Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
NCT00230971
Last updated date
ABOUT THIS STUDY
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus
metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy
through the test-of-cure assessment. Safety evaluations will occur through the treatment and
post-treatment periods and continue through resolution or stability of the adverse event(s).
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
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Appendicitis, Cholecystitis, Diverticulitis, Intra-Abdominal Abscess, Intra-Abdominal Infection, Peritonitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
- Fever plus other symptoms such as nausea, vomiting, abdominal pain.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Cancer
- Medicines that suppress the immune system
- Dialysis
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Appendicitis, Cholecystitis, Diverticulitis, Intra-Abdominal Abscess, Intra-Abdominal Infection, PeritonitisStudy Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
NCT00230971
- Nambour, Queensland
- Cairns,
- Parkville,
- Shanghai,
- Odense,
- Lahti,
- Seinajoki,
- Tampere,
- Marseille,
- Nimes,
- Pierre Benite,
- Saint Denis,
- Bochum,
- Frankfurt,
- Freiburg,
- Heidelberg,
- Leipzig,
- Luebeck,
- Muenster,
- Tuebingen,
- Athens,
- Athens,
- Thessaloniki,
- New Territories,
- Pokfulam,
- Hyderabad, Andhra
- Bhopal,
- Lucknow,
- Mumbai,
- New Delhi,
- Brescia,
- Genova,
- Pavia,
- Rome,
- Udine,
- Vicenza,
- Manila,
- Quezon City,
- Quezon City,
- Almada,
- Coimbra,
- Porto,
- Porto,
- Riyadh,
- Bellville,
- Kuilsriver,
- Parow,
- Pietermaritzburg,
- Pretoria,
- Barcelona,
- Bilbao,
- Madrid,
- Madrid,
- Murcia,
- Bern,
- Geneva,
- Lugano,
- Zurich,
- Changhua,
- Taichung,
- Tainan,
- Taipei,
- Tao-yuan,
- Ankara,
- Istanbul,
- Stockport, Cheshire
- Birmingham,
- Wigan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||||||||||||||||||||||||||||||||
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| Brief Title ICMJE | Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) | ||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection | ||||||||||||||||||||||||||||||||||||
| Brief Summary | This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s). | ||||||||||||||||||||||||||||||||||||
| Detailed Description | Not Provided | ||||||||||||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||
| Study Phase ICMJE | Phase 4 | ||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||||||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22. | ||||||||||||||||||||||||||||||||||||
* 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 | 473 | ||||||||||||||||||||||||||||||||||||
| Original Enrollment ICMJE | 430 | ||||||||||||||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | September 2008 | ||||||||||||||||||||||||||||||||||||
| Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 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 | Australia, China, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom | ||||||||||||||||||||||||||||||||||||
| Removed Location Countries | Czech Republic | ||||||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00230971 | ||||||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 3074A1-315 | ||||||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||
| Verification Date | February 2013 | ||||||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||||||||||||||||||||||||||||||