Lower Respiratory Tract and Lung InfectionsNCT06211985
Copeptin: Disease Severity Indicator
A study testing Copeptin level measurement in people with Lower Respiratory Tract and Lung Infections and Ventilator Lung, run by Berker Okay at 1 site in Turkey (Türkiye).
Trial summary
Copeptin serves as a biomarker emanating from the pituitary gland, functioning as the precursor to arginine vasopressin (AVP). Its role in the regulation of endothelial dysfunction, inflammation, and water-electrolyte balance has been established. Read more about this study
- Who is it for?
- Ages 1 month to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Respiratory Tract and Lung Infections, Ventilator Lung, Bronchopneumonia
- What is being tested?
- Copeptin level measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2023to 2 Nov 2023
- Phase
- Interventional
- 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 month to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being diagnosed with pneumonia,
- The family must have given informed consent for the study.
Who cannot join
- Individuals with underlying lung conditions (such as cystic fibrosis, bronchopulmonary dysplasia, asthma, bronchiectasis, tuberculosis),
- Individuals with underlying chronic illnesses (inclusive of heart, kidney, liver, gastrointestinal, and endocrine disorders),
- Individuals with obesity or malnutrition,
- Individuals with hyponatremia detected in their tests,
- Individuals with signs of dehydration,
- Individuals with a history of hospitalization within the last 72 hours.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
UHS Haseki Training and Research Hospital
Istanbul, Sultangazi, 34304
About this study
Official title: Copeptın as a Dısease Severıty Indıcator: A Prospectıve Case-Control Study
Copeptin serves as a biomarker emanating from the pituitary gland, functioning as the precursor to arginine vasopressin (AVP). Its role in the regulation of endothelial dysfunction, inflammation, and water-electrolyte balance has been established. The measurement of AVP levels poses challenges due to its brief half-life and the intricate nature of its detection method. In contrast, copeptin provides an indirect means of gauging circulating AVP levels, as it can be conveniently assessed through a sandwich immunoassay. As a neuroendocrine stress hormone, copeptin emerges as a prognostic indicator, reflective of an individual's stress burden. Moreover, its applicability extends to various acute conditions such as ischemic stroke or myocardial infarction. Notably, copeptin proves to be a dependable tool in the differential diagnosis of diverse ailments characterized by polyuria and polydipsia.
Lower respiratory tract infection (LRTI) stands as the predominant cause of morbidity and mortality among children and adolescents globally. Notably, copeptin has demonstrated utility in forecasting the severity and complications associated with severe pneumonia in adults. While early investigations into copeptin's role in pediatric LRTI suggest its potential for diagnosing pneumonia and predicting complications, the outcomes of these studies present conflicting results.
Although there has been a notable increase in studies on copeptin in pediatric patients over the past decade, research specifically exploring its correlation with pneumonia remains scarce. This prospective case-control study is designed to investigate the potential association between copeptin levels and the severity of illness in pediatric patients with pneumonia. The study aims to determine whether copeptin levels can serve as a reliable predictor of disease severity in pneumonia, offering valuable insights for clinical application. The outcomes of this research may contribute significantly to our comprehension of copeptin's role in disease prognosis and management, thereby facilitating the development of more efficacious diagnostic and therapeutic approaches. Additionally, the study seeks to identify the factors influencing copeptin levels and establish a cut-off value for copeptin in pediatric patients diagnosed with pneumonia.
- Conditions
- Lower Respiratory Tract and Lung Infections, Ventilator Lung, Bronchopneumonia, Bronchitis
- Being tested
- Copeptin level measurement
- Medical subject headings
- Bronchopneumonia, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copeptin level measurementDiagnostic test
Throughout the study period, a total of 202 eligible patients were admitted to the hospital. Twenty-four patients were excluded due to lack of consent from their families, and an additional 103 patients were excluded based on the predefined exclusion criteria. In the control group, 72 individuals without chronic or acute diseases were initially eligible, but 46 of them were excluded due to lack of consent from their families. The study included patients who met the inclusion criteria and whose families provided consent, and it concluded upon reaching a total of 25 patients for each group. Additional blood samples were collected from each child within every group to assess copeptin levels, in conjunction with routine tests
| Study group | Role | What they receive |
|---|---|---|
| Bronchiolitis Group | Active comparator | patients admitted to the ward with a diagnosis of Bronchiolitis (Group 1) Receives: Diagnostic Test: Copeptin level measurement |
| Mild to Moderate Pneumonia Group | Active comparator | patients admitted to the ward with a diagnosis of mild to moderate pneumonia (Group 2) Receives: Diagnostic Test: Copeptin level measurement |
| Severe Pneumonia Group | Active comparator | patients admitted to the ward with a diagnosis of severe pneumonia (Group 2) Receives: Diagnostic Test: Copeptin level measurement |
| Control Group | Active comparator | the control group without pneumonia (Group 4) Receives: Diagnostic Test: Copeptin level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict disease severity in children with pneumonia with copeptin
Copeptin may hold promise as a predictor of disease severity in children with lower respiratory tract infections. It may show potential to guide physicians in determining the need for hospitalization and ventilator support.
