Clinical trial NCT04297462: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza
Exposure
Prevention
Keywords: influenza
chemoprevention
oseltamivir
child
infant
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomly allocated into 3 or 7-days postexposure chemoprophylaxis group
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Postexposure chemoprophylaxis efficacy
timeFrame: up to 7 days after PEP has finished
measure: Oseltamivir safety
timeFrame: up to 7 days after PEP has finished
measure: Postexposure chemoprophylaxis costs
timeFrame: up to 7 days after PEP has finished
Secondary outcomes:
measure: Need for hospitalization in case of influenza after failed chemoprophylaxis
timeFrame: Up to 28 days
measure: Duration of influenza signs and symptoms after failed chemoprophylaxis
timeFrame: Up to 28 days
measure: Presence of complications in case of influenza after failed chemoprophylaxis
timeFrame: Up to 28 days
measure: Fever in case of influenza after failed chemoprophylaxis
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Centre of Postgraduate Medical Education
state: Mazowieckie
Study officials:
affiliation: The Centre of Postgraduate Medical Education
name: August E. Wrotek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.