Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

April 28, 2023 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection：a Randomized-control Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

After inclusion of eligible children patients,one group was prescribed amoxicillin,and another not.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 0ther symptoms of digestive system
  • Headache

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amoxicillin
Amoxicillin were given to the children with acute upper respiratory tract infection characterized by fever and vomiting.
Drug: Amoxicillin
β-lactam antibiotics
No Intervention: control
Non-antibiotics were given to the children with acute upper respiratory tract infection characterized by fever and vomiting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fever
Time Frame: 3 days
Fever stopped or mitigated in 90% participants.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vomiting
Time Frame: 2 days
Vomiting stopped or mitigated in 90% participants.
2 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
white cell count
Time Frame: 3 days
White cell count decreased in 90% participants.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Investigators

  • Principal Investigator: Long Chen, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AURI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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