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An observational cohort study of the efficacy and safety of malbaloxavir and oseltamivir in adult influenza patients in China

An observational cohort study of the efficacy and safety of malbaloxavir and oseltamivir in adult influenza patients in China

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115717
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Interventions

Adult influenza patients treated with marbaloxavir:None
Adult patients with influenza treated with maoseltamivir:None

Sponsors

The eighth affiliated hospital of Sun Yat-Sen university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; Weight >= 60 kg; Gender not limited. 2. Adult patients with influenza who have received treatment with maribavir or oseltamivir.

Exclusion criteria

Exclusion criteria: 1. Significant exacerbation of underlying diseases; 2. Patients with severe influenza; 3. Severe influenza (according to the 2020 WHO Influenza Diagnosis and Treatment Protocol) includes any one of the following: (1) Persistent high fever for > 3 days, accompanied by severe cough, sputum purulence, bloody sputum, or chest pain; (2) Rapid respiratory rate, dyspnea, cyanosis of lips; (3) Mental changes such as slow reaction, lethargy, restlessness, convulsion or convulsion; (4) Severe vomiting, diarrhea, and dehydration; (5) Chest imaging showed large areas of lung exudation and other pneumonia changes; (6) Other clinical conditions requiring hospitalization; 4. Co-infection requiring systemic antimicrobial and/or antiviral therapy (non-influenza) detected by baseline screening; 5. Check the use of anti-influenza drugs (including: maribavir, oseltamivir, zanamivir, peramivir, abidol, favelavir, amantadine and rimantadine) within 30 days before dose; 6. Patients who used traditional Chinese medicine (TCM) with antiviral effect of influenza according to the instructions and with high-level RCT evidence after the onset of symptoms (other TCM used before the visit were recorded as medication history); 7. Patients with severe liver impairment (Child-Pugh class C), renal impairment (creatinine clearance <=50 mL/min); 8. Immunocompromised patients after organ or bone marrow transplantation; 9. Suspected or confirmed COVID-19; 10. Have participated in a drug clinical trial in the past year; 11. Allergy to maribavir/excipients or other contraindications to maribavir; 12. Were considered by the investigator to have other conditions for which maribavir therapy was not appropriate (e.g., patient could not swallow tablets, pregnancy).

Design outcomes

Primary

MeasureTime frame
Demographic characteristics (including gender, age, height, weight, etc.);Clinical data;Efficacy and adverse reactions;Quantitative detection of influenza virus RNA;

Secondary

MeasureTime frame
Blood routine, biochemistry, liver function and renal function;Inflammatory factors;Chest imaging;

Countries

China

Contacts

Public ContactWu Haidong

The eighth affiliated hospital of Sun Yat-Sen university

wywhd@163.com+86 133 0220 8135

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026