Complicated Skin and Skin Structure InfectionsNCT00683332
Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)
An observational study of Complicated Skin and Skin Structure Infections and Complicated Intra-abdominal Infections, run by Pfizer at 1 site in Philippines.
Trial summary
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections
- What is being tested?
- Tigecycline (Tygacil)
- Type of treatment
- Injection or infusion
- How many people
- 621 participants
- Where
- 1 sitePhilippines
- Study dates
- Apr 2007to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who receive one dose of tigecycline
Who may be able to join
- All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication.
Who cannot join
- Previously discontinued Tygacil therapy due to significant safety concern.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational Study To Monitor Safety In Patients Who Were Administered With Tigecycline (Tygacil) 50 mg By Intravenous Injection (An Observational Study for Safety - Monitored Release)
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
Read the detailed description
Three-thousand or 10% of total number of patients given tigecycline will be included in the study
- Being tested
- Tigecycline (Tygacil)
- Keywords
- Observational study, Tigecycline, infection, skin, abdominal
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tigecycline (Tygacil)Drug
This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection).
| Study group | Role | What they receive |
|---|---|---|
| A | Not described 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 Spontaneous Adverse Events
Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: "How have you been feeling since your last visit?"
Measured: 30 days post injection up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2010
- Study completionMay 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.
- Other trials for Complicated Skin and Skin Structure 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
- Prospective
- Enrolment
- 621 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
- NCT00683332
- Sponsor's protocol ID
- 3074A1-102235
- Other IDs
- B1811057
- Status last verified
- Jun 2011
- First submitted
- 21 May 2008
- Last updated
- 8 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study To Monitor Safety In Patients Who Were Administered With Tigecycline (Tygacil) 50 mg By Intravenous Injection (An Observational Study for Safety - Monitored Release)
- ClinicalTrials.gov ID
- NCT00683332
- Acronym / sponsor ID
- 3074A1-102235
- Keywords
- Observational study, Tigecycline, infection, skin, abdominal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Posted 8 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
Detailed description
Three-thousand or 10% of total number of patients given tigecycline will be included in the study
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: Tigecycline (Tygacil) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who receive one dose of tigecycline
Key inclusion criteria (1 listed)
- All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication.
Key exclusion criteria (1 listed)
- Previously discontinued Tygacil therapy due to significant safety concern.
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)This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection). | Drug | A |
Primary outcome
Number of Participants With Spontaneous Adverse Events
Time frame: 30 days post injection up to 3 years
Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: "How have you been feeling since your last visit?"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
- 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Skin and Skin Structure Infections and Complicated Intra-abdominal Infections, run by Pfizer at 1 site in Philippines.
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 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
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 8 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?
Number of Participants With Spontaneous Adverse Events (time frame: 30 days post injection up to 3 years). 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 8 Jul 2011.