Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study
BackgroundFungal infections are now a great public health threat, especially in those with underlying risk factors such as neutropenia, diabetes, high-dose steroid treatment, cancer chemotherapy, prolonged intensive care unit stay, and so on, which can lead to mycoses with hi...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2024-02-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2024/1/e54672 |
| _version_ | 1827348865885405184 |
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| author | Anup Kumar Ojha Venencia Albert Saurabh Sharma Vinaykumar Hallur Gagandeep Singh Umabala Pamidimukkala Kh Jitenkumar Singh Harleen Kaur Tadepalli Karuna Jayanthi Savio Reema Nath Immaculata Xess Prashant Gupta Anjali Shetty Madhuchhanda Das |
| author_facet | Anup Kumar Ojha Venencia Albert Saurabh Sharma Vinaykumar Hallur Gagandeep Singh Umabala Pamidimukkala Kh Jitenkumar Singh Harleen Kaur Tadepalli Karuna Jayanthi Savio Reema Nath Immaculata Xess Prashant Gupta Anjali Shetty Madhuchhanda Das |
| author_sort | Anup Kumar Ojha |
| collection | DOAJ |
| description |
BackgroundFungal infections are now a great public health threat, especially in those with underlying risk factors such as neutropenia, diabetes, high-dose steroid treatment, cancer chemotherapy, prolonged intensive care unit stay, and so on, which can lead to mycoses with higher mortality rates. The rates of these infections have been steadily increasing over the past 2 decades due to the increasing population of patients who are immunocompromised. However, the data regarding the exact burden of such infection are still not available from India. Therefore, this registry was initiated to collate systematic data on invasive fungal infections (IFIs) across the country.
ObjectiveThe primary aim of this study is to create a multicenter digital clinical registry and monitor trends of IFIs and emerging fungal diseases, as well as early signals of any potential fungal outbreak in any region. The registry will also capture information on the antifungal resistance patterns and the contribution of fungal infections on overall morbidity and inpatient mortality across various conditions.
MethodsThis multicenter, prospective, noninterventional observational study will be conducted by the Indian Council of Medical Research through a web-based data collection method from 8 Advanced Mycology Diagnostic and Research Centers across the country. Data on age, gender, clinical signs and symptoms, date of admission, date of discharge or death, diagnostic tests performed, identified pathogen details, antifungal susceptibility testing, outcome, and so on will be obtained from hospital records. Descriptive and multivariate statistical methods will be applied to investigate clinical manifestations, risk variables, and treatment outcomes.
ResultsThese Advanced Mycology Diagnostic and Research Centers are expected to find the hidden cases of fungal infections in the intensive care unit setting. The study will facilitate the enhancement of the precision of fungal infection diagnosis and prompt treatment modalities in response to antifungal drug sensitivity tests. This registry will improve our understanding of IFIs, support evidence-based clinical decision-making ability, and encourage public health policies and actions.
ConclusionsFungal diseases are a neglected public health problem. Fewer diagnostic facilities, scanty published data, and increased vulnerable patient groups make the situation worse. This is the first systematic clinical registry of IFIs in India. Data generated from this registry will increase our understanding related to the diagnosis, treatment, and prevention of fungal diseases in India by addressing pertinent gaps in mycology. This initiative will ensure a visible impact on public health in the country.
