PK/PD of Ertapenem In Patients With TB
|ClinicalTrials.gov Identifier: NCT01730664|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : August 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|PK of Ertapenem in TB Patients||Drug: ertapenem||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics and Pharmacodynamics of Ertapenem in Patients With Tuberculosis|
|Actual Study Start Date :||January 26, 2017|
|Primary Completion Date :||July 13, 2017|
|Study Completion Date :||July 13, 2017|
single dose ertapenem
single dose of 2000mg ertapenem IV
- AUC [ Time Frame: first day ]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 ]renal function(eGFR) and liver enzymes(ALAT; ASAT)
- limited sampling strategies [ Time Frame: day 1 ]limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full PK curves of the patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730664
|UMCG - Tuberculosis Center|