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临床试验/CTRI/2024/11/076306
CTRI/2024/11/076306尚未招募不适用

Therapeutic Drug Monitoring and Estimation of Undernutrition among Adult Household Contacts of TB Patients on TB Preventive Treatment

BLDE deemed to be university1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2024年11月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
196
试验地点
1
主要终点
Therapeutic drug levels among individuals on TB Preventive treatment

研究概览

简要总结

TB preventive treatment (TPT) is an effective and cost-effective intervention to prevent progression from infection to disease and to reduce mortality due to TB.The TPT with isoniazid in countries like India currently covers only select groups of contacts like children under 6 years of age and people living with HIV. WHO recently made a conditional recommendation of offering TPT to all household contacts (HHC) i.e, any person residing in the same household as a TB patient of all ages. The burden of TB infection is the highest among household contacts. Apart from being the largest burden of cases and deaths related to tuberculosis, India also has undernutrition as leading risk factor accounting for TB incidence and, undernutrition is a major common risk factor for mortality in patients with TB in India. The relationship between TB and nutrition is bidirectional, i.e. having active TB leads to loss of weight, and being underweight is considered a risk factor for developing TB, whether through reactivation of latent TB or developing progressive primary disease upon infection. A systematic review of literature showed that across a variety of settings with different levels of TB burden, a strong and consistent log-linear relationship existed between BMI and TB incidence - for each unit reduction in BMI the risk of TB increased by about 14 per cent. Different pathophysiological conditions in undernutrition/malnutrition can alter the pharmacokinetics of drugs. Gastrointestinal changes include hypochlorhydria, delayed gastrointestinal emptying time, increased or decreased intestinal transit time, gastric and mucosal atrophy and dysfunction, gastrointestinal inflammation, and pancreatic insufficiency. In the enterocytes, P-glycoprotein activity is decreased and tight junctions are enlarged, influencing the uptake of nutrients and drugs. This pharmacokinetic variability is one of the main causes for sub-optimal therapeutic drug concentration. 

Hence Therapeutic drug monitoring is one of the best tools, to asses optimum drug concentration in such conditions. Undernourishment leads to various micro and micronutrition deficiency leading to alteration in the pharmacokinetic properties which in tent leads to decreased therapeutic efficacy of drug taken for TB preventive treatment.  As HHC are at high risk of developing the disease and importance of nutrition in TB is well established. It is important to estimate optimum drug therapy through Therapeutic drug monitoring and also estimate undernutrition among the adult household contacts of TB patients put on TB preventive treatment to prevent infection to disease progression.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All adult aged more than 18years and are household contacts of TB patients put on TB preventive treatment of Drug sensitive TB patients.

排除标准

  • People leaving with HIV on TB preventive treatment and Pregnant and lactation mothers on TB preventive treatment.

结局指标

主要结局

Therapeutic drug levels among individuals on TB Preventive treatment

时间窗: After two hours of drug administration

次要结局

  • Prevalence of undernutrition among individuals on TB preventive treatment(After two hours of drug administration)

研究者

发起方
BLDE deemed to be university
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Latha S

Department of Pharmacology BLDE DU(s) shri B M Patil Medical College Hospital and research center

研究点 (1)

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