NCT04777747

Brief Summary

Acute upper respiratory tract infection(AURI) is common in children, and viral infection is the main cause. However, several children with viral infection are easy to suffer from secondary bacterial infection, and the mechanism is unclear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 1, 2023

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

February 26, 2021

Last Update Submit

April 28, 2023

Conditions

Viral InfectionBacterial InfectionsLactate Blood Increase

Outcome Measures

Primary Outcomes (2)

  • level of lactate

    level of lactate in both viral and viral and bacterial infection groups

    three days after admission

  • the level of lactate dehydrogenase(LDH)

    level of LDH in both viral and viral and bacterial infection groups

    three days after admission

Study Arms (2)

viral infection

a child is infected by virus only

Other: viral infection

viral and bacterial infection

a child is infected by virus and progress to bacterial infection

Other: viral and bacterial infection

Interventions

viral infectionOTHER

a child is infected by virus only

viral infection
viral and bacterial infectionOTHER

a child is infected by virus and progress to bacterial infection

viral and bacterial infection

Eligibility Criteria

Age1 Minute - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The age of a child ranged from 0 to 18 is included in the present study, especially the first viral infection.

You may qualify if:

  • child's age is from 0 to 18 years
  • a child is at least diagnosed with viral infection

You may not qualify if:

  • one of the following conditions appeared:
  • congenital heart disease or other abnormalities
  • respiratory failure
  • hereditary and/or metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chen

Chongqing, Chongqing Municipality, 400014, China

Location

MeSH Terms

Conditions

Virus DiseasesBacterial InfectionsHyperlactatemia

Condition Hierarchy (Ancestors)

InfectionsBacterial Infections and MycosesMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 2, 2021

Study Start

January 1, 2021

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

May 1, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

two years after the study accomplishment

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
from Jan-1, 2025 to Dec-31, 2025

Locations

CN(1)