Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-10

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tuberculosis, Multidrug-Resistant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moxifloxacin, prospective

Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin.

Centralized Therapeutic Drug Monitoring

Intervention Type PROCEDURE

Plasma samples will be drawn at peripheral centres en shipped to a central laboratory for analysis. Results and dosing advice will be returned by email to local physician.

Levofloxacin, prospective

Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin

Centralized Therapeutic Drug Monitoring

Intervention Type PROCEDURE

Plasma samples will be drawn at peripheral centres en shipped to a central laboratory for analysis. Results and dosing advice will be returned by email to local physician.

Moxifloxacin, historical controls

Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of moxifloxacin.

No interventions assigned to this group

Levofloxacin, historical controls

Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of levofloxacin.

No interventions assigned to this group

Interventions

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Centralized Therapeutic Drug Monitoring

Plasma samples will be drawn at peripheral centres en shipped to a central laboratory for analysis. Results and dosing advice will be returned by email to local physician.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jan-Willem C Alffenaar

PhD, PharmD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan-WIllem Alffenaar, PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

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