Tuberculosis, Multidrug-ResistantPERFECTNCT03409315
Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients
An observational study of Tuberculosis, Multidrug-Resistant, run by University Medical Center Groningen at 13 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Multidrug-Resistant
- What is being tested?
- Centralized Therapeutic Drug Monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 13 sitesin 13 countries
- Study dates
- 10 Feb 2018to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sputum smear and culture positive MDR-TB patients treated with either moxifloxacin or levofloxacin in multiple clinical centres worldwide.
Who may be able to join
- 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)
Who cannot join
- Pregnancy or breast feeding
Trial locations and contacts
13 sites in 13 countries.
Simone van den Elsen, BSc contact
13 sites in 13 countries
Australia1 site, 1 recruiting
- Not yet recruiting
The Prince Charles and Caboolture Hospitals
Brisbane
Andrew Burke
Belarus1 site, 1 recruiting
- Not yet recruiting
Republican Scientific and Practical Centre of Pulmonology and Tuberculosis
Minsk
Alena Skrahina
Brazil1 site, 1 recruiting
- Not yet recruiting
Hélio Fraga Reference Center
Rio de Janeiro
Margareth Dalcolmo
Greece1 site, 1 recruiting
- Recruiting
Athens Chest Hospital "Sotiria"
Athens
Charalampos Moschos
Italy1 site, 1 recruiting
- Not yet recruiting
Alma Mater Studiorum University of Bologna
Bologna
Marina Tadolini
Mexico1 site, 1 recruiting
- Not yet recruiting
Instituto Nacional de Enfermedades Respiratorias
Mexico City
Marcela Munoz Torrico
Netherlands1 site, 1 recruiting
- Not yet recruiting
University Medical Center Groningen Beatrixoord
Haren
Onno Akkerman
Portugal1 site, 1 recruiting
- Not yet recruiting
Vila Nova Gaia/Espinho Medical School
Vila Nova de Gaia
Raquel Duarte
South Africa1 site, 1 recruiting
- Not yet recruiting
University of Cape Town, Lung Insitute
Cape Town
Keertan Dheda
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm
Judith Bruchfeld
Tanzania1 site, 1 recruiting
- Not yet recruiting
Kibong'oto Infectious Diseases Hospital
Sanya Juu
Scott Heysell
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Royal London Hospital
London
Simon Tiberi
About this study
Official title: Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients
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
- Being tested
- Centralized Therapeutic Drug Monitoring
- Keywords
- Centralized Therapeutic Drug Monitoring, Fluoroquinolones
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized Therapeutic Drug MonitoringProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin, prospective | Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin. Receives: Procedure: Centralized Therapeutic Drug Monitoring | |
| Levofloxacin, prospective | Prospective included patients (n=60) receiving centralized therapeutic drug monitoring of levofloxacin Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of centralized TDM
Turn-around time between plasma sampling and receiving dosing advice
Measured: 1 week
Secondary outcomes (1)
Impact of centralized TDM
Comparison of % patients with converted sputum smear and culture between prospective patients with TDM and matched historical controls without TDM (1:2)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start10 Feb 2018
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, Multidrug-ResistantStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Willem C Alffenaar, University Medical Center Groningen
- Investigators
- Jan-WIllem Alffenaar, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409315
- Sponsor's protocol ID
- CTDM/FQ1
- Acronym
- PERFECT
- Status last verified
- Oct 2019
- First submitted
- 17 Jan 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32554740
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients
- ClinicalTrials.gov ID
- NCT03409315
- Acronym / sponsor ID
- PERFECT / CTDM/FQ1
- Conditions
- Tuberculosis, Multidrug-Resistant
- Keywords
- Centralized Therapeutic Drug Monitoring, Fluoroquinolones
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin, prospective | – | Procedure: Centralized Therapeutic Drug MonitoringProspective included patients (n=60) receiving centralized therapeutic drug monitoring of moxifloxacin. |
| Levofloxacin, prospective | – | Procedure: Centralized Therapeutic Drug MonitoringProspective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sputum smear and culture positive MDR-TB patients treated with either moxifloxacin or levofloxacin in multiple clinical centres worldwide.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centralized Therapeutic Drug MonitoringPlasma 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. | Procedure or surgery | Levofloxacin, prospective, Moxifloxacin, prospective |
Primary outcome
Feasibility of centralized TDM
Time frame: 1 week
Turn-around time between plasma sampling and receiving dosing advice
1 secondary outcome
Impact of centralized TDM
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Derived from this study: PubMed 32554740van 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.
Related trials for Tuberculosis, Multidrug-Resistant
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
Recruiting
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Drug Resistant Tuberculosis
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone van den Elsen, BSc contact
Jan-WIllem Alffenaar, PhD principal investigator
University Medical Center Groningen
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Multidrug-Resistant, run by University Medical Center Groningen at 13 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia, Belarus, Brazil, Greece, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan-WIllem Alffenaar, PhD (+31503614071, j.w.c.alffenaar@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of centralized TDM (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03409315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.