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Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

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ClinicalTrials.gov Identifier: NCT01930955
Recruitment Status : Recruiting
First Posted : August 29, 2013
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Condition or disease Intervention/treatment Phase
Acute Upper Respiratory Tract Infection Drug: Amoxicillin Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection:a Randomized-control Trial
Actual Study Start Date : August 2011
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. fever [ Time Frame: 3 days ]
    Fever stopped or mitigated in 90% participants.


Secondary Outcome Measures :
  1. vomiting [ Time Frame: 2 days ]
    Vomiting stopped or mitigated in 90% participants.


Other Outcome Measures:
  1. white cell count [ Time Frame: 3 days ]
    White cell count decreased in 90% participants.



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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 0ther symptoms of digestive system
  • Headache

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930955


Contacts
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Contact: Long Chen, MD 8613883559467 neuroclong@126.com

Locations
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China, Chongqing
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Long Chen, MD    8613883559467    neuroclong@126.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
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Principal Investigator: Long Chen, MD Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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Responsible Party: Chen Long,MD, Prof;MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT01930955     History of Changes
Other Study ID Numbers: AURI
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Keywords provided by Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
Non-antibiotic prescribing
acute upper respiratory tract infection
white cell count
vomiting
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents