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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409315
Recruitment Status : Unknown
Verified October 2019 by Jan-Willem C Alffenaar, University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : January 24, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Jan-Willem C Alffenaar, University Medical Center Groningen

Study Description
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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.


Condition or disease Intervention/treatment
Tuberculosis, Multidrug-Resistant Procedure: Centralized Therapeutic Drug Monitoring

Study Design
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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of centralized TDM [ Time Frame: 1 week ]
    Turn-around time between plasma sampling and receiving dosing advice


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409315


Contacts
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Contact: Jan-WIllem Alffenaar, PhD +31503614071 j.w.c.alffenaar@umcg.nl
Contact: Simone van den Elsen, BSc

Locations
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Australia
The Prince Charles and Caboolture Hospitals Not yet recruiting
Brisbane, Australia
Contact: Andrew Burke         
Belarus
Republican Scientific and Practical Centre of Pulmonology and Tuberculosis Not yet recruiting
Minsk, Belarus
Contact: Alena Skrahina         
Brazil
Hélio Fraga Reference Center Not yet recruiting
Rio De Janeiro, Brazil
Contact: Margareth Dalcolmo         
Greece
Athens Chest Hospital "Sotiria" Recruiting
Athens, Greece
Contact: Charalampos Moschos         
Italy
Alma Mater Studiorum University of Bologna Not yet recruiting
Bologna, Italy
Contact: Marina Tadolini         
Latvia
Reuh Tldc Not yet recruiting
Upeslejas, Latvia
Contact: Liga Kuksa         
Mexico
Instituto Nacional de Enfermedades Respiratorias Not yet recruiting
Mexico City, Mexico
Contact: Marcela Munoz Torrico         
Netherlands
University Medical Center Groningen Beatrixoord Not yet recruiting
Haren, Netherlands
Contact: Onno Akkerman         
Portugal
Vila Nova Gaia/Espinho Medical School Not yet recruiting
Vila Nova De Gaia, Portugal
Contact: Raquel Duarte         
South Africa
University of Cape Town, Lung Insitute Not yet recruiting
Cape Town, South Africa
Contact: Keertan Dheda         
Sweden
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
Contact: Judith Bruchfeld         
Tanzania
Kibong'oto Infectious Diseases Hospital Not yet recruiting
Sanya Juu, Tanzania
Contact: Scott Heysell         
United Kingdom
Royal London Hospital Not yet recruiting
London, United Kingdom
Contact: Simon Tiberi         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Jan-WIllem Alffenaar, PhD UMCG
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jan-Willem C Alffenaar, PhD, PharmD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03409315    
Other Study ID Numbers: CTDM/FQ1
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jan-Willem C Alffenaar, University Medical Center Groningen:
Centralized Therapeutic Drug Monitoring
Fluoroquinolones
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections