Intra-Abdominal InfectionsTIGERNCT01789905
Tygacil Drug Use Investigation
An observational study of Intra-Abdominal Infections and Skin Disease, Infectious, run by Pfizer.
Trial summary
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intra-Abdominal Infections, Skin Disease, Infectious
- What is being tested?
- Tigecycline (Tygacil)
- Type of treatment
- Injection or infusion
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2013to 16 Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving B1811187 prescribes the tigecycline (Tygacil).
Who may be able to join
- All patients who are prescribed tigecycline (Tygacil).
Who cannot join
- Subject who have not been prescribed tigecycline (Tygacil).
About this study
Official title: Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
- Being tested
- Tigecycline (Tygacil)
- Keywords
- Tygacil, Tigecycline, Post marketing surveillance, Japanese, Infection
- Medical subject headings
- Intraabdominal Infections, Skin Diseases, Infectious, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tigecycline (Tygacil)Drug
Also called Tygacil, Tigecycline
Tigecycline 50 mg intravenously. Therapy conducted according to Japanese LPD of Tygacil. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Tigecycline (Tygacil) | Subjects who are treated with tigecycline Receives: Drug: Tigecycline (Tygacil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Drug Reaction (ADR)
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician.
Measured: Up until 14 days from the start date and 28 days from the end of the observation period
Secondary outcomes (2)
Clinical Response Rate
Clinical response rate, which was defined as the percentage of participants who achieved clinical response as "effective" over the total number of assessable effectiveness analysis population("effective" plus "ineffective",) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as "effective," "ineffective," or "indeterminate" by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings.
Measured: Within 14 days from the start date
Clinical Response Rate of Cure
The cure rate, which was defined as the percentage of participants who were assessed as "cure" over the total number of assessable effectiveness analysis population ("cure" plus "failure"), was presented along with two-sided 95% CI. Clinical response of cure was assessed as "cure," "failure," or "indeterminate" by the physician within 28 days post-treatment.
Measured: Within 28 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study start15 Apr 2013
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
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.
- Other trials for Intra-Abdominal InfectionsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789905
- Sponsor's protocol ID
- B1811187
- Acronym
- TIGER
- Status last verified
- Jan 2019
- First submitted
- 8 Feb 2013
- Last updated
- 6 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)
- ClinicalTrials.gov ID
- NCT01789905
- Acronym / sponsor ID
- TIGER / B1811187
- Keywords
- Tygacil, Tigecycline, Post marketing surveillance, Japanese, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2013 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Posted 24 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tigecycline (Tygacil) | – | Drug: Tigecycline (Tygacil)Subjects who are treated with tigecycline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving B1811187 prescribes the tigecycline (Tygacil).
Key inclusion criteria (1 listed)
- All patients who are prescribed tigecycline (Tygacil).
Key exclusion criteria (1 listed)
- Subject who have not been prescribed tigecycline (Tygacil).
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 |
|---|---|---|
| Tigecycline (Tygacil)Also: Tygacil, TigecyclineTigecycline 50 mg intravenously. Therapy conducted according to Japanese LPD of Tygacil. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment. | Drug | Tigecycline (Tygacil) |
Primary outcome
Number of Participants With Adverse Drug Reaction (ADR)
Time frame: Up until 14 days from the start date and 28 days from the end of the observation period
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician.
2 secondary outcomes
Clinical Response Rate
Time frame: Within 14 days from the start date
Clinical Response Rate of Cure
Time frame: Within 28 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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 Intra-Abdominal Infections and Skin Disease, Infectious, 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 1 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 6 Feb 2019. 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 24 Dec 2018). 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?
Number of Participants With Adverse Drug Reaction (ADR) (time frame: Up until 14 days from the start date and 28 days from the end of the observation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2019.