Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

PHASE2TerminatedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Pneumonia, Bacterial
Interventions
DRUG

tigecycline

An initial intravenous (IV) loading dose of 150 mg of tigecycline, followed by 75 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin placebo given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

DRUG

tigecycline

An initial intravenous (IV) loading dose of 200 mg of tigecycline, followed by 100 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin placebo given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

DRUG

imipenem/cilastatin

Imipenem/cilastatin 1g intravenous (IV) will be administered approximately every 8 hours, for up to 14 consecutive days. In addition vancomycin 15 mg/kg IV approximately every 12 hours (q12h), an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and ceftazidime placebo will be given at the start of therapy (unless it is known at baseline that the subject does not have Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus \[MRSA\]).

Trial Locations (40)

100

Pfizer Investigational Site, Taipei

Pfizer Investigational Site, Taipei TOC

407

Pfizer Investigational Site, Tainan City

1001

Pfizer Investigational Site, Riga

1900

Pfizer Investigational Site, La Plata

2600

Pfizer Investigational Site, Vác

3128

Pfizer Investigational Site, Victoria

4043

Pfizer Investigational Site, Debrecen

4400

Pfizer Investigational Site, Nyíregyháza

4560

Pfizer Investigational Site, Nambour

8000

Pfizer Investigational Site, Székesfehérvár

10000

Pfizer Investigational Site, Zagreb

26506

Pfizer Investigational Site, Morgantown

68131

Pfizer Investigational Site, Omaha

95100

Pfizer Investigational Site, Argenteuil

119620

Pfizer Investigational Site, Moscow

121359

Pfizer Investigational Site, Moscow

188640

Pfizer Investigational Site, Vsevolozhsk

194354

Pfizer Investigational Site, Saint Petersburg

196247

Pfizer Investigational Site, Saint Petersburg

630051

Pfizer Investigational Site, Novosibirsk

Unknown

Pfizer Investigational Site, Louisville

Pfizer Investigational Site, Godoy Cruz

Pfizer Investigational Site, Provincia de Buenos Aires

Pfizer Investigational Site, Santiago

Pfizer Investigational Site, Medellín

Pfizer Investigational Site, Bogotá

Pfizer Investigational Site, Tainan City

B1900AVG

Pfizer Investigational Site, La Plata

30150-221

Pfizer Investigational Site, Belo Horizonte

90610-000

Pfizer Investigational Site, Porto Alegre

15090-000

Pfizer Investigational Site, São José do Rio Preto

G7H 5H6

Pfizer Investigational Site, Chicoutimi

G8Z 3R9

Pfizer Investigational Site, Trois-Rivières

LV-5417

Pfizer Investigational Site, Daugavpils

LV-1001

Pfizer Investigational Site, Riga

135 710

Pfizer Investigational Site, Seoul

136-705

Pfizer Investigational Site, Seoul

138-736

Pfizer Investigational Site, Seoul

152-703

Pfizer Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY