BLOOD CONCENTRATION OF ERTAPENEM IN PATIENTS WITH TUBERCULOSIS

• Conditions: Tuberculosis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-003386-18-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-23
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To evaluate limited sampling strategies based on a pharmacokinetic population model to predict ertapenem AUC0-24h<br>To evaluate variation in protein binding<br>To evaluate infusion reactions ;Primary end point(s): pharmacokinetics;Timepoint(s) of evaluation of this end point: 1 day

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): T>MIC and AUC/MIC ratio<br>variation in protein binding<br>infusion reactions ;Timepoint(s) of evaluation of this end point: first day