Different Regimens in Influenza Postexposure Chemoprophylaxis in Children

Sponsor
Centre of Postgraduate Medical Education (Other)
Overall Status
Recruiting
CT.gov ID
NCT04297462
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oseltamivir 3 days
  • Drug: Oseltamivir 7 days
N/A

Detailed Description

Only applies to patients hospitalized due to other than influenza reasons. If a proven contact with influenza has taken place (influenza diagnosed by signs/symptoms and positive rapid influenza diagnostic test and/or PCR), a patient may be enrolled.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients randomly allocated into 3 or 7-days postexposure chemoprophylaxis groupPatients randomly allocated into 3 or 7-days postexposure chemoprophylaxis group
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy of Different Regimens in Influenza Postexposure Chemoprophylaxis With Oral Neuraminidase Inhibitor in Children
Actual Study Start Date :
Nov 17, 2016
Actual Primary Completion Date :
Mar 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3-days postexposure chemoprophylaxis

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

Drug: Oseltamivir 3 days
Non-inferiority study of 3 versus 7-days duration of PEP
Other Names:
  • 3-days postexposure chemoprophylaxis with oseltamivir
  • Active Comparator: 7-days postexposure chemoprophylaxis

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

    Drug: Oseltamivir 7 days
    Active comparator
    Other Names:
  • 7-days postexposure chemoprophylaxis with oseltamivir
  • Outcome Measures

    Primary Outcome Measures

    1. Postexposure chemoprophylaxis efficacy [up to 7 days after PEP has finished]

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

    2. Oseltamivir safety [up to 7 days after PEP has finished]

      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

    3. Postexposure chemoprophylaxis costs [up to 7 days after PEP has finished]

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

    Secondary Outcome Measures

    1. Need for hospitalization in case of influenza after failed chemoprophylaxis [Up to 28 days]

      A need for hospitalization if influenza is present within 7 days after PEP completion

    2. Duration of influenza signs and symptoms after failed chemoprophylaxis [Up to 28 days]

      Length of period when signs and symptoms are present

    3. Presence of complications in case of influenza after failed chemoprophylaxis [Up to 28 days]

      Presence of influenza complications: pneumonia, bronchitis, otitis media, need for antibiotic treatment, neurological sequelae, ICU transfer, death

    4. Fever in case of influenza after failed chemoprophylaxis [Up to 28 days]

      Highest fever and duration of fever

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Centre of Postgraduate Medical Education Warsaw Mazowieckie Poland 01-813

    Sponsors and Collaborators

    • Centre of Postgraduate Medical Education

    Investigators

    • Principal Investigator: August E. Wrotek, MD PhD, The Centre of Postgraduate Medical Education

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    August Wrotek, Principal Investigator, Centre of Postgraduate Medical Education
    ClinicalTrials.gov Identifier:
    NCT04297462
    Other Study ID Numbers:
    • 77/PB/2016
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Sep 9, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by August Wrotek, Principal Investigator, Centre of Postgraduate Medical Education
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2020