Comparison of Anti-tuberculous Drug Levels in Diabetic and Non-diabetic Tuberculosis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 主要终点
- TB medication levels
研究概览
简要总结
This study compares blood levels of tuberculosis medications between diabetic patients and non-diabetic patients. There is some research that suggests these medications are at lower levels in diabetic patients with tuberculosis, and this could adversely affect the outcome of their infection. Diabetic patients are at higher risk of dying or having a severe episode of tuberculosis therefore it is important that their care is optimised as far as possible.
To answer the research question all participants in the study will have an extra blood sample drawn at the same time as their routine blood tests which are used to monitor their tuberculosis treatment. Some participants will have additional blood samples taken at different times to give a more accurate picture of the medication levels in their bloodstream. The study will be conducted in the tuberculosis clinics at London North West University Healthcare NHS Trust and will include adult patients with and without diabetes who have recently been diagnosed with tuberculosis.
Some other information about their routine medications, weight and height, and severity of diabetes will also be collected, to see if these affect the medication levels in the bloodstream as well.
详细描述
This is a case-controlled study measuring tuberculosis medication levels in diabetic and non-diabetic patients on treatment for tuberculosis.
Case:
Our tuberculosis clinic checks the levels of glycosalated haemoglobin (HbA1c), a marker of diabetes, in all patients with a new diagnosis of tuberculosis before they start treatment. All patients who are either known to have diabetes or have a raised HbA1c level will be identified at their clinic appointment. Patients who have a raised HbA1c and are not known to have diabetes will have a repeat blood test to confirm the result as part of normal clinical practice. If their level is still raised or they are known to have diabetes they will be asked if they wish to participate in the study.
They will be provided with a patient information leaflet and given the opportunity to ask questions, and discuss with friends and family if preferred.
If they agree to participate their tuberculosis care will continue as usual. Part of the standard care for our TB patients is to have blood tests at 2 weeks, 4 weeks and 8 weeks after starting treatment, to check for toxicity from the medications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged 18 years of age or over
- •Written, informed consent obtained.
- •New diagnosis of tuberculosis and started on anti-tuberculosis treatment Cases: Known diagnosis of diabetes or two consecutive raised IFCC HbA1c levels (>= 48 mmol/mol) at the time of TB diagnosis Controls: IFCC HbA1c level < 48mmol/mol
排除标准
- •Subject aged under 18 years
- •Inability to give informed consent
- •Repeat HbA1c level <48mmol/mol
结局指标
主要结局
TB medication levels
时间窗: 2 hours following medication dose
Comparison of 2-hour post-dose levels of anti-tuberculosis medications
次要结局
未报告次要终点