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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
Trial website
Trial related presentations / publications
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
j.w.c.alffenaar@umcg.nl
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03409315