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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 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.

Phase 3
Completed
Conditions
Bacterial Infections
Diabetic Foot
Osteomyelitis
Interventions
First Posted Date
2006-08-21
Last Posted Date
2010-04-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
1061
Registration Number
NCT00366249

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

Phase 4
Completed
Conditions
Appendicitis
Cholecystitis
Diverticulitis
Intra-Abdominal Abscess
Intra-Abdominal Infection
Peritonitis
Interventions
First Posted Date
2005-10-03
Last Posted Date
2013-02-25
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
473
Registration Number
NCT00230971

Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections

Phase 3
Completed
Conditions
Skin Diseases, Infectious
First Posted Date
2005-09-28
Last Posted Date
2013-02-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
503
Registration Number
NCT00228410

Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.

Phase 3
Completed
Conditions
Bacterial Infections
First Posted Date
2005-09-20
Last Posted Date
2013-02-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
26
Registration Number
NCT00205816

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

Phase 4
Completed
Conditions
Appendicitis
Cholecystitis
Cross Infection
Diverticulitis
Peritonitis
Interventions
First Posted Date
2005-09-19
Last Posted Date
2013-02-25
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
467
Registration Number
NCT00195351

Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections

Phase 3
Completed
Conditions
Abdominal Abscess
Interventions
First Posted Date
2005-08-26
Last Posted Date
2009-07-07
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
200
Registration Number
NCT00136201

Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

Phase 3
Completed
Conditions
Gram-Positive Bacterial Infections
Cross Infection
First Posted Date
2004-04-21
Last Posted Date
2013-02-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
850
Registration Number
NCT00081744

Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

Phase 3
Completed
Conditions
Community-Acquired Infections
Bacterial Pneumonia
Cross Infection
First Posted Date
2004-04-19
Last Posted Date
2013-02-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
434
Registration Number
NCT00081575

Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia

Phase 3
Completed
Conditions
Bacterial Pneumonia
First Posted Date
2004-04-07
Last Posted Date
2008-08-04
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
430
Registration Number
NCT00080496

Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms

Phase 3
Completed
Conditions
Gram-Negative Bacterial Infections
First Posted Date
2004-03-23
Last Posted Date
2013-02-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
115
Registration Number
NCT00079989
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