NCT07791030

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 days of burn injury

Secondary Outcomes (1)

  • Measurement of procalcitonin level

    5 days of burn injury

Study Arms (1)

Study group

Patients with major burn (2nd and 3rd degrees of burn)

Diagnostic Test: Measurement of Procalcitonin levelDiagnostic Test: Measurement of c-reactive protein level

Interventions

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

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

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age from 3 years to 65 years.
  • Both sexes.
  • Patients with major burn (2nd and 3rd degrees of burn).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Plastic, Reconstructive and Burn Surgery Center, Faculty of Medicine, Mansoura University, Egypt

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

September 1, 2025

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author

Locations