Status:
RECRUITING
Fungal Surveillance in Bangladesh
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Centers for Disease Control and Prevention
Institute of Epidemiology, Disease Control and Research
Conditions:
Invasive Fungal Infections
Eligibility:
All Genders
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-...
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 calcul...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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,
- 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
Exclusion
- History of taking antifungal drugs within 2 weeks
- Not willing to give consent
Key Trial Info
Start Date :
January 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06103331
Start Date
January 20 2022
End Date
September 30 2026
Last Update
November 22 2023
Active Locations (1)
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1
International Centre for Diarrheal Disease Research, Bangladesh (icddr,b)
Dhaka, Bangladesh, 1212