Mortality and severity predictors of Leptospirosis and usefulness of SPiRO score.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- To identify clinical predictors of disease severity and mortality in Leptospirosis.
研究概览
简要总结
This study is being performed to explore a set of parameters for predicting severe leptospirosis in adult patients
Objectives are as follows
To identify clinical predictors of disease severity and mortality in Leptospirosis
To evaluate the prognostic utility of the Spiro Score in predicting disease severity and mortality in leptospirosis
Analyze patient outcomes based on SPiRO Score categories to determine its practical usefulness
Patients aged 18 years and above with suspected, probable, or confirmed leptospirosis will be recruited from OPD and IPD settings between June 2025 and June 2027.Recruitment will follow eligibility screening based on inclusion and exclusion criteria, with informed consent obtained before enrolment. Initial assessment includes demographic data, clinical history, vital signs, and laboratory tests completed within 24 hours of admission.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 years and above 2) Patients diagnosed with suspected, probable or confirmed leptospirosis based on WHO 2003 diagnostic criteria.
- •Hospitalized patients (those admitted for treatment and management of leptospirosis- related complications) 4) Availability of laboratory and clinical data, including parameters such as presence of Jaundice, Hemoptysis, Hypotension, Hematocrit levels, WBC count and platelet count.
排除标准
- •Co-Infections – Patients with other infectious diseases that may affect prognosis (e.g., dengue, malaria).
- •Age – Below 18 years not included.
- •Clinical and Laboratory Data – Cases lacking sufficient clinical or laboratory data.
- •Pre-existing Medical Conditions – Patients with thalassemia, chronic kidney disease, or other serious underlying conditions.
- •Patients on Immunosuppressive Therapy – Those undergoing chemotherapy or immunosuppressive treatments that may alter the disease presentation.
结局指标
主要结局
To identify clinical predictors of disease severity and mortality in Leptospirosis.
时间窗: 4 weeks
次要结局
- 1) To evaluate the prognostic utility of the Spiro Score in predicting disease severity & mortality in leptospirosis.(2) Analyze patient outcomes based on SPiRO Score categories to determine its practical usefulness.)
研究者
Sriti Lakhotia
Kasturba Medical College, Manipal