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CTRI Number  CTRI/2024/04/065866 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Smart tool to diagnose tropical fevers  
Scientific Title of Study   Development and evaluation of diagnostic tool for differentiating tropical fevers using an artificial intelligence approach. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shravya C 
Designation  Phd Research Scholar 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9442894110  
Fax    
Email  shravya.c@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Girish Thunga 
Designation  Associate Professor 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Girish Thunga 
Designation  Associate Professor 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education, Manipal Udupi District, Karnataka 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shravya C  Kasturba Medical College, Manipal  Room no 23, Near TMA Pai Halls, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 
9448294110

shravya.c@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A920||Chikungunya virus disease, (2) ICD-10 Condition: A90||Dengue fever [classical dengue], (3) ICD-10 Condition: J09X||Influenza due to identified novelinfluenza A virus, (4) ICD-10 Condition: J118||Influenza due to unidentified influenza virus with other manifestations, (5) ICD-10 Condition: J118||Influenza due to unidentified influenza virus with other manifestations, (6) ICD-10 Condition: A279||Leptospirosis, unspecified, (7) ICD-10 Condition: B509||Plasmodium falciparum malaria, unspecified, (8) ICD-10 Condition: B529||Plasmodium malariae malaria without complication, (9) ICD-10 Condition: B519||Plasmodium vivax malaria without complication, (10) ICD-10 Condition: A010||Typhoid fever, (11) ICD-10 Condition: A753||Typhus fever due to Rickettsia tsutsugamushi,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients provisionally diagnosed with the tropical fever of interest with required clinical and laboratory parameters
 
 
ExclusionCriteria 
Details  Children, patients without confirmed diagnosis, mixed infections, patients on immunosuppressants, provisional and confirmed diagnosis with specific conditions like pneumonia, urinary tract infection, acute febrile disease due to sepsis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome of evaluation for AI-based diagnostic models performance is determined based on model performance metrics such as sensitivity, specificity, accuracy, kappa value, hamming loss, area under receiver operating characteristics   2 time points
Day of admission and after three days of admission 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The prevalence of tropical fevers, caused by various pathogens transmitted through vectors, contributes significantly to morbidity and mortality in tropical regions. Challenges exist in diagnosis due to overlapping clinical symptoms, false positive results of disease-specific tests, reliability of the tests, mixed infection. Additionally, these available tests are time-consuming and expensive. Consequently, there is growing interest among researchers to develop certain diagnostics which are simple, quick, easy to use and cheaper. In this regard, artificial intelligence emerges as a pivotal domain, facilitating advancements in disease prediction, mutation detection, pre-emption of next-generation viral diseases, and new drug development etc. Thus, our objective is to devise and assess a technology-integrated tool tailored for the diagnosis and differentiation of tropical fevers within tertiary care hospital settings.

In the present study, phase 1 involves the identification of tropical fevers and associated clinical parameters through a retrospective audit and qualitative interviews with physicians. The case definition includes criteria for acute febrile illness with overlapping symptoms such as fever, rashes, headache, cough, nausea, vomiting, jaundice, abdominal pain, diarrhoea, thrombocytopenia, encephalopathy, respiratory distress, and renal failure etc. Inclusion and exclusion criteria are established to select cases from medical records, excluding other infections such as pneumonia, sepsis, urinary tract infection have similar symptoms with confirmed diagnosis and immunocompromised patients. Consequently, a qualitative interview with physicians will be conducted to understand diagnostic challenges and the importance of clinical and demographical variables. Based on both of these stages of phase 1, the disease and the parameters required for the development of the diagnostic tool will be finalized.

This will be followed by phase 2 which mainly focuses on the construction of the model through retrospective study. Inclusion criteria specify patients aged 18-60 with confirmed diagnoses of tropical fevers, while exclusion criteria exclude children, mixed infections, and missing data. Data from 2019 to 2023 will be collected retrospectively and used in the development of the model. Python language will be used for model construction, employing machine learning techniques like SVM and logistic regression. Data preprocessing, feature selection, and optimization techniques will be applied, and performance metrics will evaluate model efficacy.

Once the model is developed, it will be implemented in the hospital setting in two stages. First part will involve feasibility study for assessing model performance in two hospital settings and calculating sensitivity and specificity to determine sample size for final evaluation. The second stage involves the single-centric observational study for the implementation of the model. Total of 400 patients will be enrolled after Inform consent and baseline demographical, and biochemical parameters will be collected from patient data sheet .The collected data will be used in predicting diagnoses through the developed model and predictions will be compared with specific confirmatory laboratory test results. Model performance will be assessed using various metrics such as Sensitivity, Specificity, Accuracy, Precision, F-measure, Kappa value, Hamming loss, and Area under receiver operating characteristic (AUROC), and overall model performance will be notified to the physicians.

 

 
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