Prospective Pharmacokinetic study to evaluate the correlation between isoniazid (incl NAT2 genotyping), rifampicin, pyrazinamide, ethambutol and levofloxacin drug concentration in saliva, plasma and urine in patients with drug susceptible tuberculosis (TB)

Western Sydney Local Health District0 个研究点目标入组 30 人开始时间: 2023年10月17日最近更新: 2023年10月23日

适应症

试验速览

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•Patients 18 years old or older
•-Diagnosis of bacteriologically confirmed active pulmonary and/or extrapulmonary drug-susceptible TB.
•-Started treatment with a standard-of-care regimen containing isoniazid, rifampicin, pyrazinamide and ethambutol.
•-Provided informed consent for this study.

•-Patients who avoid levofloxacin or with contra-indications for levofloxacin including:
•hypersensitivity to fluoroquinolones
•patients with known aortic aneurysm or Marfan's syndrome
•agranulocytosis (absolute neutrophil count < 500 cells/mm³)
•thrombocytopenia (count below 50,000 platelets /mm³)
•myasthenia gravis
•renal function loss (creatinine clearance <50ml/min)
•hepatic dysfunction (aspartate aminotransferase and or alanine aminotransferase > 3 times upper level of normal).
•-Patients with bleeding mucositis or ulcers which will not allow saliva collection.
•-Patients with recently proven C.difficile infection.

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