Tuberculosis
Conditions
Interventions
Trade Name: INVANZ
Pharmaceutical Form: Powder for infusion
Sponsors
UMCG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: UMCG, tuberculosis center Beatrixoord Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contra-indications for ertapenem: There are few adverse effects of ertapenem. The only absolute contra-indication is a previous anaphylactic reaction to ertapenem or other ß-lactam antibiotic. Renal Insufficiency, defined by a eGFR of 30ml/min Pregnancy HIV Body weight < 40 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate pharmacokinetics of a standard dose (1000mg) of ertapenem in TB patients. ;Secondary Objective: To evaluate T>MIC and AUC/MIC ratio To evaluate limited sampling strategies based on a pharmacokinetic population model to predict ertapenem AUC0-24h To evaluate variation in protein binding To evaluate infusion reactions ;Primary end point(s): pharmacokinetics;Timepoint(s) of evaluation of this end point: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): T>MIC and AUC/MIC ratio variation in protein binding infusion reactions ;Timepoint(s) of evaluation of this end point: first day | — |
Countries
Netherlands
Contacts
Public ContactKF&A
UMCG
Outcome results
None listed