NCT04315194

Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

Efficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for hospitalised paediatric influenza patients

Detailed description

This study aimed to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients. This prospective, single-blinded study included patients hospitalised for influenza infection aged 1 year to 18 years, at MacKay Children's Hospital, Taiwan, between December 2017 and December 2019. The primary outcomes were respiratory symptom severity and the signs that presented within hospitalisation. The durations of fever and hospital stay were also documented. The secondary outcome measures were serial changes in the virus titres, as detected by real-time polymerase chain reaction. Totally 54 patients were enrolled (28 in the control group and 26 in the combination group). There were no differences in the patients' baseline characteristics between the groups. The time to defervescence was significantly shorter in the combination group than the oseltamivir group (13.2 hours vs 32.1 hours, p=0.002). The decrease in the virus titre was more pronounced from days 1 to 3 (log Δ13) in the combination group than the oseltamivir group.(log Δ13: 39% vs 19%, p=0.001). In paediatric settings, combination therapy may be used selectively among patients with a history of febrile convulsion or families anxious about the discomforts associated with the fever itself.

Conditions

• Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients

Interventions

Type	Name	Description
DRUG	clarithromycin-naproxen-oseltamivir	to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients.

Timeline

• Start date: 2017-12-18
• Primary completion: 2019-12-29
• Completion: 2019-12-29
• First posted: 2020-03-19
• Last updated: 2020-03-19

Locations

1 site across 1 country: Taiwan