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NCT Number: NCT03266601

Effect of Recombinant Human Interferon α-2b Spray on Herpangina

This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina.

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Key information

Conditions

Herpangina Coxsackievirus Infections Echovirus Infections Enterovirus Infections Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Fudan University

Shanghai, 201102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects should meet all of the following:

  • meet the diagnostic criteria for pediatric herpangina;
  • ages 1-7 years, no limitation for gender;
  • within 72 hours of onset;
  • the main organs (heart, liver, kidney and lung) function normally;
  • follow up according to requirements and be hospitalized for observation;
  • the guardian is fully informed and signed informed consent.

Exclusion criteria

Subjects should be excluded if meet any of the following:

  • have allergy history of interferon;
  • heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient;
  • children with epilepsy or other neurological disorders;
  • other pathogens exist at the same time;
  • the researchers believe that it is not appropriate to participate in this study.

Treatment and study plan

Recombinant Human Interferon α-2b Spray

Drug

Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).

Ribavirin

Drug

Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).

Primary outcomes

  1. The defervesce rate during treatment by 72 hours

    Time frame: Measure the body temperature every 4 hours from starting of treatment to the 96th hour.

    Body temperature returned to normal,and remain at least 24 hours.

Secondary outcomes

  1. Abnormal blood routine

    Time frame: Before admission and 72th hours after treatment.

    White blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, hemoglobin, the five indicators if one is abnormal, abnormal blood routine is defined as "1", if five indicators all are normal, abnormal blood routine is defined as "0".

  2. The significant efficiency rate

    Time frame: From starting of treatment to the 48th hour.

    Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved.

  3. The effective rate

    Time frame: From starting of treatment to the 72th hour.

    Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved.

  4. The ineffective rate

    Time frame: From starting of treatment to the 96th hour.

    After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty.

  5. The total effective rate

    Time frame: From starting of treatment to the 96th hour.

    Total effective rate = efficiency rate + effective rate.

  6. Total hospital stay

    Time frame: From starting of treatment to the 96th hour.

  7. Appetite improvement

    Time frame: From starting of treatment to the 96th hour.

  8. Myocardial enzymes and electrocardiogram

    Time frame: Before admission and 72th hours after treatment.

    Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal.

  9. The condition of herpes and ulcers subside

    Time frame: Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.

    Clinical examination to check herpes subsided, ulcer wounds smaller, with or

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Anhui Provincial Children's Hospital
  • Changhai Hospital
  • Children's Hospital of Chongqing Medical University
  • Children's Hospital of Kaifeng City
  • Hunan Children's Hospital
  • Qilu Children's Hospital of Shandong University
  • Shenzhen Children's Hospital
  • Tianjin Sinobioway Biomedicine Co.Ltd.
  • Yuying Children's Hospital of Wenzhou Medical University
  • Zunyi Medical College

Registry information

Official study title

Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2017
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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