Post-Authorization Study Evaluating Safety Of Tigecycline

NCT00827541 | Completed Results

• 2 other identifiers: B18110483074A1-4401
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and patients' conditions, in order to assess the "real incidence" of adverse events related with tigecycline in these patients.

Conditions

Intra-Abdominal Infections; Skin Disease, Infectious; Soft Tissues Infections

Keywords

tigecycline; complicated intra-abdominal infections (cIAI); complicated skin and soft tissue infections (cSSTI).

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Up to Week 12

Secondary Outcomes (3)

• Percentage of Participants With Clinical Response of Cure

  Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment

• Number of Participants With Susceptible Microbiological Pathogens

  Baseline and Week 12

• Number of Participants With Eradication of Microbiological Pathogens

  Week 12

Study Arms (1)

1

Patients hospitalized because of cIAI or cSSTI

Drug: Tigecycline

Interventions

Tigecycline DRUG

Tigecycline 50 or 100 mg intravenously. Therapy conducted according to the package leaflet of Tygacil and to international treatment guidelines. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment.

Also known as: Tygacil

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients hospitalized because of complicated intra-abdominal infections (cIAI) or complicated skin and soft tissue infections (cSSTI), in the usual health care setting

You may qualify if:

• Informed consent signed by patients prior to this study entry.
• years of age or older at the screening visit.
• Patients with cIAI or cSSTI.
• Patients who are going to or have just been given in the previous 48 hours at least a dose of tigecycline to treat any of the above infections.
• In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol.

You may not qualify if:

• Known hypersensibility to tigecycline.
• Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
• Use any investigational drug within four weeks of the screening visit.
• Uncooperative patients or a history of poor compliance.

Sponsors & Collaborators

• Pfizer: lead

Related Publications (3)

• Bassetti M, Eckmann C, Bodmann KF, Dupont H, Heizmann WR, Montravers P, Guirao X, Capparella MR, Simoneau D, Sanchez Garcia M. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140.

  PMID: 23772047 DERIVED

• Guirao X, Sanchez Garcia M, Bassetti M, Bodmann KF, Dupont H, Montravers P, Heizmann WR, Capparella MR, Simoneau D, Eckmann C. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii37-44. doi: 10.1093/jac/dkt143.

  PMID: 23772045 DERIVED

• Montravers P, Bassetti M, Dupont H, Eckmann C, Heizmann WR, Guirao X, Garcia MS, Capparella MR, Simoneau D, Bodmann KF. Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141.

  PMID: 23772042 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Intraabdominal Infections; Skin Diseases, Infectious; Soft Tissue Infections

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: August 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 1, 2012
• Results First Posted: February 1, 2012

Record last verified: 2011-12