跳至主要内容
临床试验/CTRI/2023/11/060346
CTRI/2023/11/060346已完成不适用

Improved data on Dengue covering differences in epidemiological surveillance, patient demographics, the health seeking behavior of patients and standards of care

Drugs for Neglected Diseases Initiative South Asia Pvt. Ltd3 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2023年12月8日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
316
试验地点
3
主要终点
To collect data on dengue covering differences in epidemiological data, patient demographics, the health seeking behavior of patients and standards of care across different regions in India

研究概览

简要总结

This Observational multicentric study has been planned to address the dengue related knowledge gaps by collecting data covering differences in epidemiological surveillance, patient demographics, the health seeking behavior of patients and standards of care for dengue across different clinical sites in India. The study has been planned in 2 parts.

 

Study Objectives:

Part A

  1. To determine the number of patients with dengue fever admitted to one or more hospitals in

India during a period of 3 months or more if sample size requirements are not met

  1. To characterize the age, gender, clinical features, complications and clinical disease severity of patients with acute dengue presenting to healthcare facilities in India.

  2. To determine the proportion of admitted patients with acute dengue who have comorbidities

(diabetes, obesity, hypertension, sickle cell disease)

  1. To determine the proportion of admitted patients with dengue that required admission to intensive care units and the reasons for the same along with associated mortality.

  2. To determine the duration of hospital stay in patients admitted to a hospital with acute dengue

 

Part B

  1. To determine the number of patients with suspected acute dengue presenting to a primary health care facility/outpatient facility/community centers/other health care settings in India in a three-month period (extendable if required) between October 2023 to May 2024.

  2. To characterize the age, gender, clinical features, complications and clinical disease severity of patients with suspected acute dengue presenting at these sites

  3. To identify the duration of illness when seeking medical advice and reasons for presenting late/early

  4. To determine the knowledge about dengue warning signs and risk factors for severe disease (diabetes, obesity, pregnancy, old age etc.)

  5. To find out the type of treatment taken prior to seeking medical advice (herbal remedies, paracetamol, NSAIDs and other OTCs)

 

Methodology

Part A: All patients who are hospitalized with acute dengue and who are capable of participating and providing consent will be recruited following informed written consent. The study will be carried out in 3 tertiary care hospitals in India.

 

Part B: Patients with a febrile illness and suspected to have acute dengue will be recruited in 2-3 PHC/CHC/UHTC/RHTC associated with the tertiary care hospitals participating in Part A of the study. Also, the study will be conducted in the OPDs of the selected tertiary care hospitals in Part A of the study proposal. The patients will be recruited following informed written consent.

A pre-tested and structured interviewer-administered questionnaire will be used to record requisite patient related details. Complete patient data confidentiality will be maintained.

A validated data management tool will be used to collect all patient-related information. Descriptive statistics will be used to analyze subject data.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Part A All patients who are hospitalized with a suspected/confirmed acute dengue and who are capable of participating and providing consent will be recruited following informed written consent Part B Patients with a febrile illness and suspected to have acute dengue presenting to a primary health care facility OR outpatient facility OR community center of the study sites who are capable of participating and providing consent will be recruited following informed written consent.

排除标准

  • Part A Patient refusal to participate Part B Patient refusal to participate.

结局指标

主要结局

To collect data on dengue covering differences in epidemiological data, patient demographics, the health seeking behavior of patients and standards of care across different regions in India

时间窗: Part A | Data collection at the time when a dengue patient admitted to the hospital is recruited in the study and subsequently at discharge | Part B | Data collection at a single time point when febrile patient with suspected dengue presents to the OPD or the primary health centre and is enrolled in the study

次要结局

未报告次要终点

研究者

发起方
Drugs for Neglected Diseases Initiative South Asia Pvt. Ltd
申办方类型
Other [Industry partner]
责任方
Principal Investigator
主要研究者

Dr Kavita Singh

DNDi South Asia Pvt. Ltd

研究点 (3)

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