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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
November 9, 2012
November 21, 2012
August 25, 2017
January 26, 2017
July 13, 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01730664 on ClinicalTrials.gov Archive Site
Safety: number of patients with organ dysfunction [ Time Frame: day 1 and day 3 ]
renal function(eGFR) and liver enzymes(ALAT; ASAT)
Same as current
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.
Same as current
 
PK/PD of Ertapenem In Patients With TB
Pharmacokinetics and Pharmacodynamics of Ertapenem in Patients With Tuberculosis

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
PK of Ertapenem in TB Patients
Drug: ertapenem
single dose of 2000mg ertapenem IV
Experimental: ertapenem
single dose ertapenem
Intervention: Drug: ertapenem
Tremblay LW, Fan F, Blanchard JS. Biochemical and structural characterization of Mycobacterium tuberculosis beta-lactamase with the carbapenems ertapenem and doripenem. Biochemistry. 2010 May 4;49(17):3766-73. doi: 10.1021/bi100232q.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 13, 2017
July 13, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01730664
ETB/V0.2
No
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
Not Provided
Jan-Willem C Alffenaar, University Medical Center Groningen
University Medical Center Groningen
Not Provided
Not Provided
University Medical Center Groningen
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP