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Different Regimens in Influenza Postexposure Chemoprophylaxis in Children

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ClinicalTrials.gov Identifier: NCT04297462
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
August Wrotek, Centre of Postgraduate Medical Education

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
Influenza Exposure Prevention Drug: Oseltamivir 3 days Drug: Oseltamivir 7 days Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients 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 : November 17, 2016
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir

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 Name: 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 Name: 7-days postexposure chemoprophylaxis with oseltamivir




Primary Outcome Measures :
  1. Postexposure chemoprophylaxis efficacy [ Time Frame: up to 7 days after PEP has finished ]
    Percent of patients who did not have influenza in each study arm.

  2. Oseltamivir safety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 28 days ]
    Length of period when signs and symptoms are present

  3. Presence of complications in case of influenza after failed chemoprophylaxis [ Time Frame: 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 [ Time Frame: Up to 28 days ]
    Highest fever and duration of fever



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297462


Contacts
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Contact: August E. Wrotek, MD, PhD (+48)228641167 august.wrotek@bielanski.med.pl

Locations
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Poland
The Centre of Postgraduate Medical Education Recruiting
Warsaw, Mazowieckie, Poland, 01-813
Contact: August E. Wrotek, MD PhD    (+48)228641167    august.wrotek@bielanski.med.pl   
Sponsors and Collaborators
Centre of Postgraduate Medical Education
Investigators
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Principal Investigator: August E. Wrotek, MD PhD The Centre of Postgraduate Medical Education

Additional Information:
Publications:
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Responsible Party: August Wrotek, Principal Investigator, Centre of Postgraduate Medical Education
ClinicalTrials.gov Identifier: NCT04297462    
Other Study ID Numbers: 77/PB/2016
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020

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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, Centre of Postgraduate Medical Education:
influenza
chemoprevention
oseltamivir
child
infant
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action