Chronic Obstructive Pulmonary DiseaseNCT03923803
Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Assiut University.
Trial summary
Chronic obstructive pulmonary disease is a serious disease . Exacerbations of Chronic obstructive pulmonary disease is an acute worsening condition of Chronic obstructive pulmonary disease, which always accompanied by clinical symptoms such as, shortness of breath and increased production of sputum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- C- reactive protein and Pro calcitonin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acutely exacerbated chronic obstructive pulmonary disease
Who may be able to join
- Patients admitted to the hospital
Who cannot join
- patients with malignancies
- patients with other systemic infection
Trial locations and contacts
No sites are listed yet.
About this study
Chronic obstructive pulmonary disease is a serious disease . Exacerbations of Chronic obstructive pulmonary disease is an acute worsening condition of Chronic obstructive pulmonary disease, which always accompanied by clinical symptoms such as, shortness of breath and increased production of sputum. Respiratory infection (bacteria or viruses or mixed) is thought to be the main cause in most exacerbations.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- C- reactive protein, Pro calcitonin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C- reactive proteinDiagnostic test
the measurement will be done by chemileumeniscence
Pro calcitoninDiagnostic test
the measurement will be done by chemileumeniscence
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease | patients with acutely exacerbated Chronic obstructive pulmonary disease admitted in chest department Assiut university hospital ,30 patients who revealed sputum culture and inflammatory markers suggesting infection exacerbation will be followed up Receives: Diagnostic Test: C- reactive protein; Diagnostic Test: Pro calcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of C-reactive protein between Infection and Non-infectious inflammatory response in acute exacerbations of Chronic obstructive pulmonary disease patients
Patients will be classified into cases with Infection or non-infectious inflammatory response according to the level of C-reactive protein
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study startJul 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Ismail Moussa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923803
- Sponsor's protocol ID
- CRPPC
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03923803
- Acronym / sponsor ID
- CRPPC
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 23 Apr 2019 (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.
Chronic obstructive pulmonary disease is a serious disease . Exacerbations of Chronic obstructive pulmonary disease is an acute worsening condition of Chronic obstructive pulmonary disease, which always accompanied by clinical symptoms such as, shortness of breath and increased production of sputum. Respiratory infection (bacteria or viruses or mixed) is thought to be the main cause in most exacerbations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease | – | Diagnostic Test: C- reactive protein, Diagnostic Test: Pro calcitoninpatients with acutely exacerbated Chronic obstructive pulmonary disease admitted in chest department Assiut university hospital ,30 patients who revealed sputum culture and inflammatory markers suggesting infection exacerbation will be followed up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acutely exacerbated chronic obstructive pulmonary disease
Key inclusion criteria (1 listed)
- Patients admitted to the hospital
Key exclusion criteria (2 listed)
- patients with malignancies
- patients with other systemic infection
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 |
|---|---|---|
| C- reactive proteinthe measurement will be done by chemileumeniscence | Diagnostic test | Chronic obstructive pulmonary disease |
| Pro calcitoninthe measurement will be done by chemileumeniscence | Diagnostic test | Chronic obstructive pulmonary disease |
Primary outcome
The level of C-reactive protein between Infection and Non-infectious inflammatory response in acute exacerbations of Chronic obstructive pulmonary disease patients
Time frame: 24 hours
Patients will be classified into cases with Infection or non-infectious inflammatory response according to the level of C-reactive protein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan Omar, MD (01223971654, hananomar1962@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of C-reactive protein between Infection and Non-infectious inflammatory response in acute exacerbations of Chronic obstructive pulmonary disease patients (time frame: 24 hours). 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 23 Apr 2019.