Three-day regimen of oseltamivir for postexposure prophylaxis

JRCT ID: jRCTs011180015

Registered date:14/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Individuals who shared a room with influenza patient (index case)
• Date of first enrollment: 01/12/2016
• Target sample size: 279
• Study type: Interventional
• Intervention(s): Individuals who shared a room with the influenza patient with a positive immuno-chromatographic test were given oseltamivir for three days as post-exposure prophylaxis.

Outcome(s)

• Primary Outcome: Primary outcome of this study is occurrence of influenza infection after a three-day regimen of oseltamivir as postexposure prophylaxis. Individuals who shared a room with the index patient infected with influenza were monitored for influenza-like symptoms for seven days after postexposure prophylaxis.
• Secondary Outcome: Secondary outcomes of this study are the association between occurrence of influenza infection after a three-day regimen of oseltamivir as postexposure prophylaxis and the following factors: age, sex, vaccination and underlining diseases of individuals who shared a room with the index patient infected with influenza.

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients older than one year of age.
2. Individuals who shared a room with influenza patient (index case) with a positive immuno-chromatographic test were immediately separated from the index case by transferring to isolation room.
3. Oseltamivir for post-exposure prophylaxis was started within 48 hours after the onset of fever in the index case.
4. Written informed consent was obtained from each patient before enrolment.

Exclude criteria

1. Patients with renal insufficiency (creatinine clearance less than 30 mL/min).
2. Patients older than 10 years and younger than 20 years.
3. Any other patients who are regarded as unsuitable for this study by the investigator.

Related Information

• Primary Sponsor: Ishiguro Nobuhisa
• Secondary ID(s): UMIN000024458