Invasive Fungal InfectionsNCT06103331
Fungal Surveillance in Bangladesh
An observational study of Invasive Fungal Infections, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months and older
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Invasive Fungal disease surveillance
- How many people
- 800 participants
- Where
- 1 siteBangladesh
- Study dates
- 20 Jan 2022to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients meeting the inclusion criteria and having ONE of the following groups of clinical features suggestive of infection of a particular organ system during sample collection: * Clinical features suggestive of infection of the respiratory system: * Fever or chills WITH * Cough or shortness of breath WITH * Abnormal lung findings on chest auscultation or on chest X-ray or CT scans * Clinical features of sepsis: * Hyperthermia or hypothermia (rectal temperature >38.5 Celsius or <35 Celsius respectively) and tachycardia plus either bounding pulses or, altered mental status or, hypoxemia in absence of pneumonia or, abnormal WBC count (>12×109 ⁄ L or, <4 ×109 ⁄ L or, band and neutrophil ratio ≥ 0.1) or, increased serum lactate level (diagnosed by physicians)
Who may be able to join
- Must include all of the following criteria:
- Admitted/hospitalized patients of any age and gender in tertiary-level acute care hospitals AND
- Having any of the following co-morbid immunosuppressive conditions or risk factors for healthcare-associated fungal infections such as:
- Chronic lung conditions including asthma, COPD
- Hemodialysis patients,
- diabetes,
Show all 24Show fewer
- Patients receiving chemotherapy or immunosuppressive drugs (e.g. corticosteroids, immunosuppressive drugs among organ transplant recipients), for ≥7 days
- Patients with AIDS
- Patients at risk of healthcare-associated infections (e.g., Patients under postoperative care, having a urinary catheter, with tracheal intubation, under ventilatory support, secured with intravenous (IV) cannula, any other invasive procedures, etc.)
- Hospitalized Patients under prolonged injectable antibiotic treatment (>7 days)
- Prolonged hospitalization more than 7 days.
- History of taking steroids or antibiotics for more than 2 weeks prior to hospitalization
- AND
- Patients or caregivers providing consent
- For children aged <5 years, the age criteria and additional inclusion criteria will be as follows:
- 0 to 59-month-old children of either sex admitted in hospital with any illness.
- Have features of sepsis/pneumonia (based on clinical features below)
- And any of the following criteria:
- Those who will fail to respond to injectable antibiotics or both 1st and 2nd line antibiotics (1st line- inj. Ampicillin plus gentamicin, 2nd line- inj. Ceftriaxone plus levofloxacin/gentamicin as per icddr,b hospital protocol)
- Any child with SAM or h/o recent measles or any condition that may induce immune suppression plus fail to respond to injectable antibiotics/ 1st line antibiotics (1st line antibiotics- inj. Ampicillin +inj. Gentamicin)
- Those who will develop late-onset hospital-associated infection (LOHAI)
- Any child who will require ICU care for more than 7 days
- Develop extensive thrush after taking long-term injectable antibiotics
- History of taking steroids or antibiotics for more than 2 weeks prior to hospitalization
Who cannot join
- History of taking antifungal drugs within 2 weeks
- Not willing to give consent
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
International Centre for Diarrheal Disease Research, Bangladesh (icddr,b)
Dhaka, 1212
Sayeeda Huq, MBBS,MIPH, +8801678127723, sayeeda@icddrb.org
About this study
Official title: Surveillance for Invasive Fungal Infections in Selected Hospitals in Dhaka City, Bangladesh
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 icddr,b, 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.
Read the detailed description
- 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 3,000,000 cases of chronic pulmonary aspergillosis, ~223,100 cases of cryptococcal meningitis complicating HIV/AIDS, ~700,000 cases of invasive candidiasis, ~500,000 cases of Pneumocystis jirovecii pneumonia, ~250,000 cases of invasive aspergillosis, ~100,000 cases of disseminated histoplasmosis, over 10,000,000 cases of fungal asthma and ~1,000,000 cases of fungal keratitis occur annually.
- 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.
