Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients
India216 participantsStarted 2019-11-07
Plain-language summary
Early treatment of invasive fungal infections (IFI) may prevent undue mortality in acute on chronic liver failure (ACLF) patients. We aim to study the impact of early empiric treatment (based on clinical suspicion) of IFI as compared to pre-emptive treatment (based on biomarkers and culture positivity) on the outcomes in ACLF patients with suspected IFI in a randomized trial. The ACLF patients with clinically suspected IFI would be randomly allocated to empiric treatment or pre-emptive treatment group and followed up clinically to assess the impact on survival, clinical outcomes and cost-effectiveness and safety of such an approach. The protocol is designed to cut- down unnecessary usage and to curtail the duration of antifungals use in ICUs based on biomarkers/culture-driven stoppage rules. The results will fuel further studies on formal cost-effective analysis and antimicrobial stewardship protocols in ACLF patients.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ICU stay \>48 hours or admission in a tertiary care hospital prior to the current admission
✓. Two or more risk factors for IFI from amongst the following:-
✓. Mechanically ventilated at least ≥ 48 hours
✓. Treatment with broad-spectrum antibacterial agents for more than 3 days
✓. Arterial or central vein catheter ≥ 2days
✓. Diabetes Mellitus
✓. Total parenteral nutrition ≥ 48 hours
✓. Acute renal failure requiring any form of renal replacement therapy ≥48hours
Exclusion criteria
✕. Neutrophil count of less than 500/mm3
✕. Current or recent antifungal treatment in the past 1 months
✕
What they're measuring
1
Overall Survival
Timeframe: 28 day
Trial details
NCT IDNCT04157465
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh