Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community

NCT03824847 | Suspended Phase 4

• 1 other identifier: DKMI010.1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a double-blind randomised placebo-controlled study in naturally occurring influenza virus infections in the community setting to compare the impact of a short course of clarithromycin versus placebo, on the clinical course, viral shedding, immunomodulation, and the antimicrobial resistance pattern of respiratory bacterial carriage of the patients.

Conditions

Influenza, Human

Keywords

Macrolides; Immunomodulation

Outcome Measures

Primary Outcomes (2)

• Time from recruitment to cessation of clinical illness

  Defined as the time when all relevant clinical symptoms are resolved.

  10 days

• Time from recruitment to cessation of viral shedding

  Defined as the time when no virus is detected by RT-PCR from both nasal and throat swabs.

  10 days

Secondary Outcomes (6)

• Duration and severity of individual symptoms

  10 days

• Incidence of secondary complications

  28 days

• Health-related quality of life

  28 days

• Geometric mean rise in antibody titre against the infecting type or subtype of influenza virus

  28 days

• Changes in blood immunity (Cytokine/chemokine and pro-inflammatory mediators)

  7 days

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Intervention group: clarithromycin 1 tablet (250mg) twice daily for three days

Drug: Clarithromycin 250 MG

Placebo group

PLACEBO COMPARATOR

Placebo group: (identical-looking) placebo 1 tablet twice daily for three days.

Drug: Placebos

Interventions

Clarithromycin 250 MG DRUG

Clarithromycin 1 tablet (250mg) twice daily for three days

Intervention group

Placebos DRUG

Placebo group: (identical-looking) placebo 1 tablet twice daily for three days

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged between 18-60
• Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature ≥37.8°C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) to university health clinics within 48 hours of illness onset.

You may not qualify if:

• Allergy to clarithromycin or any other macrolides or the ingredients in the tablets, which include microcrystalline cellulose, croscarmelose sodium, magnesium stearate and povidon will be excluded.
• Patients with a history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication, or any underlying immunocompromised condition or receiving immunosuppressive agents will also be excluded.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Public Health, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Dennis KM Ip, MD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

HK (1)