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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03000517 |
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Date of registration:
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01/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PK of Levofloxacin in MDR-TB Patients
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Scientific title:
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Pharmacokinetics of Levofloxacin in MDR-TB Patients |
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Date of first enrolment:
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May 4, 2016 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03000517 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Nepal
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Contacts
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Name:
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Jan-Willem Alffenaar |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Center Groningen, University of Groningen |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multi-drug Resistant Tuberculosis
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Primary Outcome(s)
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AUC
[Time Frame: Period I (15-30) day and Period II (45-60) day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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