Immune Reconstitution in Tuberculosis Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Composite clinical TB score
研究概览
简要总结
The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV negative patients, adult patients >18 years who has not started anti-TB therapy.
- •Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 criteria for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment).
排除标准
- •Patients who have already started treatment with anti-TB drugs for more that 5 days.
- •HIV-positive patients.
- •History of anti-TB treatment in the past 2 years.
- •Local extra-pulmonary TB in the absence of lung manifestations.
- •Hypercalcaemia (serum calcium > 3 mmol/L) identified at baseline.
- •Pregnant and breast feeding women.
- •Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.
研究组 & 干预措施
vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.
干预措施: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate) (Drug)
Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
干预措施: Placebo tablets (Drug)
结局指标
主要结局
Composite clinical TB score
时间窗: 0 (baseline) compared to 8 weeks.
A previously described composite clinical TB score will be used to monitor the efficacy of vitamin D and phenylbutyrate treatment among TB patients on standard chemotherapy. The numerical TB score will include self-reported clinical symptoms (cough, night sweats and chest pain) as well as different parameters determined upon clinical examination anemia, haemoptysis, dyspnoea, tachycardia, positive finding at lung auscultation, fever, low body mass index (BMI) and low mid upper arm circumference (MUAC). The TB score will be determined at the time of diagnosis (time point 0) and at 4, 8, 16 and 24 weeks after initiation of antimicrobial treatment with vitamin D and phenylbutyrate. The primary endpoint will be assessed at time point 8 weeks compared to baseline (time point 0).
次要结局
- Laboratory secondary endpoints(0, 4, 8, 16, 24 weeks)
- Clinical secondary endpoints(0-4, 8, 16 and 24 weeks)
研究者
Susanna Brighenti
Associate professor
Karolinska Institutet