Clinical trial NCT00488488: A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 1028
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Eligibility criteria: Inclusion Criteria:

* Actual or planned therapy with tigecycline.
* At least 18 years old.

Exclusion Criteria:

* Hypersensitivity to antibiotics or tigecycline.

Primary outcomes:
measure: Percentage of Participants With Clinical and Microbiological Cure: All Participants
timeFrame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
measure: Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections
timeFrame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
measure: Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections
timeFrame: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
measure: Percentage of Participants With Composite Cure: All Participants
timeFrame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
measure: Percentage of Participants With Composite Cure: Nosocomial Infections
timeFrame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
measure: Percentage of Participants With Composite Cure: Community-acquired Infections
timeFrame: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
Secondary outcomes:
measure: Participants With Probable Failure at Follow-up
timeFrame: Follow-up (up to Day 47)
measure: Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
timeFrame: Follow-up (up to Day 47)
measure: Antibiotic Agents Chosen for Combination Therapy With Tigecycline
timeFrame: Baseline to End of Treatment (up to Day 47)
measure: Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
timeFrame: Baseline to End of Treatment (up to Day 47)
measure: Reasons for Utilization of Tygacil
timeFrame: Baseline to End of Treatment (up to Day 47)
measure: Overall Mortality: All Participants
timeFrame: Baseline to End of Treatment (up to Day 47)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.