Nontuberculous Mycobacterial DiseasesNTMNCT01051752
PK and PD of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients
An observational study of Nontuberculous Mycobacterial Diseases, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nontuberculous Mycobacterial Diseases
- How many people
- 26 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2010to May 2011
- 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: Patients with NTM infection are generally middle aged or higher aged, white males with COPD or bronchiectasis. They will be recruited from the outpatient clinics of University Centre for Chronic Diseases Dekkerswald, Tuberculosis Centre Beatrixoord or other outpatient clinics in The Netherlands. Both newly diagnosed and already treated patients with NTM disease will be recruited.
Who may be able to join
- currently treated for NTM infection or recently diagnosed with NTM infection starting treatment at University Centre for Chronic Diseases Dekkerswald (Groesbeek), Centre for Revalidation Beatrixoord (Haren), or other outpatient clinics in The Netherlands.
- Diagnosis and treatment according to American Thoracic Society (ATS) criteria for NTM infections. Patients with pulmonary NTM infections (possible with extrapulmonary localizations as well) are eligible
- Treated with at least rifampicin and ethambutol and optionally with isoniazid, clarithromycin or azithromycin on a daily basis
- Age at least 18 years
- Patient has been using drugs for at least two weeks when steady state concentrations of the used drugs are expected
- Informed consent has been signed
Who cannot join
- The medical state of the patients does not allow inclusion according to the physician in attendance.
- The patients' clinical parameters urge immediate cessation of drugs.
- The patient is pregnant.
- Significant hepatic or renal dysfunction based on chemistry parameters (grade 1 according to an international adverse event grading system, see http:/ctep.cancer.gov) or symptomatic liver dysfunction (nausea and vomiting).
- Patients with cystic fibrosis, since these show deviating pharmacokinetics for many drugs.
- Patients with HIV infection, since these may show deviating pharmacokinetics for the drugs used in NTM disease.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Centre Groningen
Groningen, Provincie Groningen
Radboud University Medical Centre Nijmegen
Nijmegen, Gelderland
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients
A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.
Read the detailed description
NTM are widely distributed in the environment and can especially be found in soil and water sources. These bacteria a very similar to tuberculosis bacteria. We are not that long aware that these bacteria can cause illness. Especially in patients with a chronic lung disease are sensitive to these bacteria and are susceptible to develop an infection. A lot of ambiguity consists about the best treatment of these infections. Up till now mainly the normal treatment for tuberculosis is used, however, the time period during which these medicines should be used and what dose should be used is mainly unknown.
To investigate whether the dose used at this moment is right a pharmacokinetic curve will be taken at steady-state.
- Conditions
- Nontuberculous Mycobacterial Diseases
- Keywords
- Nontuberculous mycobacterial diseases, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NTM infection | Patients with NTM infection are generally middle aged or higher aged, white males with COPD or bronchiectasis. They will be recruited from the outpatient clinics of University Centre for Chronic Diseases Dekkerswald, Tuberculosis Centre Beatrixoord or other outpatient clinics in The Netherlands. Both newly diagnosed and already treated patients with NTM disease will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment
Measured: after at least 2 weeks of treatment
Secondary outcomes (3)
Determinants of pharmacokinetic parameters
Measured: after at least 2 weeks of treatment
Assessment of MIC values and pharmacodynamic parameters for response
Measured: once a month starting after two weeks of treatment;last assessment at 6 months
Association of pharmacokinetic and pharmacodynamic parameters with treatment outcome and toxicity
Measured: entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontuberculous Mycobacterial DiseasesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Aarnoutse, Pharm D PhD, Principal investigator, Radboud University Medical CenterJan- Willem Alffenaar, PharmD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051752
- Sponsor's protocol ID
- NL29420.091.09
- Acronym
- NTM
- Status last verified
- May 2012
- First submitted
- 18 Jan 2010
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients
- ClinicalTrials.gov ID
- NCT01051752
- Acronym / sponsor ID
- NTM / NL29420.091.09
- Conditions
- Nontuberculous Mycobacterial Diseases
- Keywords
- Nontuberculous mycobacterial diseases, pharmacokinetics, pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 Jan 2010 (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.
A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.
Detailed description
NTM are widely distributed in the environment and can especially be found in soil and water sources. These bacteria a very similar to tuberculosis bacteria. We are not that long aware that these bacteria can cause illness. Especially in patients with a chronic lung disease are sensitive to these bacteria and are susceptible to develop an infection. A lot of ambiguity consists about the best treatment of these infections. Up till now mainly the normal treatment for tuberculosis is used, however, the time period during which these medicines should be used and what dose should be used is mainly unknown.
To investigate whether the dose used at this moment is right a pharmacokinetic curve will be taken at steady-state.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTM infection | – | –Patients with NTM infection are generally middle aged or higher aged, white males with COPD or bronchiectasis. They will be recruited from the outpatient clinics of University Centre for Chronic Diseases Dekkerswald, Tuberculosis Centre Beatrixoord or other outpatient clinics in The Netherlands. Both newly diagnosed and already treated patients with NTM disease will be recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NTM infection are generally middle aged or higher aged, white males with COPD or bronchiectasis. They will be recruited from the outpatient clinics of University Centre for Chronic Diseases Dekkerswald, Tuberculosis Centre Beatrixoord or other outpatient clinics in The Netherlands. Both newly diagnosed and already treated patients with NTM disease will be recruited.
Key inclusion criteria (6 listed)
- currently treated for NTM infection or recently diagnosed with NTM infection starting treatment at University Centre for Chronic Diseases Dekkerswald (Groesbeek), Centre for Revalidation Beatrixoord (Haren), or other outpatient clinics in The Netherlands.
- Diagnosis and treatment according to American Thoracic Society (ATS) criteria for NTM infections. Patients with pulmonary NTM infections (possible with extrapulmonary localizations as well) are eligible
- Treated with at least rifampicin and ethambutol and optionally with isoniazid, clarithromycin or azithromycin on a daily basis
- Age at least 18 years
- Patient has been using drugs for at least two weeks when steady state concentrations of the used drugs are expected
Key exclusion criteria (6 listed)
- The medical state of the patients does not allow inclusion according to the physician in attendance.
- The patients' clinical parameters urge immediate cessation of drugs.
- The patient is pregnant.
- Significant hepatic or renal dysfunction based on chemistry parameters (grade 1 according to an international adverse event grading system, see http:/ctep.cancer.gov) or symptomatic liver dysfunction (nausea and vomiting).
- Patients with cystic fibrosis, since these show deviating pharmacokinetics for many drugs.
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
Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment
Time frame: after at least 2 weeks of treatment
3 secondary outcomes
Determinants of pharmacokinetic parameters
Time frame: after at least 2 weeks of treatment
Assessment of MIC values and pharmacodynamic parameters for response
Time frame: once a month starting after two weeks of treatment;last assessment at 6 months
Association of pharmacokinetic and pharmacodynamic parameters with treatment outcome and toxicity
Time frame: entire study
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 22 May 2012.
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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.
Rob Aarnoutse, Pharm D PhD principal investigator
Radboud University Medical Center
Jan- Willem Alffenaar, PharmD PhD principal investigator
University Medical Center Groningen
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 Nontuberculous Mycobacterial Diseases, run by Radboud University Medical Center at 2 sites in Netherlands.
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 6 inclusion and 6 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 22 May 2012. 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 Netherlands. 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?
Pharmacokinetic parameters of antimycobacterial drugs in NTM treatment (time frame: after at least 2 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2012.