Non-antibiotic Prescribing for Acute Upper Respiratory Tr... | NCT01930955

Studies
Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

NCT01930955

Sponsor

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

Status

Withdrawn

Last Update Posted

May 1, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Acute Upper Respiratory Tract Infection

Interventions

Amoxicillin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no patients were included

Expanded Access Info

Start Date

Aug 1, 2011Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Aug 20, 2013

First Submission Date that Met QC Criteria

Aug 28, 2013

First Posted Date

Aug 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2023

Last Update Posted Date

May 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Long,MD, Prof;MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amoxicillin	Active Comparator	Amoxicillin were given to the children with acute upper respiratory tract infection characterized by fever and vomiting.	Drug: Amoxicillin
control	No Intervention	Non-antibiotics were given to the children with acute upper respiratory tract infection characterized by fever and vomiting.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amoxicillin	Drug	β-lactam antibiotics	Amoxicillin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute upper respiratory tract infection
Fever
Vomiting
Increased white blood cell

Exclusion Criteria:

0ther symptoms of digestive system
Headache

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Long Chen, MD	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University		Chongqing	Chongqing Municipality	400042	China

Condition Browse Module

MeSH Terms

ID	Term
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000658	Amoxicillin

Ancestor Terms

ID	Term
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769

Browse Leaves

Not provided

Browse Branches

Not provided