To measure this, patients were divided into groups and copeptin values of patients who needed ventilator support or who were hospitalized were compared with copeptin values of others using SPSS statistical program.
Measured: 1 months
Secondary outcomes (1)
Copeptin is more powerful than other acute phase reactants in predicting disease severity.
Copeptinin may perform better than other acute phase reactants such as neutrophil to lymphocyte ratio, fibrinogen to albumin ratio, c-reactive protein and procalcitonin in indicating the severity of the disease.
To measure this, patients were divided into groups and copeptin values of patients who needed ventilator support or who were hospitalized were compared with copeptin values of others using SPSS statistical program.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start12 Apr 2023
- Primary completion2 Oct 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract and Lung InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Blood tests were taken from all children included in the study to study the biomarker called 'Copeptin'.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berker Okay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berker Okay, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211985
- Sponsor's protocol ID
- 63-2023
- Status last verified
- May 2024
- First submitted
- 23 Dec 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Du JM, Sang G, Jiang CM, He XJ, Han Y. Relationship between plasma copeptin levels and complications of community-acquired pneumonia in preschool children. Peptides. 2013 Jul;45:61-5. doi: 10.1016/j.peptides.2013.04.015. Epub 2013 May 6.
PubMed 23659862Mohamed GB, Saed MA, Abdelhakeem AA, Salah K, Saed AM. Predictive value of copeptin as a severity marker of community-acquired pneumonia. Electron Physician. 2017 Jul 25;9(7):4880-4885. doi: 10.19082/4880. eCollection 2017 Jul.
PubMed 28894549Abdel-Fattah M, Meligy B, El-Sayed R, El-Naga YA. Serum Copeptin Level as a Predictor of Outcome in Pneumonia. Indian Pediatr. 2015 Sep;52(9):807-8. doi: 10.1007/s13312-015-0723-x.
PubMed 26519722Alcoba G, Manzano S, Lacroix L, Galetto-Lacour A, Gervaix A. Proadrenomedullin and copeptin in pediatric pneumonia: a prospective diagnostic accuracy study. BMC Infect Dis. 2015 Aug 19;15:347. doi: 10.1186/s12879-015-1095-5.
PubMed 26286191Wrotek A, Jackowska T, Pawlik K. Sodium and copeptin levels in children with community acquired pneumonia. Adv Exp Med Biol. 2015;835:31-6. doi: 10.1007/5584_2014_41.
PubMed 25252899Baumann P, Fuchs A, Gotta V, Ritz N, Baer G, Bonhoeffer JM, Buettcher M, Heininger U, Szinnai G, Bonhoeffer J; ProPAED study group. The kinetic profiles of copeptin and mid regional proadrenomedullin (MR-proADM) in pediatric lower respiratory tract infections. PLoS One. 2022 Mar 10;17(3):e0264305. doi: 10.1371/journal.pone.0264305. eCollection 2022.
PubMed 35271609
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptın as a Dısease Severıty Indıcator: A Prospectıve Case-Control Study
- ClinicalTrials.gov ID
- NCT06211985
- Acronym / sponsor ID
- 63-2023
- Conditions
- Lower Respiratory Tract and Lung Infections, Ventilator Lung, Bronchopneumonia, Bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Berker OkayUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 18 Jan 2024 (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.
Copeptin serves as a biomarker emanating from the pituitary gland, functioning as the precursor to arginine vasopressin (AVP). Its role in the regulation of endothelial dysfunction, inflammation, and water-electrolyte balance has been established. The measurement of AVP levels poses challenges due to its brief half-life and the intricate nature of its detection method. In contrast, copeptin provides an indirect means of gauging circulating AVP levels, as it can be conveniently assessed through a sandwich immunoassay. As a neuroendocrine stress hormone, copeptin emerges as a prognostic indicator, reflective of an individual's stress burden. Moreover, its applicability extends to various acute conditions such as ischemic stroke or myocardial infarction. Notably, copeptin proves to be a dependable tool in the differential diagnosis of diverse ailments characterized by polyuria and polydipsia.
Lower respiratory tract infection (LRTI) stands as the predominant cause of morbidity and mortality among children and adolescents globally. Notably, copeptin has demonstrated utility in forecasting the severity and complications associated with severe pneumonia in adults. While early investigations into copeptin's role in pediatric LRTI suggest its potential for diagnosing pneumonia and predicting complications, the outcomes of these studies present conflicting results.
