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 sites30 target enrollmentOctober 17, 2023

Overview

No summary available.

Registry

who.int

Start Date

October 17, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.