PK/PD of Ertapenem In Patients With TB
| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2012 | ||||
| Last Updated Date | February 4, 2013 | ||||
| Start Date ICMJE | February 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
AUC [ Time Frame: first day ] [ Designated as safety issue: No ] main objective of this prospective clinical trial is to evaluate AUC of a standard dose (1000mg) of ertapenem in TB patients |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01730664 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety: number of patients with organ dysfunction [ Time Frame: day 1 and day 3 ] [ Designated as safety issue: Yes ] renal function(eGFR) and liver enzymes(ALAT; ASAT) |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE |
limited sampling strategies [ Time Frame: day 1 ] [ Designated as safety issue: No ] limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full PK curves of the patients. |
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| Original Other Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | PK/PD of Ertapenem In Patients With TB | ||||
| Official Title ICMJE | Pharmacokinetics and Pharmacodynamics of Ertapenem in Patients With Tuberculosis | ||||
| Brief Summary | Rationale: Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real challenge as failure in response to treatment and serious side-effects are frequently encountered. New, more effective drugs with less side effects are therefore urgently needed to solve this problem. Although several new drugs against TB are in the pipeline, physicians currently have limited treatment options for treatment of complicated MDR/XDR-TB cases. Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB. Objective: The main objective of this prospective clinical trial is to evaluate pharmacokinetics of a standard dose (1000mg) of ertapenem in TB patients. This clinical trial will provide important information on PK of ertapenem in TB patients for future studies. Data can be used for limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full PK curves of the patients. Study design: A prospective pharmacokinetic study. Study population: 12 TB patients. Intervention: Single dose of 1000mg in a 30 minutes intravenous infusion. Main study parameters/endpoints: The pharmacokinetic parameters (Vd, Cl, AUC, etc) of ertapenem are the primary endpoints of the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most likely the best predictive parameters for efficacy of ertapenem treatment and will be calculated for a range of M tuberculosis isolates. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | PK of Ertapenem in TB Patients | ||||
| Intervention ICMJE | Drug: ertapenem
single dose of 1000mg ertapenem IV |
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| Study Arm (s) | Experimental: ertapenem
single dose ertapenem
Intervention: Drug: ertapenem |
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| Publications * | Tremblay LW, Fan F, Blanchard JS. Biochemical and structural characterization of Mycobacterium tuberculosis beta-lactamase with the carbapenems ertapenem and doripenem. Biochemistry. 2010 May 4;49(17):3766-73. | ||||
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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 | 12 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: -Contra-indications for ertapenem:
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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01730664 | ||||
| Other Study ID Numbers ICMJE | ETB/V0.2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | JWC Alffenaar, University Medical Centre Groningen | ||||
| Study Sponsor ICMJE | University Medical Centre Groningen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University Medical Centre Groningen | ||||
| Verification Date | February 2013 | ||||
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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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