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

niversity Medical Center Groningen0 个研究点目标入组 24 人开始时间: 2017年8月24日最近更新: 2024年4月22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:
•-Clinical diagnosis of drug sensitive pulmonary tuberculosis (molecular test; identification Mtb complex; absence of resistance genes such as rpob, inha, katg)
•-Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A potential subject who meets any of the following criteria will be excluded from participation in this study (most of these criteria are recorded as standard of care):
•-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)
•-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)
•-Patients with a known QTc =500 ms. An electrocardiogram (ECG) will be recorded.
•-Inability to spontaneously produce sputum upon diagnosis

发起方