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Clinical Trials/NCT03409315
NCT03409315UnknownNot Applicable

Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients

University Medical Center Groningen13 sites in 13 countries360 target enrollmentStarted: February 10, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
360
Locations
13
Primary Endpoint
Feasibility of centralized TDM
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice.

In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pulmonary MDR-TB
  • •Sputum smear and sputum culture positive at baseline
  • •Oral administration of either moxifloxacin or levofloxacin
  • •Written informed consent (for use of the medical data)

Exclusion Criteria

  • •Pregnancy or breast feeding

Outcomes

Primary Outcomes

Feasibility of centralized TDM

Time Frame: 1 week

Turn-around time between plasma sampling and receiving dosing advice

Secondary Outcomes

  • Impact of centralized TDM(2 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jan-Willem C Alffenaar

PhD, PharmD

University Medical Center Groningen

Study Sites (13)

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