A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
A Non-Interventional Study To Evaluate The Safety And Effectiveness Of Tygacil In The Treatment Of Patients With Complicated Intra-Abdominal Infections Or Complicated Skin And Skin Structure Infections
2 other identifiers
observational
1,028
0 countries
N/A
Brief Summary
To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (Safety of Tygacil); to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against Tygacil in Germany; to determine which antibiotic agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic substance non-responders to Tygacil are switched; to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil; to collect information on profile, comorbidities and characteristics of patients treated with Tygacil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2006
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 18, 2007
CompletedFirst Posted
Study publicly available on registry
June 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
July 18, 2011
CompletedJuly 22, 2011
June 1, 2011
3.3 years
June 18, 2007
March 29, 2011
July 20, 2011
Conditions
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Clinical and Microbiological Cure: All Participants
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
Percentage of Participants With Composite Cure: All Participants
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Percentage of Participants With Composite Cure: Nosocomial Infections
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Percentage of Participants With Composite Cure: Community-acquired Infections
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
Secondary Outcomes (6)
Participants With Probable Failure at Follow-up
Follow-up (up to Day 47)
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Follow-up (up to Day 47)
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
Baseline to End of Treatment (up to Day 47)
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Baseline to End of Treatment (up to Day 47)
Reasons for Utilization of Tygacil
Baseline to End of Treatment (up to Day 47)
- +1 more secondary outcomes
Study Arms (1)
A
Interventions
The patients will be treated in accordance with the requirements of the labeling of tigecycline in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Eligibility Criteria
Adult patients (i.e., at least 18 years old) with a verified diagnosis of complicated Intra-Abdominal Infection (cIAI) or complicated Skin and Skin Structure Infection (cSSSI), for whom the decision for Tygacil treatment had already been made.
You may qualify if:
- Actual or planned therapy with tigecycline.
- At least 18 years old.
You may not qualify if:
- Hypersensitivity to antibiotics or tigecycline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
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: 23772047DERIVEDGuirao 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: 23772045DERIVEDMontravers 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: 23772042DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
Study Record Dates
First Submitted
June 18, 2007
First Posted
June 20, 2007
Study Start
November 1, 2006
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
July 22, 2011
Results First Posted
July 18, 2011
Record last verified: 2011-06