Community Acquired InfectionsNCT00488397
Tigecycline In-Vitro Surveillance Study In Taiwan
An observational study of Community Acquired Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in China.
Trial summary
In-vitro surveillance study of tigecycline (Tygacil) in Taiwan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Community Acquired Infections
- What is being tested?
- In-vitro testing
- How many people
- 7,902 participants
- Where
- 1 siteChina
- Study dates
- Aug 2006to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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: hospital or community acquired infection
Who may be able to join
- Clinically relevant causative isolate (no duplicates) - The isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection.
- Sources - All body sites are acceptable clinical sources for isolates to be included in this study (Intra-abdominal infection, tracheal secretion/bronchoalveolar lavage, blood culture, wound smear). However, no more than 10 % of all isolates can come from urine cultures.
- Within study group - Only isolates defined by the protocol are to be included.
Who cannot join
- Limited isolates from sources - No more than 10 % of all isolates from this study will be derived from urine cultures.
- No banked or stored isolates.
- No duplicate isolates - Only one isolate per patient is permitted.
- Outside study group - Any isolate other than those defined by protocol.
Trial locations and contacts
1 site in 1 country.
About this study
In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.
- Conditions
- Community Acquired Infections
- Being tested
- In-vitro testing
- Keywords
- Tygacil, microdilution method, Tigecycline, In-Vitro
- Medical subject headings
- Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-vitro testingOther
This is an in-vitro study thus only one group in the study and there is no intervention treatment nor procedure involved in this study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: In-vitro testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test.
Measured: in vitro study therefore not applicable
Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method
Measured: in vitro study therefore not applicable
Secondary outcomes (2)
Prior to 2009: 1. Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90 by pathogen, tested by micro-dilution method 2. Susceptibility data of inhibition zone diameter(mm) by pathogen, tested by paper disc.
Measured: in vitro study therefore not applicable
Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc.
Measured: in vitro study therefore not applicable
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 startAug 2006
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired InfectionsStudies of the same condition, open and under way.
- 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
- 7,902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488397
- Sponsor's protocol ID
- 3074A1-102091
- Other IDs
- B1811055
- Status last verified
- Mar 2011
- First submitted
- 18 Jun 2007
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tigecycline In-Vitro Surveillance Study In Taiwan
- ClinicalTrials.gov ID
- NCT00488397
- Acronym / sponsor ID
- 3074A1-102091
- Conditions
- Community Acquired Infections
- Keywords
- Tygacil, microdilution method, Tigecycline, In-Vitro
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,902 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: In-vitro testing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hospital or community acquired infection
Key inclusion criteria (3 listed)
- Clinically relevant causative isolate (no duplicates) - The isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection.
- Sources - All body sites are acceptable clinical sources for isolates to be included in this study (Intra-abdominal infection, tracheal secretion/bronchoalveolar lavage, blood culture, wound smear). However, no more than 10 % of all isolates can come from urine cultures.
- Within study group - Only isolates defined by the protocol are to be included.
Key exclusion criteria (4 listed)
- Limited isolates from sources - No more than 10 % of all isolates from this study will be derived from urine cultures.
- No banked or stored isolates.
- No duplicate isolates - Only one isolate per patient is permitted.
- Outside study group - Any isolate other than those defined by protocol.
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 |
|---|---|---|
| In-vitro testingThis is an in-vitro study thus only one group in the study and there is no intervention treatment nor procedure involved in this study. | Other | 1 |
Primary outcome
Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test.
Time frame: in vitro study therefore not applicable
Post-2009: Susceptibility data of MIC, MIC50, MIC90 by pathogen, tested by micro-dilution method
Time frame: in vitro study therefore not applicable
2 secondary outcomes
Prior to 2009: 1. Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90 by pathogen, tested by micro-dilution method 2. Susceptibility data of inhibition zone diameter(mm) by pathogen, tested by paper disc.
Time frame: in vitro study therefore not applicable
Post-2009: Susceptibility data of inhibition zone diameter (mm) by pathogen, tested by paper disc.
Time frame: in vitro study therefore not applicable
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
- 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 Community Acquired Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in China.
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 3 inclusion and 4 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 Mar 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prior to 2009: Susceptibility data of minimum inhibitory concentration (MIC), MIC50, MIC90by pathogen, tested by E-test. (time frame: in vitro study therefore not applicable). The study lists 2 primary outcomes in all. 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 22 Mar 2011.