Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

PHASE4CompletedINTERVENTIONAL
Enrollment

550

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Skin Diseases, Bacterial
Interventions
DRUG

Tigecycline

Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)

DRUG

ampicillin-sulbactam

"Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.~A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued."

Trial Locations (57)

220

Taipei

1000

Manila

1014

Manila

1050

Mpumalanga

3610

KZ-Natal

7531

Cape Town

10330

Bangkok

10400

Bangkok

10700

Bangkok

10990

Pulau Pinang

11040

New Hyde Park

14215

Buffalo

14905

Elmira

19140

Philadelphia

19446

Lansdale

20017

Washington D.C.

20037

Washington D.C.

30905

Fort Gordon

32803

Orlando

32960

Vero Beach

43214

Columbus

45801

Lima

48202

Detroit

52621

Ramat Gan

60540

Naperville

62526

Decatur

62702

Springfield

66606

Topeka

68510

Lincoln

72401

Jonesboro

76104

Fort Worth

77026

Houston

80218

Denver

83404

Idaho Falls

85251

Scottsdale

91911

Chula Vista

91950

National City

92691

Mission Viejo

169608

Singapore

02139

Cambridge

01655

Worcester

07601

Hackensack

07754

Neptune City

R3A 1R9

Winnipeg

G7H 5H6

Chicoutimi

H1T 2M4

Montreal

G1V 4G5

Québec

J1H 5N4

Sherbrooke

G8Z 3R9

Trois-Rivières

S7N 0W8

Saskatoon

Unknown

Hong Kong

110 32090

Beirut

0181

Gauteng

301-721

Daejeon

405-760

Incheon

120-752

Seoul

133-791

Seoul

All Listed Sponsors
lead

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

NCT00368537 - Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections | Biotech Hunter | Biotech Hunter