| 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
|
|
|
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
|
|
|
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. |