A prospective, randomized pilot study of the immunomodulatory effects of azithromycin in adults with pulmonary tuberculosis - AZT_DSTB_BB

niversitair Medisch Centrum Groningen0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- Microbiological proven diagnosis of drug sensitive pulmonary tuberculosis (by culture and/or molecular test.; absence of resistance genes such as rpob, inha, katg)
•- Written informed consent

•- Patient reported previous history of treatment for tuberculosis
•- Patients younger than 18 years
•- Pregnancy or breast feeding
•- Patients with hypersensitivity to macrolide antibiotics
•- Treatment with any macrolide in the previous month
•- Treatment with any tetracycline in the previous month
•- Treatment with any inhaled or oral corticosteroid in the previous month
•- Concomitant treatment with analgesic (NSAIDs)/immunosuppressant drugs (except paracetamol). See attachment A for a full list of these drugs.
•- Treatment with digoxin
•- Patients with gastrointestinal complaints, like diarrhea and vomiting (>=grade 2, observed; diarrhea: increase of 4-6 stools per day over baseline; vomiting: >=3-5 episodes (separated by 5 minutes) in 24 hours)
•- Other known respiratory diseases, including bronchiectasis, pulmonary fibrosis, pulmonary vascular disease or lung cancer
•- HIV-1 infection or AIDS
•- Impaired liver function (Child-Pugh score C, for calculation of the score, see attachment B)
•- Patients with a known QTc >=500 ms. An electrocardiogram (ECG) will be recorded.

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