N/A
N=1,028
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
Infection
Bottom Line
View on ClinicalTrials.gov: NCT00488488 ↗Enrolled (actual)
1,028
Serious AEs
23.9%
Results posted
Jul 2011
Primary outcome: Primary: Percentage of Participants With Clinical and Microbiological Cure: All Participants — 33.8 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- tigecycline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical and Microbiological Cure: All Participants |
33.8 | — |
| PRIMARY Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections |
29.0 | — |
| PRIMARY Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections |
43.9 | — |
| PRIMARY Percentage of Participants With Composite Cure: All Participants |
74.2 | — |
| PRIMARY Percentage of Participants With Composite Cure: Nosocomial Infections |
70.5 | — |
| PRIMARY Percentage of Participants With Composite Cure: Community-acquired Infections |
82.3 | — |
| SECONDARY Participants With Probable Failure at Follow-up |
162 | — |
| SECONDARY Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure |
100.0; 100.0; 100.0; 50.0; 50.0; 25.0 | — |
| SECONDARY Antibiotic Agents Chosen for Combination Therapy With Tigecycline |
18.6; 6.0; 5.8; 4.8; 4.7; 2.6 | — |
| SECONDARY Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic |
7.8; 6.9; 2.5; 1.4; 0.5 | — |
| SECONDARY Reasons for Utilization of Tygacil |
53.6; 45.9; 45.2; 11.1; 2.0 | — |
| SECONDARY Overall Mortality: All Participants |
20.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Actual or planned therapy with tigecycline.
- At least 18 years old.
Exclusion Criteria
- Hypersensitivity to antibiotics or tigecycline.
Data sourced from ClinicalTrials.gov (NCT00488488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.