MedPath

Tigecycline

Generic Name
Tigecycline
Brand Names
Tygacil, Tigecycline Accord
Drug Type
Small Molecule
Chemical Formula
C29H39N5O8
CAS Number
220620-09-7
Unique Ingredient Identifier
70JE2N95KR
Background

Tigecycline is a glycylcycline antibiotic developed and marketed by Wyeth under the brand name Tygacil. It was developed in response to the growing prevalence of antibiotic resistance in bacteria such as Staphylococcus aureus. It was granted fast-track approval by the U.S. Food and Drug Administration (FDA) on June 17, 2005.

Indication

For the treatment of infections caused by susceptible strains of the designated microorganisms in the following conditions: Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes and Bacteroides fragilis. Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

Associated Conditions
Bacterial Infections, Community Acquired Pneumonia (CAP), Complicated Intra-Abdominal Infections (cIAIs), Complicated Skin and Skin Structure Infection

Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects

Phase 3
Completed
Conditions
Community-Acquired Infections
First Posted Date
2007-12-17
Last Posted Date
2011-06-03
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
9
Registration Number
NCT00575094

A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting

Completed
Conditions
Infection
Interventions
First Posted Date
2007-06-20
Last Posted Date
2011-07-22
Lead Sponsor
Pfizer
Target Recruit Count
1028
Registration Number
NCT00488488

Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age

Phase 2
Completed
Conditions
Bacterial Infections
Intra-Abdominal Infection
Pneumonia, Bacterial
Skin Diseases, Bacterial
Skin Diseases, Infectious
Interventions
First Posted Date
2007-06-20
Last Posted Date
2012-10-24
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
59
Registration Number
NCT00488345

Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

Phase 4
Completed
Conditions
Abdominal Abscess
First Posted Date
2007-06-20
Last Posted Date
2009-07-07
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
50
Registration Number
NCT00488306

Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI

Phase 4
Completed
Conditions
Skin Diseases, Infectious
First Posted Date
2007-06-20
Last Posted Date
2007-12-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
50
Registration Number
NCT00488761

Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)

Completed
Conditions
Peritonitis
First Posted Date
2007-06-04
Last Posted Date
2009-09-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
180
Registration Number
NCT00481962

Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection

Phase 4
Completed
Conditions
Staphylococcal Infections
Interventions
First Posted Date
2007-01-09
Last Posted Date
2011-06-22
Lead Sponsor
CPL Associates
Target Recruit Count
10
Registration Number
NCT00419991
Locations
🇺🇸

CPL Associates Investigational Site, Cumberland, Maryland, United States

Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Phase 1
Completed
Conditions
Liver Cirrhosis, Biliary
Interventions
First Posted Date
2006-12-04
Last Posted Date
2011-04-04
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
8
Registration Number
NCT00406237
Locations
🇵🇷

Pfizer Investigational Site, Santurce, Puerto Rico

Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Phase 1
Completed
Conditions
Healthy Subjects
First Posted Date
2006-09-14
Last Posted Date
2009-07-10
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
36
Registration Number
NCT00376324

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

Phase 4
Completed
Conditions
Skin Diseases, Bacterial
Interventions
First Posted Date
2006-08-24
Last Posted Date
2012-08-09
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
550
Registration Number
NCT00368537
© Copyright 2025. All Rights Reserved by MedPath