Using N-acetylcysteine with Oseltamivir for Severe Influenza in Hospitalized Adults
A Randomized, Double Blind, Placebo Controlled Trial of Intravenous N-acetylcysteine and Oseltamivir Versus Intravenous 5% Dextrose and Oseltamivir in Adults Hospitalized With Influenza Complicated by Lower Respiratory Tract Infection.
This study is testing if adding N-acetylcysteine to the usual flu treatment can help hospitalized adults with severe influenza and pneumonia feel better faster.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03900988 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intravenous N-acetylcysteine (NAC) combined with oseltamivir in adults hospitalized with severe influenza and pneumonia. The study aims to evaluate whether NAC, known for its antioxidant properties, can improve clinical outcomes by reducing inflammation in patients suffering from lower respiratory tract infections. Participants will be randomly assigned to receive either the combination treatment or oseltamivir alone, with outcomes assessed based on respiratory status and overall health improvements. The trial is designed to provide insights into the potential benefits of adjunctive NAC therapy in managing severe influenza cases.
Who should consider this trial
Good fit: Ideal candidates are adults hospitalized with confirmed influenza A or B infections and evidence of lower respiratory tract involvement.
Not a fit: Patients with known immunocompromised conditions, severe organ failures, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce morbidity and mortality associated with severe influenza infections.
How similar studies have performed: Previous case reports have suggested that high-dose NAC may improve clinical outcomes in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * influenza A and B virus infections confirmed by polymerase chain reaction (PCR) and/or immunofluorescence assays, * hospitalized for the management of severe manifestations of influenza, * initiation of oseltamivir, * clinical evidence of lower respiratory tract infection (e.g. shortness of breath, tachypnea, oxygen desaturation \<93% on room air, crepitations on auscultation, infiltrations or consolidations on chest radiograph) * written informed consent (by the subjects, or from their next of kin if the subjects are unable to provide written consent at the time of enrollment) Exclusion Criteria: * use of immunosuppressants (e.g. post-chemotherapy, post-transplant, autoimmune diseases) other than systemic corticosteroids * known immuno-compromised conditions (e.g. active haematological malignancies, HIV/AIDS patients who are on antiretroviral therapy and CD4 cell count \< 200), * pregnancy * lactation, * end-stage renal failure * hepatic failure * cardiac failure * patients on anticoagulation (except prophylactic dose of low molecular weight heparin), * patients with scheduled major surgery within 2 weeks (NAC may affect blood clotting), * patients who have received macrolide antibiotics and NSAID for 1 week prior to enrolment due to their immuno-modulating effects. * Use of investigational anti-influenza antivirals and blood products
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: David SC Hui, MD — Chinese University of Hong Kong
- Study coordinator: Ken Ka Pang Chan, MBChB
- Email: chankapang@cuhk.edu.hk
- Phone: 852 3505 3532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.