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PK/PD of Ertapenem In Patients With TB

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by University Medical Center Groningen
Sponsor:
Information provided by (Responsible Party):
JWC Alffenaar, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT01730664
First received: November 9, 2012
Last updated: September 1, 2016
Last verified: September 2016
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics and Pharmacodynamics of Ertapenem in Patients With Tuberculosis

Resource links provided by NLM:


Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • AUC [ Time Frame: first day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    renal function(eGFR) and liver enzymes(ALAT; ASAT)


Other Outcome Measures:
  • limited sampling strategies [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full PK curves of the patients.


Estimated Enrollment: 12
Study Start Date: October 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730664

Contacts
Contact: Jan-Willem C Alffenaar, PhD PharmD +31503614071 j.w.c.alffenaar@umcg.nl

Locations
Netherlands
UMCG - Tuberculosis Center Recruiting
Groningen, Netherlands
Contact: Jan-Willem C Alffenaar, PhD PharmD    +31503614071    j.w.c.alffenaar@umcg.nl   
Principal Investigator: Jan-Willem C Alffenaar, PhD PharmD         
Sponsors and Collaborators
University Medical Center Groningen
  More Information

Publications:
Responsible Party: JWC Alffenaar, PhD PharmD Clinical Pharmacologist, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01730664     History of Changes
Other Study ID Numbers: ETB/V0.2 
Study First Received: November 9, 2012
Last Updated: September 1, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Center Groningen:
ertapenem
tuberculosis
pharmacokinetics

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

ClinicalTrials.gov processed this record on December 06, 2016