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临床试验/NCT04297462
NCT04297462Unknown不适用

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

Centre of Postgraduate Medical Education1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Postexposure chemoprophylaxis efficacy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

3-days postexposure chemoprophylaxis

Experimental

Oseltamivir given orally, 3mg per each body kg, once a day during three consecutive days after the contact with influenza

干预措施: Oseltamivir 3 days (Drug)

7-days postexposure chemoprophylaxis

Active Comparator

Oseltamivir given orally, 3mg per each body kg, once a day during seven consecutive days after the contact with influenza

干预措施: Oseltamivir 7 days (Drug)

结局指标

主要结局

Postexposure chemoprophylaxis efficacy

时间窗: up to 7 days after PEP has finished

Percent of patients who did not have influenza in each study arm.

Oseltamivir safety

时间窗: 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

Postexposure chemoprophylaxis costs

时间窗: up to 7 days after PEP has finished

Cost of drugs used in each arm, costs of treatment of adverse reactions

次要结局

  • Need for hospitalization in case of influenza after failed chemoprophylaxis(Up to 28 days)
  • Duration of influenza signs and symptoms after failed chemoprophylaxis(Up to 28 days)
  • Presence of complications in case of influenza after failed chemoprophylaxis(Up to 28 days)
  • Fever in case of influenza after failed chemoprophylaxis(Up to 28 days)

研究者

发起方
Centre of Postgraduate Medical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

August Wrotek

Principal Investigator

Centre of Postgraduate Medical Education

研究点 (1)

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