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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488488
• Other study ID #: 3074A1-102045
• Secondary ID: B1811054
• Status: Completed
• Phase: N/A
• First received: June 18, 2007
• Last updated: July 20, 2011
• Start date: November 2006
• Est. completion date: March 2010

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Description:

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1028
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Actual or planned therapy with tigecycline.

• At least 18 years old.

Exclusion Criteria:

• Hypersensitivity to antibiotics or tigecycline.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• tigecycline
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Participants With Probable Failure at Follow-up	Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.	Follow-up (up to Day 47)	No
Secondary	Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure	Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.	Follow-up (up to Day 47)	No
Secondary	Antibiotic Agents Chosen for Combination Therapy With Tigecycline	Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.	Baseline to End of Treatment (up to Day 47)	No
Secondary	Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic	Reasons for change in antibiotic treatment from Tygacil to another antibiotic.	Baseline to End of Treatment (up to Day 47)	No
Secondary	Reasons for Utilization of Tygacil		Baseline to End of Treatment (up to Day 47)	No
Secondary	Overall Mortality: All Participants	Deaths for any reasons occurring during the study observation period.	Baseline to End of Treatment (up to Day 47)	No

External Links

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