PK/PD of Ertapenem In Patients With TB
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.
The main objective of this prospective clinical trial is to evaluate pharmacokinetics of a standard dose (2000mg) 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.
A prospective pharmacokinetic study.
Study population: 12 TB patients.
Intervention: Single dose of 2000mg 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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Pharmacokinetics and Pharmacodynamics of Ertapenem in Patients With Tuberculosis|
- 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
- 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)
- 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.
|Study Start Date:||December 2016|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
single dose ertapenem
single dose of 2000mg ertapenem IV
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730664
|Contact: Jan-Willem C Alffenaar, PhD PharmDemail@example.com|
|UMCG - Tuberculosis Center||Recruiting|
|Contact: Jan-Willem C Alffenaar, PhD PharmD +31503614071 firstname.lastname@example.org|
|Principal Investigator: Jan-Willem C Alffenaar, PhD PharmD|