drugset / Trial / NCT03900988

Intravenous N-acetylcysteine and Oseltamivir Versus Oseltamivir in Adults Hospitalized With Influenza and Pneumonia

NCT03900988

Phase 3 Unknown 160 enrolled Chinese University of Hong Kong
RandomizedParallel-groupTriple-blindTreatment

Summary

Seasonal influenza epidemics are important causes of morbidity and mortality. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza. Early therapy with a neuraminidase inhibitor (NAI) is associated with better outcome in patients hospitalized with influenza, but significant mortality occurs despite use of antivirals. N-acetylcysteine (NAC) is a modified form of the amino acid cysteine, with anti-oxidant properties. NAC was shown to inhibit the production of pro-inflammatory molecules in lung epithelial cells infected with influenza viruses. Previous case report showed that high dose NAC, administered as continuous intravenous infusion, was effective and safe in improving the clinical outcomes. We aim to perform a randomized controlled trial to evaluate the therapeutic role of adjunctive NAC in the clinical management of patients with influenza complicated by lower respiratory tract involvement and abnormal respiratory status. Such information when available may reveal the potential of NAC for optimization of management of severe influenza, and provide important insights into future adjunctive therapy research.

Timeline

Start
2023-05-08
Primary completion
2025-10-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator N-acetylcysteine Small molecule 100 mg/kg Intravenous
Comparator Oseltamivir Small molecule 75 mg Oral

Indications