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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-18

Study Completion Date

2019-12-29

Brief Summary

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

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Detailed Description

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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

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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clarithromycin-naproxen-oseltamivir

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

clarithromycin-naproxen-oseltamivir

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- age 1 year to 18 years; body temperature higher than 38 °C; presence of one of the following symptoms-cough, sputum production, sore throat, rhinorrhoea, myalgia, headache, or fatigue presenting within 72 hours from symptom onset; laboratory-confirmed influenza infection (including rapid test or PCR-confirmed influenza A or B); and clinical requirement for hospitalisation. Antiviral treatment was initiated within 48 hours after admission.

Exclusion Criteria

\- a history of allergy or contraindication to the study medications; the administration of medications with macrolides (ex: azithromycin, erythromycin), naproxen or neuraminidase inhibitor use within 72 hours; current use of any antibiotic; and the presence of an immunocompromised state due to steroid use, human immunodeficiency virus infection, chronic kidney disease, renal failure, chemotherapy or radiotherapy in half year, or innate immunodeficiency.

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No