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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315194
• Other study ID #: MackayMH
• Status: Completed
• Start date: December 18, 2017
• Est. completion date: December 29, 2019

Study information

• Verified date: March 2020
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 29, 2019
• Est. primary completion date: December 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Mackay Children's Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of symptoms and signs	severity of symptoms and signs presenting on the first, third, and fifth days of admission, including cough, sputum, rhinorrhoea, sore throat, chills, wheezing/stridor, headache, dizziness, shortness of breath, chest pain, vomiting, diarrhoea, muscle pain, and abdominal pain. The duration of fever and length of hospital stay after treatment were also documented.	1 month