Although there has been a notable increase in studies on copeptin in pediatric patients over the past decade, research specifically exploring its correlation with pneumonia remains scarce. This prospective case-control study is designed to investigate the potential association between copeptin levels and the severity of illness in pediatric patients with pneumonia. The study aims to determine whether copeptin levels can serve as a reliable predictor of disease severity in pneumonia, offering valuable insights for clinical application. The outcomes of this research may contribute significantly to our comprehension of copeptin's role in disease prognosis and management, thereby facilitating the development of more efficacious diagnostic and therapeutic approaches. Additionally, the study seeks to identify the factors influencing copeptin levels and establish a cut-off value for copeptin in pediatric patients diagnosed with pneumonia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Blood tests were taken from all children included in the study to study the biomarker called 'Copeptin'.
| Arm | Type | Receives |
|---|---|---|
| Bronchiolitis Group | Active comparator | Diagnostic Test: Copeptin level measurementpatients admitted to the ward with a diagnosis of Bronchiolitis (Group 1) |
| Mild to Moderate Pneumonia Group | Active comparator | Diagnostic Test: Copeptin level measurementpatients admitted to the ward with a diagnosis of mild to moderate pneumonia (Group 2) |
| Severe Pneumonia Group | Active comparator | Diagnostic Test: Copeptin level measurementpatients admitted to the ward with a diagnosis of severe pneumonia (Group 2) |
| Control Group | Active comparator | Diagnostic Test: Copeptin level measurementthe control group without pneumonia (Group 4) |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Being diagnosed with pneumonia,
- The family must have given informed consent for the study.
Key exclusion criteria (6 listed)
- Individuals with underlying lung conditions (such as cystic fibrosis, bronchopulmonary dysplasia, asthma, bronchiectasis, tuberculosis),
- Individuals with underlying chronic illnesses (inclusive of heart, kidney, liver, gastrointestinal, and endocrine disorders),
- Individuals with obesity or malnutrition,
- Individuals with hyponatremia detected in their tests,
- Individuals with signs of dehydration,
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 |
|---|---|---|
| Copeptin level measurementThroughout the study period, a total of 202 eligible patients were admitted to the hospital. Twenty-four patients were excluded due to lack of consent from their families, and an additional 103 patients were excluded based on the predefined exclusion criteria. In the control group, 72 individuals without chronic or acute diseases were initially eligible, but 46 of them were excluded due to lack of consent from their families. The study included patients who met the inclusion criteria and whose families provided consent, and it concluded upon reaching a total of 25 patients for each group. Additional blood samples were collected from each child within every group to assess copeptin levels, in conjunction with routine tests | Diagnostic test | Bronchiolitis Group, Control Group, Mild to Moderate Pneumonia Group, Severe Pneumonia Group |
Primary outcome
Predict disease severity in children with pneumonia with copeptin
Time frame: 1 months
Copeptin may hold promise as a predictor of disease severity in children with lower respiratory tract infections. It may show potential to guide physicians in determining the need for hospitalization and ventilator support. To measure this, patients were divided into groups and copeptin values of patients who needed ventilator support or who were hospitalized were compared with copeptin values of others using SPSS statistical program.
1 secondary outcome
Copeptin is more powerful than other acute phase reactants in predicting disease severity.
Time frame: 1 months
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 30 May 2024.
- Background: PubMed 23659862Du JM, Sang G, Jiang CM, He XJ, Han Y. Relationship between plasma copeptin levels and complications of community-acquired pneumonia in preschool children. Peptides. 2013 Jul;45:61-5. doi: 10.1016/j.peptides.2013.04.015. Epub 2013 May 6.
- Background: PubMed 28894549Mohamed GB, Saed MA, Abdelhakeem AA, Salah K, Saed AM. Predictive value of copeptin as a severity marker of community-acquired pneumonia. Electron Physician. 2017 Jul 25;9(7):4880-4885. doi: 10.19082/4880. eCollection 2017 Jul.
- Background: PubMed 26519722Abdel-Fattah M, Meligy B, El-Sayed R, El-Naga YA. Serum Copeptin Level as a Predictor of Outcome in Pneumonia. Indian Pediatr. 2015 Sep;52(9):807-8. doi: 10.1007/s13312-015-0723-x.
- Background: PubMed 26286191Alcoba G, Manzano S, Lacroix L, Galetto-Lacour A, Gervaix A. Proadrenomedullin and copeptin in pediatric pneumonia: a prospective diagnostic accuracy study. BMC Infect Dis. 2015 Aug 19;15:347. doi: 10.1186/s12879-015-1095-5.
- Background: PubMed 25252899Wrotek A, Jackowska T, Pawlik K. Sodium and copeptin levels in children with community acquired pneumonia. Adv Exp Med Biol. 2015;835:31-6. doi: 10.1007/5584_2014_41.
- Background: PubMed 35271609Baumann P, Fuchs A, Gotta V, Ritz N, Baer G, Bonhoeffer JM, Buettcher M, Heininger U, Szinnai G, Bonhoeffer J; ProPAED study group. The kinetic profiles of copeptin and mid regional proadrenomedullin (MR-proADM) in pediatric lower respiratory tract infections. PLoS One. 2022 Mar 10;17(3):e0264305. doi: 10.1371/journal.pone.0264305. eCollection 2022.
- Individual participant dataSharing planned: No
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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?
A study testing Copeptin level measurement in people with Lower Respiratory Tract and Lung Infections and Ventilator Lung, run by Berker Okay at 1 site in Turkey (Türkiye).
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 6 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 30 May 2024. 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 Turkey (Türkiye). 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?
Predict disease severity in children with pneumonia with copeptin (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211985, which also lists 6 linked publications.
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 30 May 2024.