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Completed

NCT Number: NCT06546982

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

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.

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Key information

Conditions

Typhoid Fever Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Salmonella Infections

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roger Molto Pallares

Aachen, Northwest, 52074, Germany

About this study

This study on the clinical application of surface-enhanced Raman spectroscopy (SERS) is composed of two parts. First, a SERS measurement protocol will be developed to enhance the interactions between gold nanoparticles and the components of the patients samples, maximizing Raman spectroscopical signatures. Given the complex composition of human blood, which encompasses numerous biological constituents, the study focuses on serum, a component obtained through centrifugation after the removal of cells and clotting factors. Fifteen spectra will be recorded per sample. The raw spectra will be post-processed, including removal of the substrate signal, baseline correction, vector normalization, and smoothing steps.

The SERS measurement protocol established in the first section will subsequently be applied to samples of healthy and typhoid fever patients. The samples from infected patients will be confirmed with the Widal test. Multivariate data analysis will be performed to identify distinctive feature characteristics in the samples that correlate to their group (healthy and infected patients), allowing patient diagnosis, as well as the severity of the infection.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Patients with severe concurrent diseases were excluded from the study

Treatment and study plan

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.

Primary outcomes

  1. SERS measurements to differentiate between healthy and typhoid fever patients

    Time frame: Through study competition, up to 1 year

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

Secondary outcomes

  1. SERS measurements to stage typhoid fever patients

    Time frame: Through study competition, up to 1 year

    SERS assessment of early-stage and consolidated-stage typhoid fever patient samples to identify unique spectroscopical characteristics to stage the infection.

Sponsors and collaborators

Lead sponsor

University Hospital, Aachen

Other

Collaborators

  • Nishtar Medical University
  • University of Agriculture Faisalabad

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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