NCT01930955

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 1, 2023

Status Verified

February 1, 2021

Enrollment Period

11.4 years

First QC Date

August 20, 2013

Last Update Submit

April 28, 2023

Conditions

Acute Upper Respiratory Tract Infection

Keywords

Non-antibiotic prescribingacute upper respiratory tract infectionwhite cell countvomiting

Outcome Measures

Primary Outcomes (1)

  • fever

    Fever stopped or mitigated in 90% participants.

    3 days

Secondary Outcomes (1)

  • vomiting

    2 days

Other Outcomes (1)

  • white cell count

    3 days

Study Arms (2)

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

AmoxicillinDRUG

β-lactam antibiotics

Amoxicillin

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • ther symptoms of digestive system
  • Headache

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Vomiting

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Long Chen, MD

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof;MD

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 29, 2013

Study Start

August 1, 2011

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

May 1, 2023

Record last verified: 2021-02

Locations

CN(1)