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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03409315




Registration number
NCT03409315
Ethics application status
Date submitted
17/01/2018
Date registered
24/01/2018
Date last updated
10/10/2019

Titles & IDs
Public title
Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients
Scientific title
Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients
Secondary ID [1] 0 0
CTDM/FQ1
Universal Trial Number (UTN)
Trial acronym
PERFECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis, Multidrug-Resistant 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Centralized Therapeutic Drug Monitoring

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

Levofloxacin, prospective - Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin

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.


Treatment: Surgery: 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 code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of centralized TDM
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Impact of centralized TDM
Timepoint [1] 0 0
2 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or breast feeding

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles and Caboolture Hospitals - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Belarus
State/province [1] 0 0
Minsk
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio De Janeiro
Country [3] 0 0
Greece
State/province [3] 0 0
Athens
Country [4] 0 0
Italy
State/province [4] 0 0
Bologna
Country [5] 0 0
Latvia
State/province [5] 0 0
Upeslejas
Country [6] 0 0
Mexico
State/province [6] 0 0
Mexico City
Country [7] 0 0
Netherlands
State/province [7] 0 0
Haren
Country [8] 0 0
Portugal
State/province [8] 0 0
Vila Nova De Gaia
Country [9] 0 0
South Africa
State/province [9] 0 0
Cape Town
Country [10] 0 0
Sweden
State/province [10] 0 0
Stockholm
Country [11] 0 0
Tanzania
State/province [11] 0 0
Sanya Juu
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
University Medical Center Groningen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03409315
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Jan-WIllem Alffenaar, PhD
Address 0 0
UMCG
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jan-WIllem Alffenaar, PhD
Address 0 0
Country 0 0
Phone 0 0
+31503614071
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03409315