Study comparing anti-tuberculosis drug levels in saliva, plasma, and urine in patients

Not Applicable

• Conditions: Tuberculosis; Infection - Other infectious diseases

• Registration Number: ACTRN12623001088639
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-17
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified