Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103331
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-10-23
Brief Title:
Fungal Surveillance in Bangladesh
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
Surveillance for Invasive Fungal Infections in Selected Hospitals in Dhaka City Bangladesh
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be an exploratory descriptive study designed to conduct surveillance for the identification of invasive fungal pathogens among hospitalized patients in Bangladesh at two tertiary care acute-level hospitals including the Dhaka Medical College Hospital the Dhaka Hospital of icddrb and the National Institute of Cancer Research Hospital NICRH Respiratory samples blood urine cerebrospinal fluid surgical wound infection swabs and other samples including biopsy tissue specimens will be obtained at intensive care units general medicine and surgery wards post-operative care etc The collected specimens will be sent to the clinical microbiology laboratories of the surveillance hospitals or to the pathology laboratory biopsy tissue specimens to test for Aspergillus Histoplasms Candida Pneumocystis Cryptococcus and Mucormycetes The lab methods will include microscopy staining culture and biochemical tests mainly and if feasible then some specimens may undergo molecular or immunological methods
Detailed Description:
1 Burden
Over 300 million people worldwide are infected with a deadly fungal infection with 25 million at high risk of death or blindness Population and disease demographics are used to calculate the worldwide burden of fungal diseases age gender HIV infection asthma etc
Given the growing number of immunocompromised individuals especially among hospitalized patients who are at increased risk for invasive fungal infections fungal illnesses require more attention than ever before The importance of fungal diseases contributing to worldwide morbidity and mortality is emphasized To assess the burden of these diseases more precisely long-term sustainable monitoring systems for fungal diseases as well as better noninvasive and reliable diagnostic methods are required
Even though most deaths from fungal illnesses are preventable they are still a neglected topic by public health authorities Other health issues such as asthma AIDS cancer organ transplantation and corticosteroid therapy can result in serious fungal infections Antifungal therapy can be started right away if a correct diagnosis is made early Recent global estimates have found 3000000 cases of chronic pulmonary aspergillosis 223100 cases of cryptococcal meningitis complicating HIVAIDS 700000 cases of invasive candidiasis 500000 cases of Pneumocystis jirovecii pneumonia 250000 cases of invasive aspergillosis 100000 cases of disseminated histoplasmosis over 10000000 cases of fungal asthma and 1000000 cases of fungal keratitis occur annually
2 Knowledge gap
Currently there is no ongoing national surveillance system to detect invasive fungal pathogens or serious health threats Hence there is inadequate data on the burden types and diversity of fungal species in particular among hospitalized patients in Bangladesh Some noteworthy issues affecting the proper diagnosis of invasive fungal pathogens in Bangladesh are an inadequate number of trained laboratory personnel to diagnose fungal diseases only a few healthcare facilities performing fungal culture insufficient awareness about severe fungal infections lack of prioritization for fungal disease surveillance in healthcare delivery lack of understanding about utilization of surveillance data to guide diagnosis and treatment lack of antifungal drug stewardship and diagnostic stewardship and significant logistical challenges to ensure adequate biosecurity for diagnosis of and prevention against severe fungal infections
Relevance
Investigators need to take the necessary steps that will gradually lead to the establishment of a national surveillance system for invasive fungal pathogens increase the generation of country-representative fungal surveillance data improve surveillance data usage and reporting and enhance IPC activities in Bangladesh
Objectives
To identify hospitalized patients infected with invasive fungal pathogens
Description of the research project
Methods
This will be an exploratory descriptive study designed to conduct surveillance for the identification of invasive fungal pathogens among hospitalized patients in Bangladesh at two tertiary care acute-level hospitals
The primary outcomes to be measured in this study
The proportion of laboratory-identified invasive fungal pathogens among hospitalized patients
Over 300 million people worldwide are infected with a deadly fungal infection with 25 million at high risk of death or blindness Population and disease demographics are used to calculate the worldwide burden of fungal diseases age gender HIV infection asthma etc
Given the growing number of immunocompromised individuals especially among hospitalized patients who are at increased risk for invasive fungal infections fungal illnesses require more attention than ever before The importance of fungal diseases contributing to worldwide morbidity and mortality is emphasized To assess the burden of these diseases more precisely long-term sustainable monitoring systems for fungal diseases as well as better noninvasive and reliable diagnostic methods are required
Even though most deaths from fungal illnesses are preventable they are still a neglected topic by public health authorities Other health issues such as asthma AIDS cancer organ transplantation and corticosteroid therapy can result in serious fungal infections Antifungal therapy can be started right away if a correct diagnosis is made early Recent global estimates have found 3000000 cases of chronic pulmonary aspergillosis 223100 cases of cryptococcal meningitis complicating HIVAIDS 700000 cases of invasive candidiasis 500000 cases of Pneumocystis jirovecii pneumonia 250000 cases of invasive aspergillosis 100000 cases of disseminated histoplasmosis over 10000000 cases of fungal asthma and 1000000 cases of fungal keratitis occur annually
2 Knowledge gap
Currently there is no ongoing national surveillance system to detect invasive fungal pathogens or serious health threats Hence there is inadequate data on the burden types and diversity of fungal species in particular among hospitalized patients in Bangladesh Some noteworthy issues affecting the proper diagnosis of invasive fungal pathogens in Bangladesh are an inadequate number of trained laboratory personnel to diagnose fungal diseases only a few healthcare facilities performing fungal culture insufficient awareness about severe fungal infections lack of prioritization for fungal disease surveillance in healthcare delivery lack of understanding about utilization of surveillance data to guide diagnosis and treatment lack of antifungal drug stewardship and diagnostic stewardship and significant logistical challenges to ensure adequate biosecurity for diagnosis of and prevention against severe fungal infections
Relevance
Investigators need to take the necessary steps that will gradually lead to the establishment of a national surveillance system for invasive fungal pathogens increase the generation of country-representative fungal surveillance data improve surveillance data usage and reporting and enhance IPC activities in Bangladesh
Objectives
To identify hospitalized patients infected with invasive fungal pathogens
Description of the research project
Methods
This will be an exploratory descriptive study designed to conduct surveillance for the identification of invasive fungal pathogens among hospitalized patients in Bangladesh at two tertiary care acute-level hospitals
The primary outcomes to be measured in this study
The proportion of laboratory-identified invasive fungal pathogens among hospitalized patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None