PK/PD of Ertapenem In Patients With TB

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 2

Conditions: PK of Ertapenem in TB Patients

Treatments: Drug: ertapenem

Study type: Interventional

Funder types: Other

Identifiers

NCT01730664

ETB/V0.2

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

ertapenem

Experimental group

Description:

single dose ertapenem

Treatment:

Drug: ertapenem