Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy

NCT06546982 | Completed

• 1 other identifier: Typhoid Fever SERS 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to adapt the gold nanoparticle-based surface-enhanced Raman spectroscopy (SERS) technology to clinical application. In this exploratory study a measurement protocol will be established to subsequently investigate whether SERS allows to diagnose patients infected with typhoid fever as well as to stage the disease.

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (1)

• SERS measurements to differentiate between healthy and typhoid fever patients

  SERS assessment of healthy and typhoid fever patient samples to identify unique spectroscopical characteristics to discriminate between healthy and typhoid fever patients

  Through study competition, up to 1 year

Secondary Outcomes (1)

• SERS measurements to stage typhoid fever patients

  Through study competition, up to 1 year

Study Arms (3)

Healthy

EXPERIMENTAL

The serum samples of healthy patients will be measured.

Diagnostic Test: Surface-enhanced Raman Spectroscopy

Early-stage typhoid fever

EXPERIMENTAL

The serum samples of early-stage typhoid fever patients will be measured.

Diagnostic Test: Surface-enhanced Raman Spectroscopy

Consolidated-stage typhoid fever

EXPERIMENTAL

The serum samples of consolidated-stage typhoid fever patients will be measured.

Diagnostic Test: Surface-enhanced Raman Spectroscopy

Interventions

Surface-enhanced Raman Spectroscopy DIAGNOSTIC_TEST

The Raman spectra of patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

Consolidated-stage typhoid fever; Early-stage typhoid fever; Healthy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at Nishtar Medical University
• The age range of the patients was from 18 to 70 years
• Confirmed disease with the Widal test (for typhoid fever groups)

You may not qualify if:

• Patients with severe concurrent diseases were excluded from the study

Sponsors & Collaborators

• University Hospital, Aachen: lead
• University of Agriculture Faisalabad: collaborator
• Nishtar Medical University: collaborator

Study Sites (1)

Roger Molto Pallares

Aachen, Northwest, 52074, Germany

Location

Related Publications (1)

• Ditta A, Zhang R, Nawaz H, Majeed MI, He S, Zhuang Z, Rutten S, Shahzadi A, Yaseen S, Kiessling F, Hu J, Lammers T, Pallares RM. An exploratory clinical study of the diagnosis and staging of typhoid fever using label-free surface-enhanced Raman spectroscopy liquid biopsy. Spectrochim Acta A Mol Biomol Spectrosc. 2025 May 15;333:125864. doi: 10.1016/j.saa.2025.125864. Epub 2025 Feb 4.

  PMID: 39938329 RESULT

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group Leader

Model Details: Spectroscopic assessment of serum samples from healthy and typhoid fever patients to identify characteristics for diagnosis and staging.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 9, 2024
• Study Start: July 15, 2023
• Primary Completion: August 15, 2024
• Study Completion: December 15, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)