FindTrial
Sign In

A study to confirm algorithm for diagnosing invasive pulmonary aspergillosis in critically ill mechanically ventilated patients

A preliminary study to validate BM-AspICU algorithm for diagnosing invasive pulmonary aspergillosis in critically ill mechanically ventilated patients using post-mortem minimally invasive tissue sampling

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/07/044004
Enrollment
100
Registered
2022-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Nil: Nil

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient intubated and mechanically ventilated for >= 48 hours 2. The patient has one of the following: A or B or C A . Clinical features 1) Fever refractory to > 3 days of antibiotics 2) Pleuritic chest pain 3) Dyspnea 4) Hemoptysis 5) Respiratory insufficiency despite ventilation support OR B. Imaging sign HRCT thorax or Chest radiography suggestive of >= 1 features 1) Air-crescent sign 2) Cavity 3) Dense, well-circumscribed lesion(s) with or without halo sign 4) Diffuse reticular and alveolar opacities 5) Nonspecific infiltrates and consolidation 6) Pleural fluid 7) Wedge-shaped infiltrate 8) Tree-in-bud pattern OR C. Positive Aspergillus culture in the lower respiratory tract 3. Post-mortem histopathological samples from lungs obtained

Exclusion criteria

Exclusion criteria: 1. Patient or attendants not giving consent for participating in the study 2. Patients whose fungal biomarkers and other investigation reports are not available 3. Patients intubated and mechanically ventilated for

Design outcomes

Primary

MeasureTime frame
1. The diagnostic accuracy of BM-AspICU algorithm would be measured by estimating the sensitivity, specificity, predictive values, likelihood ratio, Youdenâ??s index, diagnostic odds ratio, area under the ROC curve (AUC) as compared to biopsy diagnosis.Timepoint: end of study (36 months)—

Secondary

MeasureTime frame
2. BM-AspICU would be compared with Asp-ICU algorithm by comparing their sensitivity, specificity, predictive values, likelihood ratio, Youdenâ??s index, diagnostic odds ratio, area under the ROC curve (AUC) 3. The different causes of death in the final biopsy samples of patients of suspected invasive pulmonary aspergillosis patients would be recorded in proportions. Timepoint: end of study (36 months)—

Countries

India

Contacts

Public ContactAnimesh Ray

All India Institute of Medical Sciences

doctoranimeshray@gmail.com9560093190

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026