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PK/PD of Ertapenem In Patients With TB

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01730664
First Posted: November 21, 2012
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan-Willem C Alffenaar, University Medical Center Groningen
  Purpose

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.


Condition Intervention Phase
PK of Ertapenem in TB Patients Drug: ertapenem Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics and Pharmacodynamics of Ertapenem in Patients With Tuberculosis

Resource links provided by NLM:


Further study details as provided by Jan-Willem C Alffenaar, University Medical Center Groningen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Safety: number of patients with organ dysfunction [ Time Frame: day 1 and day 3 ]
    renal function(eGFR) and liver enzymes(ALAT; ASAT)


Other Outcome Measures:
  • 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.


Enrollment: 12
Actual Study Start Date: January 26, 2017
Study Completion Date: July 13, 2017
Primary Completion Date: July 13, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ertapenem
single dose ertapenem
Drug: ertapenem
single dose of 2000mg ertapenem IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with TB, with Mycobacterium tuberculosis (or M. africanum) by culture and / or molecular test
  • Adults: from 18 years until 64 years of age

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 β-lactam antibiotic.
  • Renal Insufficiency, defined by a eGFR of 30ml/min
  • Pregnancy
  • HIV
  • Body weight < 40 kg
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730664


Locations
Netherlands
UMCG - Tuberculosis Center
Groningen, Netherlands
Sponsors and Collaborators
University Medical Center Groningen
  More Information

Publications:
Responsible Party: Jan-Willem C Alffenaar, PhD PharmD Clinical Pharmacologist, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01730664     History of Changes
Other Study ID Numbers: ETB/V0.2
First Submitted: November 9, 2012
First Posted: November 21, 2012
Last Update Posted: August 25, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jan-Willem C Alffenaar, University Medical Center Groningen:
ertapenem
tuberculosis
pharmacokinetics

Additional relevant MeSH terms:
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents