Diagnostic RoleNCT07791030
Diagnostic and Prognostic Roles of Procalcitonin and Highly Sensitive C-Reactive Protein in Early Detection of Burn Sepsis
An observational study of Diagnostic Role and Prognostic Role, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the value of procalcitonin and highly sensitive c-reactive protein as biomarkers for early detection of sepsis in patients with major burns. Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Diagnostic Role, Prognostic Role, Procalcitonin
- What is being tested?
- Measurement of Procalcitonin level and Measurement of c-reactive protein level
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Jul 2026
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is prospective study will include a total number of 30 patients with major burn. These patients will be admitted to Plastic, Reconstructive and Burn surgery center at Mansoura University from July 2025 to July 2026.
Who may be able to join
- Age from 3 years to 65 years.
- Both sexes.
- Patients with major burn (2nd and 3rd degrees of burn).
Who cannot join
- Patients with unrealistic expectations.
- Patients with inhalational burn injury.
- Patients with uncompensated chronic disease e.g. hepatic, renal.
- Patients with mental or psychological troubles affecting the study
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the value of procalcitonin and highly sensitive c-reactive protein as biomarkers for early detection of sepsis in patients with major burns.
Read the detailed description
Severe burn injuries can cause a marked inflammatory stress response. As the inflammatory state progresses, pro-inflammatory cytokines are continuously released.
C reactive protein (CRP) is closely related to the systemic inflammation in its acute phase, as CRP binds to the damaged cell membranes that associates burn injuries and contributes to the associated inflammatory response.
Procalcitonin (PCT) a precursor protein for calcitonin, which is synthesized by thyroid C-cells, is yet another biomarker valuable in the sepsis diagnosis.
- Conditions
- Diagnostic Role, Prognostic Role, Procalcitonin, Highly Sensitive, C-Reactive Protein, Early Detection
- Being tested
- Measurement of Procalcitonin level, Measurement of c-reactive protein level
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Procalcitonin levelDiagnostic test
Two samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.
Measurement of c-reactive protein levelDiagnostic test
Two samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with major burn (2nd and 3rd degrees of burn) Receives: Diagnostic Test: Measurement of Procalcitonin level; Diagnostic Test: Measurement of c-reactive protein level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of c-reactive protein level
Two samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.
Measured: 5 days of burn injury
Secondary outcomes (1)
Measurement of procalcitonin level
Two samples were collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.
Measured: 5 days of burn injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic RoleStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riwina Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791030
- Sponsor's protocol ID
- MD.25.08.1017
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Roles of Procalcitonin and Highly Sensitive C-Reactive Protein in Early Detection of Burn Sepsis
- ClinicalTrials.gov ID
- NCT07791030
- Acronym / sponsor ID
- MD.25.08.1017
- Conditions
- Diagnostic Role, Prognostic Role, Procalcitonin, Highly Sensitive, C-Reactive Protein, Early Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 27 Aug 2026 (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.
This study aimed to evaluate the value of procalcitonin and highly sensitive c-reactive protein as biomarkers for early detection of sepsis in patients with major burns.
Detailed description
Severe burn injuries can cause a marked inflammatory stress response. As the inflammatory state progresses, pro-inflammatory cytokines are continuously released.
C reactive protein (CRP) is closely related to the systemic inflammation in its acute phase, as CRP binds to the damaged cell membranes that associates burn injuries and contributes to the associated inflammatory response.
Procalcitonin (PCT) a precursor protein for calcitonin, which is synthesized by thyroid C-cells, is yet another biomarker valuable in the sepsis diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Measurement of Procalcitonin level, Diagnostic Test: Measurement of c-reactive protein levelPatients with major burn (2nd and 3rd degrees of burn) |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is prospective study will include a total number of 30 patients with major burn. These patients will be admitted to Plastic, Reconstructive and Burn surgery center at Mansoura University from July 2025 to July 2026.
Key inclusion criteria (3 listed)
- Age from 3 years to 65 years.
- Both sexes.
- Patients with major burn (2nd and 3rd degrees of burn).
Key exclusion criteria (4 listed)
- Patients with unrealistic expectations.
- Patients with inhalational burn injury.
- Patients with uncompensated chronic disease e.g. hepatic, renal.
- Patients with mental or psychological troubles affecting the study
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 |
|---|---|---|
| Measurement of Procalcitonin levelTwo samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days. | Diagnostic test | Study group |
| Measurement of c-reactive protein levelTwo samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days. | Diagnostic test | Study group |
Primary outcome
Measurement of c-reactive protein level
Time frame: 5 days of burn injury
Two samples was collected from each patient, one on admission or within the 1st 24 hours of burn and the 2nd were after 3 days.
1 secondary outcome
Measurement of procalcitonin level
Time frame: 5 days of burn injury
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 27 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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 Diagnostic Role and Prognostic Role, run by Mansoura University at 1 site in Egypt.
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 3 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 27 Aug 2026. 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 Egypt. 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?
Measurement of c-reactive protein level (time frame: 5 days of burn injury). 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 27 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.