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NCT04157465
Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients
NA trial testing Treatment strategy trial in Antifungal Agents in 216 participants. Completed in 31 December 2024.
31 December 2024
Quick facts
| Lead sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 216 |
| Start date | 7 November 2019 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across India |
Drugs / interventions tested
- Treatment strategy trial
Conditions studied
- Antifungal Agents — all drugs for Antifungal Agents →
- Invasive Fungal Infections — all drugs for Invasive Fungal Infections →
- Mycoses — all drugs for Mycoses →
- Acute-On-Chronic Liver Failure — all drugs for Acute-On-Chronic Liver Failure →
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Who can join
Adults 18 to 75, any sex, with Antifungal Agents or Invasive Fungal Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Empirical Antifungal Therapy Improves Survival in Patients With Acute-on-Chronic Liver Failure With Suspected Invasive Fungal Infections: A Pragmatic Randomized Trial.
Verma N, Valsan A, Garg P, Sarabu S, et al · · 2025 · PMID 41268913 · DOI 10.14309/ajg.0000000000003832
Verify or expand the search:
- PubMed search for NCT04157465
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other Post Graduate Institute of Medical Education and Research, Chandigarh trials
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- NCT07280390 — Microplastics, Cirrhosis and Portal Hypertension · not yet recruiting
- NCT07182877 — Comparison of Dwell Time of Open Versus Closed Type Peripheral Intravenous Cannula · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04157465 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Post Graduate Institute of Medical Education and Research, Chandigarh
- Last refreshed: 8 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04157465.
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