acetyl cysteine therapy in patients with Pulmonary tuberculosis: A Pilot Open- Label Randomized controlled trial - NI

Dr Saurabh Mittal0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

暂无简介。

•1.Age 18 years or more.
•2.Willing to give written informed consent.
•3.Body weight = 30 kg.
•4.Pulmonary TB diagnosed with One sputum OR Bronchoalveolar lavage GeneXpert test positive.
•5.No detection of Rifampicin resistance by GeneXpert/ LPA/ MGIT C/S.
•6.A chest radiograph abnormality consistent with tuberculosis.
•7.No prior history of ATT.
•8.Willing to undergo HIV serology testing.
•9.Agrees to use effective barrier contraception during the period of the study.
•10.Residing around the study site (AIIMS, Delhi).
•11.Express willingness to attend the treatment center for supervised treatment.
•12.Express willingness to adhere to the trial procedures and follow-up schedule.

•1.Clinically significant evidence of extrapulmonary TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis).
•2.Poor general condition as assessed by the study investigator.
•3.Renal dysfunction including (but not limited to) serum creatinine levels above the upper limit of the laboratory reference range (Serum creatinine >1.2 mg/dL or blood urea >43 mg/dL)
•4.Has clinical jaundice or hepatic impairment characterized by serum bilirubin level above 1.2 times upper limit of the laboratory reference range, or by alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) levels >3 times the upper limit of the laboratory reference range
•5.Diabetes mellitus or Psychiatric illness
•6.Serology positive for HBSAg Or Hepatitis C virus antibody Or HIV
•7.Pregnant or lactating females
•8.Has any condition (social or medical) which in the opinion of the investigator would make trial participation unreliable or unsafe
•9.Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
•10.Has a known allergy to any of the drugs proposed to be used in the trial regimen
•11.Has evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities.

发起方

Dr Saurabh Mittal