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

October 8, 2019 updated by: Jan-Willem C Alffenaar, University Medical Center Groningen

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Simone van den Elsen, BSc

Study Locations

  • Australia
      • Brisbane, Australia
        • Not yet recruiting
        • The Prince Charles and Caboolture Hospitals
        • Contact:
          • Andrew Burke
  • Belarus
      • Minsk, Belarus
        • Not yet recruiting
        • Republican Scientific and Practical Centre of Pulmonology and Tuberculosis
        • Contact:
          • Alena Skrahina
  • Brazil
      • Rio De Janeiro, Brazil
        • Not yet recruiting
        • Hélio Fraga Reference Center
        • Contact:
          • Margareth Dalcolmo
  • Greece
      • Athens, Greece
        • Recruiting
        • Athens Chest Hospital "Sotiria"
        • Contact:
          • Charalampos Moschos
  • Italy
      • Bologna, Italy
        • Not yet recruiting
        • Alma Mater Studiorum University of Bologna
        • Contact:
          • Marina Tadolini
  • Latvia
      • Upeslejas, Latvia
        • Not yet recruiting
        • Reuh Tldc
        • Contact:
          • Liga Kuksa
  • Mexico
      • Mexico City, Mexico
        • Not yet recruiting
        • Instituto Nacional de Enfermedades Respiratorias
        • Contact:
          • Marcela Munoz Torrico
  • Netherlands
      • Haren, Netherlands
        • Not yet recruiting
        • University Medical Center Groningen Beatrixoord
        • Contact:
          • Onno Akkerman
  • Portugal
      • Vila Nova De Gaia, Portugal
        • Not yet recruiting
        • Vila Nova Gaia/Espinho Medical School
        • Contact:
          • Raquel Duarte
  • South Africa
      • Cape Town, South Africa
        • Not yet recruiting
        • University of Cape Town, Lung Insitute
        • Contact:
          • Keertan Dheda
  • Sweden
      • Stockholm, Sweden
        • Not yet recruiting
        • Karolinska University Hospital
        • Contact:
          • Judith Bruchfeld
  • Tanzania
      • Sanya Juu, Tanzania
        • Not yet recruiting
        • Kibong'oto Infectious Diseases Hospital
        • Contact:
          • Scott Heysell
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Royal London Hospital
        • Contact:
          • Simon Tiberi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Sputum smear and culture positive MDR-TB patients treated with either moxifloxacin or levofloxacin in multiple clinical centres worldwide.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Moxifloxacin, prospective
Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin.
Procedure: 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.
Levofloxacin, prospective
Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin
Procedure: 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.
Moxifloxacin, historical controls
Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of moxifloxacin.
Levofloxacin, historical controls
Historical controls (n=120) matched to prospective patients, did not receive centralized therapeutic drug monitoring of levofloxacin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of centralized TDM
Time Frame: 1 week
Turn-around time between plasma sampling and receiving dosing advice
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of centralized TDM
Time Frame: 2 months
Comparison of % patients with converted sputum smear and culture between prospective patients with TDM and matched historical controls without TDM (1:2)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Jan-WIllem Alffenaar, PhD, UMCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2018

Primary Completion (ANTICIPATED)

November 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (ACTUAL)

January 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTDM/FQ1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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