TuberculosisNCT02169141
Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients
An observational study of Tuberculosis, run by University Medical Center Groningen at 1 site in Belarus.
Trial summary
This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Pharmacokinetics
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteBelarus
- Study dates
- Nov 2012to Nov 2013
- 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: MDR-TB patients
Who may be able to join
- age> 18yrs
- culture positive
- diagnosis of MDR-TB
Who cannot join
- DM2
- Pregnancy
- allergy to IV canula material
- insertion of IV canula not possibele
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Republican Scientific and Practical Center for TB and Pulmonology
Minsk, 220053
About this study
Official title: Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients
This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).
Read the detailed description
Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatment, the PK samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.
- Conditions
- Tuberculosis
- Being tested
- Pharmacokinetics
- Keywords
- pharmacokinetics, pharmacodynamics, MDR-TB, Levofloxacin, Capreomycin
- Medical subject headings
- Tuberculosis, Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacokineticsOther
multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters
| Study group | Role | What they receive |
|---|---|---|
| PK of Levofloxacin-Capreomycin | Pharmacokinetics (PK) in M/XDR-TB patients receiving at least Levofloxacin and Capreomycin as part of their WHO treatment for M/XDR-TB Receives: Other: Pharmacokinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC/MIC ratio of Levofloxacin
The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the area under the serum concentration-time curve (AUC) over 24 hours (AUC0-24h ), [AUC0-24h /MIC], after administration of Levofloxacin.
Measured: after day 8 of treatment
Cmax/MIC ratio of Capreomycin
The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the maximum serum concentration, [Cmax/MIC], after administration of Capreomycin.
Measured: after day 8 of treatment
Secondary outcomes (2)
Volume of Distribution
Based on the measured drug concentration during the dosing interval and patient characteristics (height, bodyweight and age) the volume of distribution will be calculated
Measured: after day 8 of treatment
Clearance
Based on the drug concetrations during the dosing interval and patient characteristics (height, bodyweight, age) the drug clearance will be calculated
Measured: after day 8 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Republican Scientific and Practical Centre for Pulmonology and TB, National Institute for Public Health and the Environment (RIVM)
- Responsible party
- Principal investigator, JWC Alffenaar, University Medical Center Groningen
- Investigators
- JW C Alffenaar, PhD PharmD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169141
- Sponsor's protocol ID
- LC-20
- Status last verified
- Jun 2014
- First submitted
- 12 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Van't Boveneind-Vrubleuskaya N, Seuruk T, van Hateren K, van der Laan T, Kosterink JGW, van der Werf TS, van Soolingen D, van den Hof S, Skrahina A, Alffenaar JC. Pharmacokinetics of Levofloxacin in Multidrug- and Extensively Drug-Resistant Tuberculosis Patients. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00343-17. doi: 10.1128/AAC.00343-17. Print 2017 Aug.
PubMed 28507117Velasquez AMA, Ribeiro WC, Venn V, Castelli S, Camargo MS, de Assis RP, de Souza RA, Ribeiro AR, Passalacqua TG, da Rosa JA, Baviera AM, Mauro AE, Desideri A, Almeida-Amaral EE, Graminha MAS. Efficacy of a Binuclear Cyclopalladated Compound Therapy for Cutaneous Leishmaniasis in the Murine Model of Infection with Leishmania amazonensis and Its Inhibitory Effect on Topoisomerase 1B. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00688-17. doi: 10.1128/AAC.00688-17. Print 2017 Aug.
PubMed 28507113
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients
- ClinicalTrials.gov ID
- NCT02169141
- Acronym / sponsor ID
- LC-20
- Conditions
- Tuberculosis
- Keywords
- pharmacokinetics, pharmacodynamics, MDR-TB, Levofloxacin, Capreomycin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Republican Scientific and Practical Centre for Pulmonology and TB, National Institute for Public Health and the Environment (RIVM)
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Jun 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.
This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).
Detailed description
Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatment, the PK samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PK of Levofloxacin-Capreomycin | – | Other: PharmacokineticsPharmacokinetics (PK) in M/XDR-TB patients receiving at least Levofloxacin and Capreomycin as part of their WHO treatment for M/XDR-TB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MDR-TB patients
Key inclusion criteria (3 listed)
- age> 18yrs
- culture positive
- diagnosis of MDR-TB
Key exclusion criteria (4 listed)
- DM2
- Pregnancy
- allergy to IV canula material
- insertion of IV canula not possibele
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 |
|---|---|---|
| Pharmacokineticsmultiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters | Other | PK of Levofloxacin-Capreomycin |
Primary outcome
AUC/MIC ratio of Levofloxacin
Time frame: after day 8 of treatment
The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the area under the serum concentration-time curve (AUC) over 24 hours (AUC0-24h ), [AUC0-24h /MIC], after administration of Levofloxacin.
Cmax/MIC ratio of Capreomycin
Time frame: after day 8 of treatment
The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the maximum serum concentration, [Cmax/MIC], after administration of Capreomycin.
2 secondary outcomes
Volume of Distribution
Time frame: after day 8 of treatment
Clearance
Time frame: after day 8 of treatment
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 23 Jun 2014.
- Derived from this study: PubMed 28507117Van't Boveneind-Vrubleuskaya N, Seuruk T, van Hateren K, van der Laan T, Kosterink JGW, van der Werf TS, van Soolingen D, van den Hof S, Skrahina A, Alffenaar JC. Pharmacokinetics of Levofloxacin in Multidrug- and Extensively Drug-Resistant Tuberculosis Patients. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00343-17. doi: 10.1128/AAC.00343-17. Print 2017 Aug.
- Derived from this study: PubMed 28507113Velasquez AMA, Ribeiro WC, Venn V, Castelli S, Camargo MS, de Assis RP, de Souza RA, Ribeiro AR, Passalacqua TG, da Rosa JA, Baviera AM, Mauro AE, Desideri A, Almeida-Amaral EE, Graminha MAS. Efficacy of a Binuclear Cyclopalladated Compound Therapy for Cutaneous Leishmaniasis in the Murine Model of Infection with Leishmania amazonensis and Its Inhibitory Effect on Topoisomerase 1B. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00688-17. doi: 10.1128/AAC.00688-17. Print 2017 Aug.
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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.
JW C Alffenaar, PhD PharmD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by University Medical Center Groningen at 1 site in Belarus.
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 3 inclusion and 4 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 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. 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?
AUC/MIC ratio of Levofloxacin (time frame: after day 8 of treatment). The study lists 2 primary outcomes in all. 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 NCT02169141, which also lists 2 linked publications.
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 23 Jun 2014.