- Conditions
- Invasive Fungal Infections
- Being tested
- Invasive Fungal disease surveillance
- Keywords
- Invasive Fungal Pathogen, Hospitalized patients, Surveillance
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive Fungal disease surveillanceOther
Management of invasive fungal infection according to pathogen identification and susceptibility report.
| Study group | Role | What they receive |
|---|---|---|
| child | identification and management of invasive fungal pathogen Receives: Other: Invasive Fungal disease surveillance | |
| adult | identification and management of invasive fungal pathogen Receives: Other: Invasive Fungal disease surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of laboratory-identified invasive fungal pathogens among hospitalized patients.
The primary goal will be to ensure a sustainable surveillance platform in low-income settings such as Bangladesh. The Investigators will utilize four strategies to establish a sustainable fungal surveillance platform/program in Bangladesh which will be as follows:
- Increase capacity to conduct surveillance
- Identify and respond
- Target and train
- Monitor, evaluate and improve
Measured: July 2022 - September 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start20 Jan 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Institute of Epidemiology, Disease Control and Research
- Responsible party
- Sponsor
- Investigators
- Sayeeda Huq, MBBS,MIPH, Principal investigator, International Centre for Diarrheal Diseases Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103331
- Sponsor's protocol ID
- PR-21142
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance for Invasive Fungal Infections in Selected Hospitals in Dhaka City, Bangladesh
- ClinicalTrials.gov ID
- NCT06103331
- Acronym / sponsor ID
- PR-21142
- Conditions
- Invasive Fungal Infections
- Keywords
- Invasive Fungal Pathogen, Hospitalized patients, Surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Institute of Epidemiology, Disease Control and Research
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 icddr,b, 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
- 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 3,000,000 cases of chronic pulmonary aspergillosis, ~223,100 cases of cryptococcal meningitis complicating HIV/AIDS, ~700,000 cases of invasive candidiasis, ~500,000 cases of Pneumocystis jirovecii pneumonia, ~250,000 cases of invasive aspergillosis, ~100,000 cases of disseminated histoplasmosis, over 10,000,000 cases of fungal asthma and ~1,000,000 cases of fungal keratitis occur annually.
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| child | – | Other: Invasive Fungal disease surveillanceidentification and management of invasive fungal pathogen |
| adult | – | Other: Invasive Fungal disease surveillanceidentification and management of invasive fungal pathogen |
Who may qualify
- Ages
- 0 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients meeting the inclusion criteria and having ONE of the following groups of clinical features suggestive of infection of a particular organ system during sample collection: * Clinical features suggestive of infection of the respiratory system: * Fever or chills WITH * Cough or shortness of breath WITH * Abnormal lung findings on chest auscultation or on chest X-ray or CT scans * Clinical features of sepsis: * Hyperthermia or hypothermia (rectal temperature >38.5 Celsius or <35 Celsius respectively) and tachycardia plus either bounding pulses or, altered mental status or, hypoxemia in absence of pneumonia or, abnormal WBC count (>12×109 ⁄ L or, <4 ×109 ⁄ L or, band and neutrophil ratio ≥ 0.1) or, increased serum lactate level (diagnosed by physicians)
Key inclusion criteria (24 listed)
- Admitted/hospitalized patients of any age and gender in tertiary-level acute care hospitals AND
- Having any of the following co-morbid immunosuppressive conditions or risk factors for healthcare-associated fungal infections such as:
- AND
- Patients or caregivers providing consent
- For children aged <5 years, the age criteria and additional inclusion criteria will be as follows:
Key exclusion criteria (2 listed)
- History of taking antifungal drugs within 2 weeks
- Not willing to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive Fungal disease surveillanceManagement of invasive fungal infection according to pathogen identification and susceptibility report. | Other | adult, child |
Primary outcome
The proportion of laboratory-identified invasive fungal pathogens among hospitalized patients.
Time frame: July 2022 - September 2026
The primary goal will be to ensure a sustainable surveillance platform in low-income settings such as Bangladesh. The Investigators will utilize four strategies to establish a sustainable fungal surveillance platform/program in Bangladesh which will be as follows: 1. Increase capacity to conduct surveillance 2. Identify and respond 3. Target and train 4. Monitor, evaluate and improve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Invasive Fungal Infections
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Invasive Mold Infections
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayeeda Huq, MBBS,MIPH principal investigator
International Centre for Diarrheal Diseases Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sayeeda Huq, MBBS, MIPH (+8801678127723, sayeeda@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of laboratory-identified invasive fungal pathogens among hospitalized patients. (time frame: July 2022 - September 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.