Different Regimens in Influenza Postexposure Chemoprophylaxis in Children
Primary Purpose
Influenza, Exposure, Prevention
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Oseltamivir 3 days
Oseltamivir 7 days
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, chemoprevention, oseltamivir, child, infant
Eligibility 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
Sites / Locations
- The Centre of Postgraduate Medical EducationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3-days postexposure chemoprophylaxis
7-days postexposure chemoprophylaxis
Arm Description
Oseltamivir given orally, 3mg per each body kg, once a day during three consecutive days after the contact with influenza
Oseltamivir given orally, 3mg per each body kg, once a day during seven consecutive days after the contact with influenza
Outcomes
Primary Outcome Measures
Postexposure chemoprophylaxis efficacy
Percent of patients who did not have influenza in each study arm.
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
Postexposure chemoprophylaxis costs
Cost of drugs used in each arm, costs of treatment of adverse reactions
Secondary Outcome Measures
Need for hospitalization in case of influenza after failed chemoprophylaxis
A need for hospitalization if influenza is present within 7 days after PEP completion
Duration of influenza signs and symptoms after failed chemoprophylaxis
Length of period when signs and symptoms are present
Presence of complications in case of influenza after failed chemoprophylaxis
Presence of influenza complications: pneumonia, bronchitis, otitis media, need for antibiotic treatment, neurological sequelae, ICU transfer, death
Fever in case of influenza after failed chemoprophylaxis
Highest fever and duration of fever
Full Information
NCT ID
NCT04297462
First Posted
February 18, 2020
Last Updated
September 7, 2020
Sponsor
Centre of Postgraduate Medical Education
1. Study Identification
Unique Protocol Identification Number
NCT04297462
Brief Title
Different Regimens in Influenza Postexposure Chemoprophylaxis in Children
Official Title
Efficacy of Different Regimens in Influenza Postexposure Chemoprophylaxis With Oral Neuraminidase Inhibitor in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 17, 2016 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Exposure, Prevention
Keywords
influenza, chemoprevention, oseltamivir, child, infant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomly allocated into 3 or 7-days postexposure chemoprophylaxis group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3-days postexposure chemoprophylaxis
Arm Type
Experimental
Arm Description
Oseltamivir given orally, 3mg per each body kg, once a day during three consecutive days after the contact with influenza
Arm Title
7-days postexposure chemoprophylaxis
Arm Type
Active Comparator
Arm Description
Oseltamivir given orally, 3mg per each body kg, once a day during seven consecutive days after the contact with influenza
Intervention Type
Drug
Intervention Name(s)
Oseltamivir 3 days
Other Intervention Name(s)
3-days postexposure chemoprophylaxis with oseltamivir
Intervention Description
Non-inferiority study of 3 versus 7-days duration of PEP
Intervention Type
Drug
Intervention Name(s)
Oseltamivir 7 days
Other Intervention Name(s)
7-days postexposure chemoprophylaxis with oseltamivir
Intervention Description
Active comparator
Primary Outcome Measure Information:
Title
Postexposure chemoprophylaxis efficacy
Description
Percent of patients who did not have influenza in each study arm.
Time Frame
up to 7 days after PEP has finished
Title
Oseltamivir safety
Description
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
Time Frame
up to 7 days after PEP has finished
Title
Postexposure chemoprophylaxis costs
Description
Cost of drugs used in each arm, costs of treatment of adverse reactions
Time Frame
up to 7 days after PEP has finished
Secondary Outcome Measure Information:
Title
Need for hospitalization in case of influenza after failed chemoprophylaxis
Description
A need for hospitalization if influenza is present within 7 days after PEP completion
Time Frame
Up to 28 days
Title
Duration of influenza signs and symptoms after failed chemoprophylaxis
Description
Length of period when signs and symptoms are present
Time Frame
Up to 28 days
Title
Presence of complications in case of influenza after failed chemoprophylaxis
Description
Presence of influenza complications: pneumonia, bronchitis, otitis media, need for antibiotic treatment, neurological sequelae, ICU transfer, death
Time Frame
Up to 28 days
Title
Fever in case of influenza after failed chemoprophylaxis
Description
Highest fever and duration of fever
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
August E. Wrotek, MD, PhD
Phone
(+48)228641167
Email
august.wrotek@bielanski.med.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
August E. Wrotek, MD PhD
Organizational Affiliation
The Centre of Postgraduate Medical Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Centre of Postgraduate Medical Education
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-813
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
August E. Wrotek, MD PhD
Phone
(+48)228641167
Email
august.wrotek@bielanski.med.pl
12. IPD Sharing Statement
Citations:
PubMed Identifier
27346624
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=ishiguro+postexposure
Description
Three-day regimen of oseltamivir for postexposure prophylaxis of influenza in wards.
Learn more about this trial
Different Regimens in Influenza Postexposure Chemoprophylaxis in Children
We'll reach out to this number within 24 hrs