Different Regimens in Influenza Postexposure Chemoprophylaxis in Children

Influenza Clinical Trial

Official title:

Efficacy of Different Regimens in Influenza Postexposure Chemoprophylaxis With Oral Neuraminidase Inhibitor in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297462
• Other study ID #: 77/PB/2016
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Centre of Postgraduate Medical Education
• Contact: August E. Wrotek, MD, PhD
• Phone: (+48)228641167
• Email: august.wrotek[@]bielanski.med.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Exposure
• Influenza
• Influenza, Human
• Prevention

Intervention

Drug:
• Oseltamivir 3 days
Non-inferiority study of 3 versus 7-days duration of PEP
• Oseltamivir 7 days
Active comparator

Locations

Country	Name	City	State
Poland	The Centre of Postgraduate Medical Education	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postexposure chemoprophylaxis efficacy	Percent of patients who did not have influenza in each study arm.	up to 7 days after PEP has finished
Primary	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
Primary	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	Need for hospitalization in case of influenza after failed chemoprophylaxis	A need for hospitalization if influenza is present within 7 days after PEP completion	Up to 28 days
Secondary	Duration of influenza signs and symptoms after failed chemoprophylaxis	Length of period when signs and symptoms are present	Up to 28 days
Secondary	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	Up to 28 days
Secondary	Fever in case of influenza after failed chemoprophylaxis	Highest fever and duration of fever	Up to 28 days

External Links

•   Three-day regimen of oseltamivir for postexposure prophylaxis of influenza in wards.