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

Study Overview

• Status: Completed
• Conditions: Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients
• Intervention / Treatment: Drug: clarithromycin-naproxen-oseltamivir

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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 10449
    • Mackay Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study was conducted at Mackay Children's Hospital, Taiwan, between December 2017 and December 2019.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
clarithromycin-naproxen-oseltamivir; Efficacy of clarithromycin-naproxen-oseltamivir combination therapy vs. oseltamivir alone for hospitalised paediatric influenza patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Investigators: Principal Investigator: Chien-Wei Lee, Dr., Mackay Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): December 29, 2019
• Study Completion (Actual): December 29, 2019

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Gout Suppressants; Clarithromycin; Naproxen; Oseltamivir
• Other Study ID Numbers: MackayMH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

The data used to support the findings of this study have not been made available due to legal restrictions imposed by the government of Taiwan in relation to the "Personal Information Protection Act", personal data cannot be made publicly available. However, the investigators could provide disconnected data as follows:

https://drive.google.com/open?id=1zcCZKNBO7kfJFt8AcuZd1Yi2PniAAlwe

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No