Clinical trial NCT03409315: Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients
Official title: Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis, Multidrug-Resistant
Keywords: Centralized Therapeutic Drug Monitoring
Fluoroquinolones
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of centralized TDM
timeFrame: 1 week
Secondary outcomes:
measure: Impact of centralized TDM
timeFrame: 2 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The Prince Charles and Caboolture Hospitals
city: Minsk
country: Belarus
facility: Republican Scientific and Practical Centre of Pulmonology and Tuberculosis
city: Rio De Janeiro
country: Brazil
facility: Hélio Fraga Reference Center
city: Athens
country: Greece
facility: Athens Chest Hospital "Sotiria"
city: Bologna
country: Italy
facility: Alma Mater Studiorum University of Bologna
city: Upeslejas
country: Latvia
facility: Reuh Tldc
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias
city: Haren
country: Netherlands
facility: University Medical Center Groningen Beatrixoord
city: Vila Nova De Gaia
country: Portugal
facility: Vila Nova Gaia/Espinho Medical School
city: Cape Town
country: South Africa
facility: University of Cape Town, Lung Insitute
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Sanya Juu
country: Tanzania
facility: Kibong'oto Infectious Diseases Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: UMCG
name: Jan-WIllem Alffenaar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.