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Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

Primary Purpose

Acute Upper Respiratory Tract Infection

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Amoxicillin
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Respiratory Tract Infection focused on measuring Non-antibiotic prescribing, acute upper respiratory tract infection, white cell count, vomiting

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute upper respiratory tract infection
  • Fever
  • Vomiting
  • Increased white blood cell

Exclusion Criteria:

  • 0ther symptoms of digestive system
  • Headache

Sites / Locations

  • Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Amoxicillin

control

Arm Description

Amoxicillin were given to the children with acute upper respiratory tract infection characterized by fever and vomiting.

Non-antibiotics were given to the children with acute upper respiratory tract infection characterized by fever and vomiting.

Outcomes

Primary Outcome Measures

fever
Fever stopped or mitigated in 90% participants.

Secondary Outcome Measures

vomiting
Vomiting stopped or mitigated in 90% participants.

Full Information

First Posted
August 20, 2013
Last Updated
April 28, 2023
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01930955
Brief Title
Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection
Official Title
Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection：a Randomized-control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no patients were included
Study Start Date
August 1, 2011 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Some acute upper respiratory tract infection(AURI) in children is characterized by fever and vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC) usually increased in this children patients,hence antibiotics are often prescribed properly assumed. In the present study, it was hypothesized that it was not necessary to prescribe amoxicillin for the children.
Detailed Description
After inclusion of eligible children patients,one group was prescribed amoxicillin,and another not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Tract Infection
Keywords
Non-antibiotic prescribing, acute upper respiratory tract infection, white cell count, vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin
Arm Type
Active Comparator
Arm Description
Amoxicillin were given to the children with acute upper respiratory tract infection characterized by fever and vomiting.
Arm Title
control
Arm Type
No Intervention
Arm Description
Non-antibiotics were given to the children with acute upper respiratory tract infection characterized by fever and vomiting.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
β-lactam antibiotics
Primary Outcome Measure Information:
Title
fever
Description
Fever stopped or mitigated in 90% participants.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
vomiting
Description
Vomiting stopped or mitigated in 90% participants.
Time Frame
2 days
Other Pre-specified Outcome Measures:
Title
white cell count
Description
White cell count decreased in 90% participants.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute upper respiratory tract infection Fever Vomiting Increased white blood cell Exclusion Criteria: 0ther symptoms of digestive system Headache
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Chen, MD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Learn more about this trial

Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

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