Evaluation of host immune responses and parasite proteome in patients with severe/complicated malaria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Serum proteome analysis of patients suffering from severe P vivax and P falciparum malaria infections to get mechnistic insights about disease pathogenesis and host immune response
研究概览
简要总结
Malaria is amajor health problem in Asia and Africa and to date more than 1 million peopledie annually due to this diseaseLack of early diagnosis effectivevaccines as well as drug resistance remains major challenges The incidence ofmalaria from P vivax and P falciparum speciesof the malaria parasite and its complications is on the rise worldwide withreports of mortality from what was thought to be an otherwise benign parasite Proteomic investigations of the P vivaxand P falciparum along with the studyof host immune responses may significantly advance our understanding andperhaps aid prognosis
Thisproject aims to perform a comprehensive proteomic analysis of serum samples ofsevere P falciparum malaria and P vivax malaria patients admitted in Departmentof Clinical Pharmacology Seth GS Medical College and KEM Hospital We will perform thecomparative serum proteome analysis of and healthy controls severe andnon severe FM and VM malaria patients using 2DE and 2D DIGE in combination withMALDI TOF/TOF MS to decipher disease pathogenesis host immune response andidentification of surrogate protein markers Proteomic andimmunoassay based analysis of the clinical samples will be performed at Departmentof Biosciences and Bioengineering Indian Institute of Technology Bombay Powai Mumbai 400 076 India Diagnostic impact of identified serum biomarkers inclinics and specificity for malaria prediction will be established byinvestigation of the disease patterns in large clinical cohorts usingimmunoassay-based analysis Panel of identified biomarkers will be tested toevaluate their efficiency in diagnosis. Expression levels of the identifiedserum protein in severe malaria patients will help to correlate the identifiedmarker proteins with disease severity and evaluate the prognostic value of thetarget proteins Specificity of the identified malaria related serum markers willbe evaluated by means of analysis of dengue fever and leptospirosis as febrilecontrols
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of either sex aged 18 to 65 years both inclusive Either gender with a diagnosis of severe/complicated vivax malaria OR with a diagnosis of severe malaria due to mixed infection Confirmed nonmalaria fever patients dengue fever (serum IgM antibody titre) leptospirosis (microscopic agglutination test)and enteric fever (widal test) Healthy volunteers as judged by medical history clinical examination and laboratory investigations Patients or their legally accepted representatives willing to provide written informed consent.
排除标准
- •Patients with history of significant systematic disease like autoimmune disorders chronic liver diseases psychiatric illness and bleeding disorders etc As judged by history and physical examination Patients with a diagnosis of complications to dengue leptospirosis or any other infectious disease A female patient who is pregnant at enrolling.
结局指标
主要结局
Serum proteome analysis of patients suffering from severe P vivax and P falciparum malaria infections to get mechnistic insights about disease pathogenesis and host immune response
时间窗: single time
Identification of potential serum markers associated with severe versus uncomplicated malaria
时间窗: single time
Correlation of the identified serum markers with disease severity establishment of prognostic host markers of malaria
时间窗: single time
次要结局
未报告次要终点