Fungal Surveillance in Bangladesh

NCT06103331 | Recruiting DMC

• 1 other identifier: PR-21142
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Invasive Fungal Infections

Keywords

Invasive Fungal Pathogen; Hospitalized patients; Surveillance

Outcome Measures

Primary Outcomes (1)

• 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: 1. Increase capacity to conduct surveillance 2. Identify and respond 3. Target and train 4. Monitor, evaluate and improve

  July 2022 - September 2026

Study Arms (2)

child

identification and management of invasive fungal pathogen

Other: Invasive Fungal disease surveillance

adult

identification and management of invasive fungal pathogen

Other: Invasive Fungal disease surveillance

Interventions

Invasive Fungal disease surveillance OTHER

Management of invasive fungal infection according to pathogen identification and susceptibility report.

adult; child

Eligibility Criteria

• Age: 0 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• 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
• to 59-month-old children of either sex admitted in hospital with any illness.

You may not qualify if:

• History of taking antifungal drugs within 2 weeks
• Not willing to give consent

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Centers for Disease Control and Prevention: collaborator
• Institute of Epidemiology, Disease Control and Research: collaborator

Study Sites (1)

International Centre for Diarrheal Disease Research, Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

RECRUITING

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Sayeeda Huq, MBBS,MIPH

  International Centre for Diarrheal Diseases Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sayeeda Huq, MBBS, MIPH

CONTACT

+8801678127723; sayeeda@icddrb.org

Tanzir A Shuvo, MBBS,MPH,PhD

CONTACT

+8801816318802; tanzir@icddrb.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 26, 2023
• Study Start: January 20, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 22, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)