NCT04297462

Brief Summary

Although the vaccination is the preferred method of influenza prevention, there are some occasions on which a postexposure prophylaxis (PEP) is required. Two neuraminidase inhibitors (NAIs) may be used in chemoprophylaxis in children: oral oseltamivir, and inhaled zanamivir. Both, oseltamivir and zanamivir, are effective in treatment and in prophylaxis of influenza, and the efficacy is calculated to reach 70-90%. Oseltamivir is used more frequently, since zanamivir is licensed in older children (5 years of age and above), and children under the age of 5 years are at higher risk of influenza complications. Oseltamivir use correlated in children with higher risk of vomiting, with no increased risk of other adverse events, including those observed in adult patients (nausea, renal events, and psychiatric effects). The PEP may be indicated by individual patient's characteristics (e.g. patients in high-risk group) or epidemiological reasons, i.e. prevention of institutional outbreaks.The one research that analyzed efficacy of 3-days PEP versus 7 or 10-days and showed overall efficacy of shorter oseltamivir prophylaxis to be high and comparable to that of longer regimens. The study included several pediatric patients and made the investigators perform such an analysis in pediatric population. In this randomized controlled trial, the investigators aimed to compare efficacy, safety, and costs of 3 versus 7-days prophylaxis with oral oseltamivir in children hospitalized. The hypothesis is that 3-days duration of PEP is not less effective than 7-days PEP, and patients might gain from lower number of adverse reactions related to drug administration.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

3.4 years

First QC Date

February 18, 2020

Last Update Submit

September 7, 2020

Conditions

InfluenzaExposurePrevention

Keywords

influenzachemopreventionoseltamivirchildinfant

Outcome Measures

Primary Outcomes (3)

  • Postexposure chemoprophylaxis efficacy

    Percent of patients who did not have influenza in each study arm.

    up to 7 days after PEP has finished

  • Oseltamivir safety

    Presence of the following adverse reactions to drug (in percents): nausea, vomiting, skin hypersensitivity (including rash), sleep disorders, consciousness disorders, convulsions, fever related to drug administration, symptomatic arrhythmias, behavioral changes

    up to 7 days after PEP has finished

  • Postexposure chemoprophylaxis costs

    Cost of drugs used in each arm, costs of treatment of adverse reactions

    up to 7 days after PEP has finished

Secondary Outcomes (4)

  • Need for hospitalization in case of influenza after failed chemoprophylaxis

    Up to 28 days

  • Duration of influenza signs and symptoms after failed chemoprophylaxis

    Up to 28 days

  • Presence of complications in case of influenza after failed chemoprophylaxis

    Up to 28 days

  • Fever in case of influenza after failed chemoprophylaxis

    Up to 28 days

Study Arms (2)

3-days postexposure chemoprophylaxis

EXPERIMENTAL

Oseltamivir given orally, 3mg per each body kg, once a day during three consecutive days after the contact with influenza

Drug: Oseltamivir 3 days

7-days postexposure chemoprophylaxis

ACTIVE COMPARATOR

Oseltamivir given orally, 3mg per each body kg, once a day during seven consecutive days after the contact with influenza

Drug: Oseltamivir 7 days

Interventions

Oseltamivir 3 daysDRUG

Non-inferiority study of 3 versus 7-days duration of PEP

Also known as: 3-days postexposure chemoprophylaxis with oseltamivir
3-days postexposure chemoprophylaxis
Oseltamivir 7 daysDRUG

Active comparator

Also known as: 7-days postexposure chemoprophylaxis with oseltamivir
7-days postexposure chemoprophylaxis

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients hospitalized at the Pediatric Ward
  • age: 0-18 years old
  • confirmed contact with a person diagnosed with influenza
  • patient's, patient's parent/tutor's informed consent

You may not qualify if:

  • lack of an informed consent
  • more than 48 hours after the first contact with influenza
  • severe adverse reaction to the drug- discontinuation of the prophylaxis
  • important to a parent/tutor drug intolerance (e.g. lack of tolerance of a drug's taste)
  • new contact with influenza after chemoprophylaxis has finished

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre of Postgraduate Medical Education

Warsaw, Masovian Voivodeship, 01-813, Poland

RECRUITING

Related Publications (2)

  • Ishiguro N, Oyamada R, Nasuhara Y, Yamada T, Miyamoto T, Imai S, Akizawa K, Fukumoto T, Iwasaki S, Iijima H, Ono K. Three-day regimen of oseltamivir for postexposure prophylaxis of influenza in wards. J Hosp Infect. 2016 Oct;94(2):150-3. doi: 10.1016/j.jhin.2016.05.012. Epub 2016 May 25.

    PMID: 27346624BACKGROUND

  • Wrotek A, Jackowska T. A noninferiority randomized open-label pilot study of 3- versus 7-day influenza postexposure prophylaxis with oseltamivir in hospitalized children. Sci Rep. 2024 Jun 20;14(1):14192. doi: 10.1038/s41598-024-65244-5.

    PMID: 38902383DERIVED

Related Links

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • August E. Wrotek, MD PhD

    The Centre of Postgraduate Medical Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

August E. Wrotek, MD, PhD

CONTACT

(+48)228641167august.wrotek@bielanski.med.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients randomly allocated into 3 or 7-days postexposure chemoprophylaxis group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2020

First Posted

March 5, 2020

Study Start

November 17, 2016

Primary Completion

March 31, 2020

Study Completion

December 31, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

PL(1)