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 (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.
Study design:
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.