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Tigecycline In-Vitro Surveillance Study In Taiwan

Last updated on November 10, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Taipei, Taiwan, 100 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community Acquired Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00488397
Pfizer
Completed
Tigecycline In-Vitro Surveillance Study In Taiwan

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Descriptive Information
Brief TitleTigecycline In-Vitro Surveillance Study In Taiwan
Official TitleTigecycline In-Vitro Surveillance Study In Taiwan
Brief SummaryIn-vitro surveillance study of tigecycline (Tygacil) in Taiwan.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationhospital or community acquired infection
ConditionCommunity Acquired Infections
InterventionOther: In-vitro testing
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 Groups/Cohorts1
Intervention: Other: In-vitro testing
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: March 11, 2011)
7902
Original Enrollment
 (submitted: June 18, 2007)
6000
Actual Study Completion DateFebruary 2011
Actual Primary Completion DateFebruary 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesChina
Removed Location CountriesTaiwan
 
Administrative Information
NCT NumberNCT00488397
Other Study ID Numbers3074A1-102091
B1811055 ( Other Identifier: Pfizer )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMarch 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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