A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00488488
First received: June 18, 2007
Last updated: July 20, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Infection |
Drug: tigecycline |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Antibiotics
Drug Information available for:
Tigecycline
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants With Clinical and Microbiological Cure: All Participants [ Time Frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) ] [ Designated as safety issue: No ]Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
- Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections [ Time Frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) ] [ Designated as safety issue: No ]Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
- Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections [ Time Frame: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) ] [ Designated as safety issue: No ]Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
- Percentage of Participants With Composite Cure: All Participants [ Time Frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) ] [ Designated as safety issue: No ]Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
- Percentage of Participants With Composite Cure: Nosocomial Infections [ Time Frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) ] [ Designated as safety issue: No ]Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
- Percentage of Participants With Composite Cure: Community-acquired Infections [ Time Frame: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) ] [ Designated as safety issue: No ]Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
Secondary Outcome Measures:
- Participants With Probable Failure at Follow-up [ Time Frame: Follow-up (up to Day 47) ] [ Designated as safety issue: No ]Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.
- Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure [ Time Frame: Follow-up (up to Day 47) ] [ Designated as safety issue: No ]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.
- Antibiotic Agents Chosen for Combination Therapy With Tigecycline [ Time Frame: Baseline to End of Treatment (up to Day 47) ] [ Designated as safety issue: No ]Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.
- Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic [ Time Frame: Baseline to End of Treatment (up to Day 47) ] [ Designated as safety issue: No ]Reasons for change in antibiotic treatment from Tygacil to another antibiotic.
- Reasons for Utilization of Tygacil [ Time Frame: Baseline to End of Treatment (up to Day 47) ] [ Designated as safety issue: No ]
- Overall Mortality: All Participants [ Time Frame: Baseline to End of Treatment (up to Day 47) ] [ Designated as safety issue: No ]Deaths for any reasons occurring during the study observation period.
| Enrollment: | 1028 |
| Study Start Date: | November 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A |
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.
Other Name: Tygacil
|
Detailed Description:
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Inclusion Criteria:
- Actual or planned therapy with tigecycline.
- At least 18 years old.
Exclusion Criteria:
- Hypersensitivity to antibiotics or tigecycline.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
| ClinicalTrials.gov Identifier: | NCT00488488 History of Changes |
| Other Study ID Numbers: | 3074A1-102045, B1811054 |
| Study First Received: | June 18, 2007 |
| Results First Received: | March 29, 2011 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Tigecycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013