The Role of Lactate in Viral and Bacterial Infection | NCT04777747

Studies
The Role of Lactate in Viral and Bacterial Infection

NCT04777747

Sponsor

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

Status

Completed

Last Update Posted

May 1, 2023Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Viral Infection
Bacterial Infections
Lactate Blood Increase

Interventions

viral infection
viral and bacterial infection

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Mar 31, 2023Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

Feb 26, 2021

First Submission Date that Met QC Criteria

Mar 1, 2021

First Posted Date

Mar 2, 2021Actual

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, director, Children's Hospital of Chongqing Medical UniversityPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Children's Hospital of Chongqing Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

Detailed Description

Lactate is an important molecule in the spread and metastasis of tumor by suppressing the innate immune response. As is known, the immune system is not mature in children and it is reverse related to the age of children. An reasonable hypothesis is that the lactate is a independent risk factor in the children with viral infection progress to bacterial infection. Here, our aim is to test the hypothesis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
viral infection	Other	a child is infected by virus only	viral infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

one of the following conditions appeared:

congenital heart disease or other abnormalities
respiratory failure
hereditary and/or metabolic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chen		Chongqing	Chongqing Municipality	400014	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

two years after the study accomplishment

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

from Jan-1, 2025 to Dec-31, 2025

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014777	Virus Diseases
D001424	Bacterial Infections
D065906	Hyperlactatemia

Ancestor Terms

ID	Term
D007239	Infections
D001423	Bacterial Infections and Mycoses
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided