Adjunctive Sirolimus and Oseltamivir Versus Oseltamivir Alone for Treatment of Influenza

• Status: Not yet recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Seasonal influenza epidemics are important causes of mortality and morbidity. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza A(H1N1)pdm09 virus infection, A(H5N1) infection, and A(H7N9) infection. We aim to investigate the effects of adjunctive sirolimus in adults hospitalized with influenza A or B infections involving the lower respiratory tract.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Everolimus; Oseltamivir; Sirolimus

Criteria

Inclusion Criteria:

• influenza A and B virus infections confirmed by PCR and/or immunofluorescence assays, hospitalized for the management of severe manifestations of influenza, presenting within 5 days from illness onset, clinical evidence of lower respiratory tract infection (e.g. shortness of breath, tachypnea, oxygen desaturation, crepitations on auscultation, infiltrations or consolidations on chest radiograph) and ability to provide written informed consent.

Exclusion Criteria:

• use of systemic corticosteroids (except for those who need low dose hydrocortisone 50mg qid for refractory septic shock) or other immunosuppressants (e.g. post-chemotherapy, post-transplant, autoimmune diseases) or with known immuno-compromised conditions (e.g. active haematological malignancies, HIV/AIDS), pregnancy/lactation, end-stage renal failure/hepatic failure/cardiac failure and patients who have received macrolide antibiotics prior to enrolment due to their immuno-modulating effects. Patients on drugs that may interact and alter sirolimus level (rifampicin, azole antifungals, phenytoin, diltiazem, verapamil, nicardipine, metoclopramide, phenobarbital, carbamazepine) will be excluded for safety purposes. Use of investigational anti-influenza antivirals and blood products is also excluded.