International Registered Report Identifier (IRRID)DERR1-10.2196/54672 |
| first_indexed | 2024-03-08T00:18:58Z |
| format | Article |
| id | doaj.art-561f0059024f4596a65829f520bc06ec |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-08T00:18:58Z |
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| series | JMIR Research Protocols |
| spelling | doaj.art-561f0059024f4596a65829f520bc06ec2024-02-16T13:30:32ZengJMIR PublicationsJMIR Research Protocols1929-07482024-02-0113e5467210.2196/54672Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective StudyAnup Kumar Ojhahttps://orcid.org/0000-0003-4688-3315Venencia Alberthttps://orcid.org/0000-0001-9736-8319Saurabh Sharmahttps://orcid.org/0000-0001-6744-5846Vinaykumar Hallurhttps://orcid.org/0000-0002-1001-7717Gagandeep Singhhttps://orcid.org/0000-0002-3169-8419Umabala Pamidimukkalahttps://orcid.org/0000-0002-5562-457XKh Jitenkumar Singhhttps://orcid.org/0000-0002-8823-5028Harleen Kaurhttps://orcid.org/0009-0000-5174-5430Tadepalli Karunahttps://orcid.org/0000-0002-5101-2541Jayanthi Saviohttps://orcid.org/0000-0001-5172-4058Reema Nathhttps://orcid.org/0009-0000-5943-2084Immaculata Xesshttps://orcid.org/0000-0002-6218-2175Prashant Guptahttps://orcid.org/0000-0002-6925-3546Anjali Shettyhttps://orcid.org/0000-0001-9575-4080Madhuchhanda Dashttps://orcid.org/0009-0004-3024-4118 BackgroundFungal infections are now a great public health threat, especially in those with underlying risk factors such as neutropenia, diabetes, high-dose steroid treatment, cancer chemotherapy, prolonged intensive care unit stay, and so on, which can lead to mycoses with higher mortality rates. The rates of these infections have been steadily increasing over the past 2 decades due to the increasing population of patients who are immunocompromised. However, the data regarding the exact burden of such infection are still not available from India. Therefore, this registry was initiated to collate systematic data on invasive fungal infections (IFIs) across the country. ObjectiveThe primary aim of this study is to create a multicenter digital clinical registry and monitor trends of IFIs and emerging fungal diseases, as well as early signals of any potential fungal outbreak in any region. The registry will also capture information on the antifungal resistance patterns and the contribution of fungal infections on overall morbidity and inpatient mortality across various conditions. MethodsThis multicenter, prospective, noninterventional observational study will be conducted by the Indian Council of Medical Research through a web-based data collection method from 8 Advanced Mycology Diagnostic and Research Centers across the country. Data on age, gender, clinical signs and symptoms, date of admission, date of discharge or death, diagnostic tests performed, identified pathogen details, antifungal susceptibility testing, outcome, and so on will be obtained from hospital records. Descriptive and multivariate statistical methods will be applied to investigate clinical manifestations, risk variables, and treatment outcomes. ResultsThese Advanced Mycology Diagnostic and Research Centers are expected to find the hidden cases of fungal infections in the intensive care unit setting. The study will facilitate the enhancement of the precision of fungal infection diagnosis and prompt treatment modalities in response to antifungal drug sensitivity tests. This registry will improve our understanding of IFIs, support evidence-based clinical decision-making ability, and encourage public health policies and actions. ConclusionsFungal diseases are a neglected public health problem. Fewer diagnostic facilities, scanty published data, and increased vulnerable patient groups make the situation worse. This is the first systematic clinical registry of IFIs in India. Data generated from this registry will increase our understanding related to the diagnosis, treatment, and prevention of fungal diseases in India by addressing pertinent gaps in mycology. This initiative will ensure a visible impact on public health in the country. International Registered Report Identifier (IRRID)DERR1-10.2196/54672https://www.researchprotocols.org/2024/1/e54672 |
| spellingShingle | Anup Kumar Ojha Venencia Albert Saurabh Sharma Vinaykumar Hallur Gagandeep Singh Umabala Pamidimukkala Kh Jitenkumar Singh Harleen Kaur Tadepalli Karuna Jayanthi Savio Reema Nath Immaculata Xess Prashant Gupta Anjali Shetty Madhuchhanda Das Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study JMIR Research Protocols |
| title | Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study |
| title_full | Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study |
| title_fullStr | Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study |
| title_full_unstemmed | Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study |
| title_short | Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study |
| title_sort | pan indian clinical registry of invasive fungal infections among patients in the intensive care unit protocol for a multicentric prospective study |
| url | https://www.researchprotocols.org/2024/1/e54672 |
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