Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients
This study is currently recruiting participants.
Verified February 2012 by National Taiwan University Hospital
Sponsor:
National Taiwan University Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01600768
First received: May 16, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | May 16, 2012 | ||||
| Last Updated Date | May 16, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
serum concentrations of beta-lactams [ Time Frame: 6 hours ] [ Designated as safety issue: No ] Determination of serum concentrations of beta-lactams |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of extended infusion of beta-lactams in intensive care patients who are infected with Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Gram-Negative Bacterial Infections | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01600768 | ||||
| Other Study ID Numbers ICMJE | 200912104M | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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