Viral InfectionNCT04777747
The Role of Lactate in Viral and Bacterial Infection
An observational study of Viral Infection and Bacterial Infections, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 18 years
- Conditions the study is for
- Viral Infection, Bacterial Infections, Lactate Blood Increase
- What is being tested?
- viral infection and viral and bacterial infection
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The age of a child ranged from 0 to 18 is included in the present study, especially the first viral infection.
Who may be able to join
- child's age is from 0 to 18 years
- a child is at least diagnosed with viral infection
Who cannot join
- one of the following conditions appeared:
- congenital heart disease or other abnormalities
- respiratory failure
- hereditary and/or metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- viral infection, viral and bacterial infection
- Medical subject headings
- Virus Diseases, Bacterial Infections, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
viral infectionOther
a child is infected by virus only
viral and bacterial infectionOther
a child is infected by virus and progress to bacterial infection
| Study group | Role | What they receive |
|---|---|---|
| viral infection | a child is infected by virus only Receives: Other: viral infection | |
| viral and bacterial infection | a child is infected by virus and progress to bacterial infection Receives: Other: viral and bacterial infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of lactate
level of lactate in both viral and viral and bacterial infection groups
Measured: three days after admission
the level of lactate dehydrogenase(LDH)
level of LDH in both viral and viral and bacterial infection groups
Measured: three days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Chen Long,MD, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777747
- Sponsor's protocol ID
- lactate for infection
- Status last verified
- Oct 2022
- First submitted
- 26 Feb 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: two years after the study accomplishment
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lactate From Viral to Bacterial Infection
- ClinicalTrials.gov ID
- NCT04777747
- Acronym / sponsor ID
- lactate for infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| viral infection | – | Other: viral infectiona child is infected by virus only |
| viral and bacterial infection | – | Other: viral and bacterial infectiona child is infected by virus and progress to bacterial infection |
Who may qualify
- Ages
- 1 minute to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The age of a child ranged from 0 to 18 is included in the present study, especially the first viral infection.
Key inclusion criteria (2 listed)
- child's age is from 0 to 18 years
- a child is at least diagnosed with viral infection
Key exclusion criteria (4 listed)
- congenital heart disease or other abnormalities
- respiratory failure
- hereditary and/or metabolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| viral infectiona child is infected by virus only | Other | viral infection |
| viral and bacterial infectiona child is infected by virus and progress to bacterial infection | Other | viral and bacterial infection |
Primary outcome
level of lactate
Time frame: three days after admission
level of lactate in both viral and viral and bacterial infection groups
the level of lactate dehydrogenase(LDH)
Time frame: three days after admission
level of LDH in both viral and viral and bacterial infection groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Yes. two years after the study accomplishment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Infection and Bacterial Infections, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of lactate (time frame: three days after admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.