Multi-drug Resistant TuberculosisNCT03000517
PK of Levofloxacin in MDR-TB Patients
An observational study of Multi-drug Resistant Tuberculosis, run by University Medical Center Groningen at 1 site in Nepal.
Trial summary
The emergence and spread of multi-drug resistant and extensively-drug resistant strains of Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-drug Resistant Tuberculosis
- How many people
- 20 participants
- Where
- 1 siteNepal
- Study dates
- 4 May 2016to 24 Jan 2018
- 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: Patient with previously treated or newly diagnosed MDR-TB who are at the end of first month(15-30th day) and second month (45-60th day) of their treatment.
Who may be able to join
- Patient with TB, with Mycobacterium tuberculosis by culture/ Gene Xpert
- Patient is 18 years or older with newly diagnosed or previously treated MDR-TB
- Patient with sputum smear positive for acid-fast bacilli or sputum smear negative but Gene Xpert (MTB/RIF) positive, and resistant to both isoniazid and rifampicin
- Patients with MDR-TB receiving levofloxacin as a part of MDR-TB regimen
Who cannot join
- Patient with neurologic or severe extra-pulmonary manifestations of tuberculosis
- Pregnant women or breast feeding mothers with MDR-TB
- Patients with diminished renal functions or on medications for the treatment of renal disorders
- Body weight <35 kg
- Patients treated with aluminium- and magnesium containing antacids and ferrous sulphates, cimetidine and probenecid, theophylline, warfarin, zidovudine, digoxin or cyclosporine.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
German Nepal Tuberculosis Project Clinic (GENETUP)
Kalimati, Kathmandu, 1494
About this study
Official title: Pharmacokinetics of Levofloxacin in MDR-TB Patients
The emergence and spread of multi-drug resistant and extensively-drug resistant strains of Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various factors contributing to the development of drug resistance, low drug exposure is well recognized. To overcome this, either new drugs have to be developed or the dose of currently used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired drug resistance to these drugs could complicate and narrow down the available options, and further exacerbate to pre-XDR and XDR-TB.
Objective:
Read more
The main objective of this prospective clinical study is to understand the pharmacokinetics of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body weight and correlate drug exposure, with treatment outcomes.
Study design:
A prospective pharmacokinetic study
Study population: 20 MDR-TB patients
Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on the body weight, under MDR-TB treatment regimen of Nepal.
Main study parameters/end points:
The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated in plasma and in oral fluid
- Conditions
- Multi-drug Resistant Tuberculosis
- Keywords
- levofloxacin, multi-drug resistant TB, pharmacokinetics
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
The main objective of this prospective clinical trial is to evaluate the levofloxacin exposures (AUC) of a standard dose (750-1250mg) in plasma and saliva of MDR-TB patients.
Measured: Period I (15-30) day and Period II (45-60) day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start4 May 2016
- Primary completion27 Oct 2017
- Study completion24 Jan 2018
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 Multi-drug Resistant 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
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, Principal investigator, University Medical Center Groningen, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000517
- Sponsor's protocol ID
- LFX/V0.1
- Status last verified
- Jan 2018
- First submitted
- 1 Sep 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghimire S, Maharjan B, Jongedijk EM, Kosterink JGW, Ghimire GR, Touw DJ, van der Werf TS, Shrestha B, Alffenaar JC. Evaluation of Saliva as a Potential Alternative Sampling Matrix for Therapeutic Drug Monitoring of Levofloxacin in Patients with Multidrug-Resistant Tuberculosis. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02379-18. doi: 10.1128/AAC.02379-18. Print 2019 May.
PubMed 30782999
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Levofloxacin in MDR-TB Patients
- ClinicalTrials.gov ID
- NCT03000517
- Acronym / sponsor ID
- LFX/V0.1
- Conditions
- Multi-drug Resistant Tuberculosis
- Keywords
- levofloxacin, multi-drug resistant TB, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 4 May 2016 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 22 Dec 2016 (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.
The emergence and spread of multi-drug resistant and extensively-drug resistant strains of Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various factors contributing to the development of drug resistance, low drug exposure is well recognized. To overcome this, either new drugs have to be developed or the dose of currently used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired drug resistance to these drugs could complicate and narrow down the available options, and further exacerbate to pre-XDR and XDR-TB.
Objective:
The main objective of this prospective clinical study is to understand the pharmacokinetics of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body weight and correlate drug exposure, with treatment outcomes.
Study design:
A prospective pharmacokinetic study
Study population: 20 MDR-TB patients
Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on the body weight, under MDR-TB treatment regimen of Nepal.
Main study parameters/end points:
The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated in plasma and in oral fluid
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with previously treated or newly diagnosed MDR-TB who are at the end of first month(15-30th day) and second month (45-60th day) of their treatment.
Key inclusion criteria (4 listed)
- Patient with TB, with Mycobacterium tuberculosis by culture/ Gene Xpert
- Patient is 18 years or older with newly diagnosed or previously treated MDR-TB
- Patient with sputum smear positive for acid-fast bacilli or sputum smear negative but Gene Xpert (MTB/RIF) positive, and resistant to both isoniazid and rifampicin
- Patients with MDR-TB receiving levofloxacin as a part of MDR-TB regimen
Key exclusion criteria (5 listed)
- Patient with neurologic or severe extra-pulmonary manifestations of tuberculosis
- Pregnant women or breast feeding mothers with MDR-TB
- Patients with diminished renal functions or on medications for the treatment of renal disorders
- Body weight <35 kg
- Patients treated with aluminium- and magnesium containing antacids and ferrous sulphates, cimetidine and probenecid, theophylline, warfarin, zidovudine, digoxin or cyclosporine.
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
AUC
Time frame: Period I (15-30) day and Period II (45-60) day
The main objective of this prospective clinical trial is to evaluate the levofloxacin exposures (AUC) of a standard dose (750-1250mg) in plasma and saliva of MDR-TB patients.
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 25 Jan 2018.
- Derived from this study: PubMed 30782999Ghimire S, Maharjan B, Jongedijk EM, Kosterink JGW, Ghimire GR, Touw DJ, van der Werf TS, Shrestha B, Alffenaar JC. Evaluation of Saliva as a Potential Alternative Sampling Matrix for Therapeutic Drug Monitoring of Levofloxacin in Patients with Multidrug-Resistant Tuberculosis. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02379-18. doi: 10.1128/AAC.02379-18. Print 2019 May.
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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.
Jan-Willem Alffenaar principal investigator
University Medical Center Groningen, University of 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 Multi-drug Resistant Tuberculosis, run by University Medical Center Groningen at 1 site in Nepal.
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 5 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 25 Jan 2018. 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 Nepal. 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 (time frame: Period I (15-30) day and Period II (45-60) day). 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 NCT03000517, 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 25 Jan 2018.