PK of Ertapenem in TB Patients Clinical Trial
Official title:
Pharmacokinetics and Pharmacodynamics of Ertapenem in Patients With Tuberculosis
| Verified date | August 2017 |
| Source | University Medical Center Groningen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | July 13, 2017 |
| Est. primary completion date | July 13, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 64 Years |
| Eligibility |
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 ß-lactam antibiotic. - Renal Insufficiency, defined by a eGFR of 30ml/min - Pregnancy - HIV - Body weight < 40 kg |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | UMCG - Tuberculosis Center | Groningen |
| Lead Sponsor | Collaborator |
|---|---|
| University Medical Center Groningen |
Netherlands,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | limited sampling strategies | limited sampling strategies for ertapenem based on a pharmacokinetic population model constructed from the full PK curves of the patients. | day 1 | |
| Primary | AUC | main objective of this prospective clinical trial is to evaluate AUC of a standard dose (1000mg) of ertapenem in TB patients | first day | |
| Secondary | Safety: number of patients with organ dysfunction | renal function(eGFR) and liver enzymes(ALAT; ASAT) | day 1 and day 3 |