Efficacy of combination therapy with oseltamivir phosphate and azithromycin for influenza: a multicenter, open-label,
Hiroshi Kakeya1, Masafumi Seki2, Koichi Izumikawa3
1Department of Infection Control Science, Graduate School of Medicine, Osaka City University, Osaka, Japan; Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Background:
Macrolides have antibiotic and immunomodulatory activities, which may have a favorable effect on the clinical outcome of patients with infections, including influenza. This study aimed to evaluate the effects of combination therapy with an anti-influenza agent, oseltamivir, and a single-dose formulation of azithromycin (AZM), which has been used for influenza-related secondary pneumonia, on influenza patients. The primary endpoint was a change in the expression levels of inflammatory cytokines. Secondary endpoints were the time required for resolution of influenza-related symptoms, incidence of complications, and adverse reactions.
Methods:
Patients with seasonal influenza were enrolled in this multicenter, open-label, randomized study. Patients were stratified according to the presence of a high risk factor and were randomized to receive combination therapy with oseltamivir plus an extended-release formulation of AZM (combo-group) or oseltamivir monotherapy (mono-group).
Results:
We enrolled 107 patients and randomized them into the mono-group (56 patients) or the combo-group (51 patients). All patients were diagnosed with influenza A infection, and none of the patients had comorbid pneumonia. Statistically significant differences were not observed in the expression levels of inflammatory cytokines and chemokines between the 2 groups. The maximum temperature in the combo-group was lower than that in the mono-group on day 3 through day 5 (p = 0.048), particularly on day 4 (p = 0.037).
Conclusion:
To our knowledge, this is the first prospective, randomized, clinical trial of oseltamivir and AZM combination therapy for influenza. Although the difference in inflammatory cytokine expression level was not statistically significant, combination therapy showed an early resolution of some symptoms.
Name Of Registry:
University hospital Medical Information Network (UMIN).
Trial Registration No:
UMIN000005371.
Insights
This study found that combining oseltamivir with azithromycin (AZM) for influenza did not significantly alter inflammatory cytokine levels. However, combination therapy did show a trend towards earlier symptom resolution in influenza patients.
Area of Science:
- Infectious Diseases
- Pharmacology
- Immunology
Background:
- Macrolides, including azithromycin (AZM), possess antibiotic and immunomodulatory properties.
- Influenza and its associated secondary pneumonia are significant public health concerns.
- Assessing novel therapeutic strategies for influenza is crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of combination therapy with oseltamivir and azithromycin (AZM) in influenza patients.
- To investigate the impact of this combination on inflammatory cytokine expression.
- To assess secondary endpoints including symptom resolution, complication rates, and adverse events.
Main Methods:
- A multicenter, open-label, randomized study involving 107 seasonal influenza patients.
- Patients were stratified by risk factors and randomized to receive either oseltamivir monotherapy or combination therapy (oseltamivir + AZM).
- Primary endpoint: change in inflammatory cytokine expression; Secondary endpoints: symptom duration, complications, and adverse reactions.
Main Results:
- No statistically significant differences in inflammatory cytokine and chemokine expression were observed between the groups.
- The combination therapy group exhibited lower maximum temperatures from day 3 to day 5 post-treatment compared to the monotherapy group (p=0.048).
- Specifically, a significant difference in maximum temperature was noted on day 4 (p=0.037).
Conclusions:
- This is the first prospective randomized clinical trial investigating oseltamivir and AZM combination therapy for influenza.
- While not reaching statistical significance for cytokine modulation, the combination therapy demonstrated potential for earlier resolution of certain influenza symptoms.
- Further research may be warranted to explore the clinical utility of this combination for specific patient populations or symptom profiles.
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