillo

90010

Los Angeles

90502

Torrance

91326

Northridge

91342

Los Angeles

Sylmar

91910

Veracruz

92288

Klaipėda

94115

San Francisco

96814

Honolulu

97517

Banska.Bysterica

100101

Beijing

100730

Beijing

111020

Moscow

113152

Moscow

127299

Moscow

127486

Moscow

129110

Moscow

129327

Moscow

150086

Harbin

196247

Saint Petersburg

198095

Saint Petersburg

214019

Smolensk

300070

Tianjin

302001

Jaipur

390001

Vadodara

400006

Cluj-Napoca

411001

Pune

510120

Guangzhou

560002

Bangalore

600114

Bacau

603005

Nizhny Novgorod

603076

Nizhny Novgorod

620109

Yekaterinburg

630117

Novosibirsk

644021

Omsk

650061

Kemerovo

700111

Lasi

02215

Boston

08244

Somers Point

CP 1428

Buenos Aires

CP 1702

Ciudadela, 3 de Febrero

CP 1900

La Plata

CP 1657

Loma Hermosa

CP 3100

Paraná

CP C1180 AAX

Buenos Aires

CP 5000

Córdoba

CP 5016

Córdoba

20211-340

Rio de Janeiro

05422-970

São Paulo

V6Z 1Y6

Vancouver

R3A 1R9

Winnipeg

L8V 1C3

Hamilton

K1H 8L6

Ottawa

G7H 5H6

Chicoutimi

H3T 1E2

Montreal

J1H 5N4

Sherbrooke

G8Z 3R9

Trois-Rivières

Unknown

Santiago

Valdivia

Bogotá

Yaroslavl

Tainan City

Taoyuan Hsien

NAP

Bogotá

23 000

Zadar

10 000

Zagreb

106 76

Athens

265 04

Rio-Patras

H-1027

Budapest

LV-1001

Riga

LV-1038

Riga

LT-50009

Kaunas

LT-10207

Vilnius

CP 5500

Mendoza

CP 2000

Santa Fe

CP 78210

San Luis Potosí City

Lima 11

Lima

Lima 31

Lima

43-300

Bielsko-Biala

43-400

Cieszyn

80-211

Gdansk

91-425

Lodz

02-097

Warsaw

50-326

Wroclaw

1169-050

Lisbon

1495-005

Lisbon

454 021

Chelyabinsk

975 17

Banská Bystrica

813 69

Bratislava

034 91

Ľubochňa

036 59

Martin

949 01

Nitra

425-801

Gyeonggi-do

135-710

Seoul

136-075

Seoul

138-736

Seoul

141 86

Huddinge

751 85

Uppsala

CH 4031

Basel

CH 1211

Geneva

02175

Kyiv

ML2 0DP

Wishaw

B29 6JD

Birmingham

B95SS

Birmingham

SE5 9RS

London

OX3 7LD

Oxford

All Listed Sponsors
lead

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

NCT00366249 - 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. | Biotech Hunter | Biotech Hunter