Pharmacokinetic study of minocycline in patients with pulmonary nontuberculous mycobacterial disease - MINO PK in NTM

Radboudumc0 个研究点目标入组 12 人开始时间: 2021年4月8日最近更新: 2021年4月26日

适应症

试验速览

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•- ATS diagnostic criteria for NTM-PD are met, i.e. the patient is symptomatic, has nodules, bronchiectasis or fibro-cavitary lesions seen on (HR)CT scan of the lungs and =2 positive sputum cultures or one positive BAL culture of the same M. avium complex species.
•- The subject is eligible to start the guideline-recommended rifampicin-based regimen according to the treating physician.
•- At least one of the positive cultures must be done in the last 4 months before inclusion.
•- Age = 18 years.
•- Signed and dated patient 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 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•- A relevant medical history or current condition that might interfere with drug absorption, distribution, metabolism or excretion (i.e. chronic gastro-intestinal disease, renal or hepatic disease).
•- Diagnosed with cystic fibrosis (as this may affect the pharmacokinetics of drugs).
•- Pregnant or breastfeeding (contra-indications for minocycline) or inadequate contraceptive measures (in view of the administration of rifampicin which interacts with oral contraceptive drugs).
•- Use of drugs that cause a relevant drug interaction with minocycline, i.e. oral magnesium, bismuth, aluminium, calcium, zinc or iron containing formulations (antacid drugs, multivitamin and mineral-containing drugs) and other drugs besides rifampicin that induce metabolic enzymes, including but not limited to barbiturates, carbamazepin and phenytoin. The investigators refer to the ‘Flockhart’table for check of presence of possible inducers (https://drug-interactions.medicine.iu.edu/Main-Table.aspx).
•- ALAT > 3 times the upper limit of normal (normal <45 U/l).
•- ASAT > 3 times the upper limit of normal (normal <35 U/l).
•- An abnormal serum creatinine level (defined as a level that is higher than the upper limit of normal, i.e. >110 umol/l).
•- Active alcohol abuse.
•- Hypersensitivity to minocycline or to other tetracycline antibiotics.

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