Multi-drug Resistant Tuberculosis Clinical Trial
Official title:
Pharmacokinetics of Levofloxacin in MDR-TB Patients
Verified date | January 2018 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 20 |
Est. completion date | January 24, 2018 |
Est. primary completion date | October 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Nepal | German Nepal Tuberculosis Project Clinic (GENETUP) | Kalimati | Kathmandu |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Nepal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Period I (15-30) day and Period II (45-60) day |
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