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Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects

Last updated on November 9, 2019

FOR MORE INFORMATION
Study Location
Toyota-shi, Aichi, 471-8513 Japan
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
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Hospitalized Japanese descent subjects known or suspected to have CAP with a severity
that requires IV antibiotic treatment.

- Chest radiograph within 48 hours before the first dose of IV test article showing the
presence of a new infiltrate.

- The presence of fever or hypothermia within 24 hours before the first administration
of test article, and of at least two signs/symptoms of CAP within 24 hours before the
first administration of test article.

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

- Any concomitant condition that, in the opinion of the investigator, would preclude an
evaluation of a response or make it unlikely that the contemplated course of therapy
could be completed.

- Hospital-acquired pneumonia, other lung disease including viral, fungal, or parasitic
pneumonia, immunosuppressive conditions, and other illness, which affect evaluation of
safety and efficacy of tigecycline.

- Known or suspected hypersensitivity to tigecycline or tetracyclines, or
contraindication for these antibiotics.

NCT00575094
Pfizer
Completed
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects

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Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Official Title  ICMJE A Phase 3, Multicenter, Open-label Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects With Community-acquired Pneumonia
Brief SummaryTo purpose of this study is to assess the safety and tolerability of intravenous (IV) tigecycline in hospitalized subjects of Japanese descent with community-acquired pneumonia (CAP).
Detailed DescriptionThis is a multicenter, open-label study evaluating the safety and efficacy of tigecycline in the treatment of Japanese subjects with CAP. Subjects with clinical signs and symptoms of CAP who meet the eligibility requirements will be considered for enrollment. Qualifying subjects will be assigned to receive tigecycline via IV administration for 7 to 14 consecutive days. The exact duration of administration of the study drug will be at the discretion of the investigator, based on the subject's condition. Subjects will be followed for safety until the test-of-cure (TOC) assessment 10 to 21 days after the last dose of therapy, and for efficacy until TOC assessment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Community-Acquired Infections
Intervention  ICMJE Drug: tigecycline
Dosage form: Tigecycline 50 mg for injection (Lyophilized powder in 5 mL vial) Dosage frequency: Tigecycline 100 mg loading followed by 50 mg every 12 hrs (bid) Duration of therapy: 7 to 14 days
Study Arms  ICMJE Not Provided
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 Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2009)
9
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2007)
70
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion DateMarch 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hospitalized Japanese descent subjects known or suspected to have CAP with a severity that requires IV antibiotic treatment.
  • Chest radiograph within 48 hours before the first dose of IV test article showing the presence of a new infiltrate.
  • The presence of fever or hypothermia within 24 hours before the first administration of test article, and of at least two signs/symptoms of CAP within 24 hours before the first administration of test article.

Exclusion Criteria:

  • Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
  • Hospital-acquired pneumonia, other lung disease including viral, fungal, or parasitic pneumonia, immunosuppressive conditions, and other illness, which affect evaluation of safety and efficacy of tigecycline.
  • Known or suspected hypersensitivity to tigecycline or tetracyclines, or contraindication for these antibiotics.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00575094
Other Study ID Numbers  ICMJE 3074A1-3331
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJune 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

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Pfizer Clinical Trials Contact Center

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