InfectionNCT00488488
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
An observational study of Infection, run by Pfizer.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- tigecycline
- How many people
- 1,028 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Mar 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Actual or planned therapy with tigecycline.
- At least 18 years old.
Who cannot join
- Hypersensitivity to antibiotics or tigecycline.
About this study
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
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.
Read the detailed description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
- Conditions
- Infection
- Being tested
- tigecycline
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tigecyclineDrug
Also called Tygacil
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: tigecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.
Measured: Follow-up (up to Day 47)
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.
Measured: Follow-up (up to Day 47)
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.
Measured: Baseline to End of Treatment (up to Day 47)
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Reasons for change in antibiotic treatment from Tygacil to another antibiotic.
Measured: Baseline to End of Treatment (up to Day 47)
Reasons for Utilization of Tygacil
Measured: Baseline to End of Treatment (up to Day 47)
Overall Mortality: All Participants
Deaths for any reasons occurring during the study observation period.
Measured: Baseline to End of Treatment (up to Day 47)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startNov 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488488
- Sponsor's protocol ID
- 3074A1-102045
- Other IDs
- B1811054
- Status last verified
- Jun 2011
- First submitted
- 18 Jun 2007
- Last updated
- 22 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23772047Guirao 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.
PubMed 23772045Montravers 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.
PubMed 23772042
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00488488
- Acronym / sponsor ID
- 3074A1-102045
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Posted 18 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: tigecycline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Actual or planned therapy with tigecycline.
- At least 18 years old.
Key exclusion criteria (1 listed)
- Hypersensitivity to antibiotics or tigecycline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tigecyclineAlso: TygacilThe 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. | Drug | A |
Primary outcome
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)
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)
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)
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)
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)
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)
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
6 secondary outcomes
Participants With Probable Failure at Follow-up
Time frame: Follow-up (up to Day 47)
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Time frame: Follow-up (up to Day 47)
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
Time frame: Baseline to End of Treatment (up to Day 47)
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Time frame: Baseline to End of Treatment (up to Day 47)
Reasons for Utilization of Tygacil
Time frame: Baseline to End of Treatment (up to Day 47)
Overall Mortality: All Participants
Time frame: Baseline to End of Treatment (up to Day 47)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23772047Bassetti 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.
- Derived from this study: PubMed 23772045Guirao 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.
- Derived from this study: PubMed 23772042Montravers 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00488488, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.