Dataset of N-acetyl cysteine (NAC) Clinical Trial in Multi Drugs Resistance Tuberculosis Tanzania
Description
The Dataset was originated from the NAC trial, primary aim was to assess the development of clinical or laboratory-based or both adverse events at any frequency during the first six month of MDR-TB treatment MDRTB patients using NAC at a dose of 900mg daily or 900mg twice a day in combination with second line regimen and compare with patients using the standard based regimen. Other objectives include - To assess the effect of NAC at a dose of 900mg daily or 900mg twice a day on pharmacokinetics of second-line anti-TB drugs. - To assess safety and tolerability of patients on NAC at a dose of 900mg and 900 mg twice a day in combination of second line anti-TB regimen.
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Steps to reproduce
This study was 6 months randomized clinical trial of NAC at different dosages in combination with DR-TB patients between 2020 and April 2023 in 66 patients with DR-TB who fulfilled the eligibility criteria in Kibong’oto Infectious Diseases Hospital, Tanzania. The Inclusion criteria were age range from 18- 75, newly diagnosed MDR-TB without prior MDR-TB exposure, with a Karnofsky score of 50 or above, defined as individuals requiring less considerable or frequent medical care. Female participants should have a negative urinary pregnancy test. Kidney function should be < 2mg/dL creatinine or creatinine clearance level >30 ml/min per Cockcroft-gault Formular, hemoglobin > or 8 g/dL, platelets > or 100k/mm3, Liver function test < or 2X ULN, Chest X-ray compatible with TB, with normal baseline EKG. Patients were excluded if they were Critically ill, had Allergy or Hypersensitivity to NAC, CD4 count < 100 in HIV, had History of cardiac arrhythmias or QTc prolongation, Liver failure, Renal failure, were Pregnant, exposed to IV fungal medication within the last 90 days, had previous or existing brain pathology (Major head trauma, meningitis, encephalitis, metastasis, vestibular schwannoma). Patients who have participated in other clinical trials with investigational agents within eight weeks before enrolling in an investigational trial. Patients living with HIV that met the WHO clinical stage 4 HIV disease criteria.
Institutions
- Kibong'oto Infectious Diseases Hospital