Active TuberculosisNCT02042261
The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
An observational study of Active Tuberculosis, run by Thomas Schon at 2 sites in Sweden.
Trial summary
Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance. This concept is defined as therapeutic drug monitoring (TDM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Tuberculosis
- How many people
- 38 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2012to Mar 2016
- How long will I take part?
- 6 Months
- 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: Newly diagnosed patients with culture verified tuberculosis
Who may be able to join
- Age>18 years, culture verified tuberculosis
Who cannot join
- Other infectious diseases other than HIV or tuberculosis
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Dept of Infectious Diseases
Linköping, Linköping, 581 85
Dept of Infectious Diseases, TB-unit, Karolinska Hospital
Stockholm, Stockholm County, 17671
About this study
Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance. This concept is defined as therapeutic drug monitoring (TDM).
In this pilot study our hypothesis is that the ratio between MIC and drug concentration data is correlated to the bacterial load measured as time to positive liquid culture (TTP).
In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12 weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate samples. Clinical follow up according to WHO criteria will be performed 1 year after completion of treatment.
- Conditions
- Active Tuberculosis
- Medical subject headings
- Latent Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rifampicin concentration in relationship to MIC over 10
Measured: 2 weeks
Secondary outcomes (5)
Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2
Measured: 1 year
Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2
Measured: 2 and 8 weeks
TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2
Measured: 8 weeks
Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC)
Measured: 2 and 8 weeks
Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC)
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2012
- Primary completionNov 2015
- Study completionMar 2016
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 Active TuberculosisStudies of the same condition, open and under way.
- 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
- 38 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Thomas Schon
- Sponsor type
- Other government
- Collaborators
- University Hospital, Linkoeping, Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Thomas Schon, Linkoeping University
- Investigators
- Katarina Niward, MD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042261
- Sponsor's protocol ID
- TB-TDM
- Status last verified
- Mar 2016
- First submitted
- 20 Jan 2014
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Niward K, Davies Forsman L, Bruchfeld J, Chryssanthou E, Carlstrom O, Alomari T, Carlsson B, Pohanka A, Mansjo M, Jonsson Nordvall M, Johansson AG, Eliasson E, Werngren J, Paues J, Simonsson USH, Schon T. Distribution of plasma concentrations of first-line anti-TB drugs and individual MICs: a prospective cohort study in a low endemic setting. J Antimicrob Chemother. 2018 Oct 1;73(10):2838-2845. doi: 10.1093/jac/dky268.
PubMed 30124844
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
- ClinicalTrials.gov ID
- NCT02042261
- Acronym / sponsor ID
- TB-TDM
- Conditions
- Active Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Thomas SchonOther government
- Collaborators
- University Hospital, Linkoeping, Karolinska University Hospital
- Study start
- Jan 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Jan 2014 (estimated)
- 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.
Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance. This concept is defined as therapeutic drug monitoring (TDM).
In this pilot study our hypothesis is that the ratio between MIC and drug concentration data is correlated to the bacterial load measured as time to positive liquid culture (TTP).
In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12 weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate samples. Clinical follow up according to WHO criteria will be performed 1 year after completion of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed patients with culture verified tuberculosis
Key inclusion criteria (1 listed)
- Age>18 years, culture verified tuberculosis
Key exclusion criteria (1 listed)
- Other infectious diseases other than HIV or tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rifampicin concentration in relationship to MIC over 10
Time frame: 2 weeks
5 secondary outcomes
Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2
Time frame: 1 year
Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2
Time frame: 2 and 8 weeks
TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2
Time frame: 8 weeks
Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC)
Time frame: 2 and 8 weeks
Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC)
Time frame: 2weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Derived from this study: PubMed 30124844Niward K, Davies Forsman L, Bruchfeld J, Chryssanthou E, Carlstrom O, Alomari T, Carlsson B, Pohanka A, Mansjo M, Jonsson Nordvall M, Johansson AG, Eliasson E, Werngren J, Paues J, Simonsson USH, Schon T. Distribution of plasma concentrations of first-line anti-TB drugs and individual MICs: a prospective cohort study in a low endemic setting. J Antimicrob Chemother. 2018 Oct 1;73(10):2838-2845. doi: 10.1093/jac/dky268.
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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.
Katarina Niward, MD principal investigator
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Active Tuberculosis, run by Thomas Schon at 2 sites in Sweden.
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 1 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: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rifampicin concentration in relationship to MIC over 10 (time frame: 2 weeks). 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 NCT02042261, 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 3 Mar 2016.