- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777747
The Role of Lactate in Viral and Bacterial Infection
April 28, 2023 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
The Role of Lactate From Viral to Bacterial Infection
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400014
- Chen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The age of a child ranged from 0 to 18 is included in the present study, especially the first viral infection.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
viral infection
a child is infected by virus only
|
a child is infected by virus only
|
|
viral and bacterial infection
a child is infected by virus and progress to bacterial infection
|
a child is infected by virus and progress to bacterial infection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
level of lactate
Time Frame: three days after admission
|
level of lactate in both viral and viral and bacterial infection groups
|
three days after admission
|
|
the level of lactate dehydrogenase(LDH)
Time Frame: three days after admission
|
level of LDH in both viral and viral and bacterial infection groups
|
three days after admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
March 31, 2023
Study Registration Dates
First Submitted
February 26, 2021
First Submitted That Met QC Criteria
March 1, 2021
First Posted (Actual)
March 2, 2021
Study Record Updates
Last Update Posted (Actual)
May 1, 2023
Last Update Submitted That Met QC Criteria
April 28, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- lactate for infection
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
two years after the study accomplishment
IPD Sharing Time Frame
from Jan-1, 2025 to Dec-31, 2025
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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