NCT01730664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
4.2 years until next milestone

Study Start

First participant enrolled

January 26, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

November 9, 2012

Last Update Submit

August 24, 2017

Conditions

PK of Ertapenem in TB Patients

Keywords

ertapenemtuberculosispharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety: number of patients with organ dysfunction

    day 1 and day 3

Other Outcomes (1)

  • limited sampling strategies

    day 1

Study Arms (1)

ertapenem

EXPERIMENTAL

single dose ertapenem

Drug: ertapenem

Interventions

ertapenemDRUG

single dose of 2000mg ertapenem IV

ertapenem

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with TB, with Mycobacterium tuberculosis (or M. africanum) by culture and / or molecular test
  • Adults: from 18 years until 64 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCG - Tuberculosis Center

Groningen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 20353175BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD PharmD Clinical Pharmacologist

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 21, 2012

Study Start

January 26, 2017

Primary Completion

July 13, 2017

Study Completion

July 13, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

NL(1)