PHARMACOKINETICS AND PHARMACODYNAMICS OF ERTAPENEM IN PATIENTS WITH TUBERCULOSIS

Phase 2

Completed

• Conditions: TB; tuberculosis; 10028440

• Registration Number: NL-OMON43693
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-07-13
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- Patients with tuberculosis, caused by Mycobacterium tuberculosis or by M. africanum
- Adults: from 18 until 64 years of age

Exclusion Criteria

o There are few adverse effects of ertapenem. The only absolute contra-indication is a previous anaphylactic reaction to ertapenem or other *-lactam antibiotic.
o Renal Insufficiency, defined by a eGFR of 30ml/min
o Pregnancy
o HIV
o Body weight < 40 kg

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective of this prospective clinical trial is to characterise the<br /><br>pharmacokinetics of ertapenem in tuberculosis patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate T>MIC and AUC/MIC ratio<br /><br>To evaluate limited sampling strategies based on a pharmacokinetic population<br /><br>model to predict ertapenem AUC0-24h<br /><br>To evaluate alternative blood sampling </p><br>