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

Phase 4

Completed

• Conditions: Herpangina
• Interventions: Drug: Recombinant Human Interferon α-2b Spray; Drug: Ribavirin

• Registration Number: NCT03266601
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 668

Inclusion Criteria

Subjects should meet all of the following:

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

Exclusion Criteria

Subjects should be excluded if meet any of the following:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant Human Interferon α-2b Spray	Recombinant Human Interferon α-2b Spray	-
Ribavirin	Ribavirin	-

Primary Outcome Measures

Name	Time	Method
The defervesce rate during treatment by 72 hours	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 Outcome Measures

Name	Time	Method
Abnormal blood routine	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".
The effective rate	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.
The ineffective rate	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.
The total effective rate	From starting of treatment to the 96th hour.	Total effective rate = efficiency rate + effective rate.
Appetite improvement	From starting of treatment to the 96th hour.
The condition of herpes and ulcers subside	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
The significant efficiency rate	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.
Total hospital stay	From starting of treatment to the 96th hour.
Myocardial enzymes and electrocardiogram	Before admission and 72th hours after treatment.	Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China