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

NCT03409315 | Unknown

• 1 other identifier: CTDM/FQ1
• Study Type: observational
• Target: 360
• Locations: 13 countries
• Sites: 13

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.

Conditions

Tuberculosis, Multidrug-Resistant

Keywords

Centralized Therapeutic Drug Monitoring; Fluoroquinolones

Outcome Measures

Primary Outcomes (1)

• Feasibility of centralized TDM

  Turn-around time between plasma sampling and receiving dosing advice

  1 week

Secondary Outcomes (1)

• Impact of centralized TDM

  2 months

Study Arms (4)

Moxifloxacin, prospective

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

Procedure: Centralized Therapeutic Drug Monitoring

Levofloxacin, prospective

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

Procedure: Centralized Therapeutic Drug Monitoring

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.

Interventions

Centralized Therapeutic Drug Monitoring 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; Moxifloxacin, prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy or breast feeding

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (13)

The Prince Charles and Caboolture Hospitals

Brisbane, Australia

NOT YET RECRUITING

Republican Scientific and Practical Centre of Pulmonology and Tuberculosis

Minsk, Belarus

NOT YET RECRUITING

Hélio Fraga Reference Center

Rio de Janeiro, Brazil

NOT YET RECRUITING

Athens Chest Hospital "Sotiria"

Athens, Greece

RECRUITING

Alma Mater Studiorum University of Bologna

Bologna, Italy

NOT YET RECRUITING

Reuh Tldc

Upeslejas, Latvia

NOT YET RECRUITING

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico

NOT YET RECRUITING

University Medical Center Groningen Beatrixoord

Haren, Netherlands

NOT YET RECRUITING

Vila Nova Gaia/Espinho Medical School

Vila Nova de Gaia, Portugal

NOT YET RECRUITING

University of Cape Town, Lung Insitute

Cape Town, South Africa

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Sweden

NOT YET RECRUITING

Kibong'oto Infectious Diseases Hospital

Sanya Juu, Tanzania

NOT YET RECRUITING

Royal London Hospital

London, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• van den Elsen SH, Sturkenboom MG, Akkerman O, Barkane L, Bruchfeld J, Eather G, Heysell SK, Hurevich H, Kuksa L, Kunst H, Kuhlin J, Manika K, Moschos C, Mpagama SG, Munoz Torrico M, Skrahina A, Sotgiu G, Tadolini M, Tiberi S, Volpato F, van der Werf TS, Wilson MR, Zuniga J, Touw DJ, Migliori GB, Alffenaar JW. Prospective evaluation of improving fluoroquinolone exposure using centralised therapeutic drug monitoring (TDM) in patients with tuberculosis (PERFECT): a study protocol of a prospective multicentre cohort study. BMJ Open. 2020 Jun 16;10(6):e035350. doi: 10.1136/bmjopen-2019-035350.

  PMID: 32554740 DERIVED

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jan-WIllem Alffenaar, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan-WIllem Alffenaar, PhD

CONTACT

+31503614071; j.w.c.alffenaar@umcg.nl

Simone van den Elsen, BSc

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, PharmD

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: February 10, 2018
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

BE (1); AU (1); ME (1); ZA (1); GB (1); IT (1); BR (1); SE (1); TA (1); NL (1); GR (1); PT (1); LA (1)