Back to resultsPK/PD of Ertapenem In Patients With TB
Primary Purpose
PK of Ertapenem in TB Patients
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
ertapenem
Sponsored by
About this trial
This is an interventional other trial for PK of Ertapenem in TB Patients focused on measuring ertapenem, tuberculosis, pharmacokinetics
Eligibility 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
Sites / Locations
- UMCG - Tuberculosis Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ertapenem
Arm Description
single dose ertapenem
Outcomes
Primary Outcome Measures
AUC
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
renal function(eGFR) and liver enzymes(ALAT; ASAT)
Full Information
NCT ID
NCT01730664
First Posted
November 9, 2012
Last Updated
August 24, 2017
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT01730664
Brief Title
PK/PD of Ertapenem In Patients With TB
Official Title
Pharmacokinetics and Pharmacodynamics of Ertapenem in Patients With Tuberculosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
July 13, 2017 (Actual)
Study Completion Date
July 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PK of Ertapenem in TB Patients
Keywords
ertapenem, tuberculosis, pharmacokinetics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ertapenem
Arm Type
Experimental
Arm Description
single dose ertapenem
Intervention Type
Drug
Intervention Name(s)
ertapenem
Intervention Description
single dose of 2000mg ertapenem IV
Primary Outcome Measure Information:
Title
AUC
Description
main objective of this prospective clinical trial is to evaluate AUC of a standard dose (1000mg) of ertapenem in TB patients
Time Frame
first day
Secondary Outcome Measure Information:
Title
Safety: number of patients with organ dysfunction
Description
renal function(eGFR) and liver enzymes(ALAT; ASAT)
Time Frame
day 1 and day 3
Other Pre-specified Outcome Measures:
Title
limited sampling strategies
Description
limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full PK curves of the patients.
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UMCG - Tuberculosis Center
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
20353175
Citation
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.
Results Reference
background
Learn more about this trial
PK/PD of Ertapenem In Patients With TB
We'll reach out to this number within 24 hrs