Typhoid FeverNCT06546982
Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy
A study testing Surface-enhanced Raman Spectroscopy in people with Typhoid Fever, run by University Hospital, Aachen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- Surface-enhanced Raman Spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2023to 15 Dec 2024
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients with severe concurrent diseases were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Typhoid Fever
- Being tested
- Surface-enhanced Raman Spectroscopy
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface-enhanced Raman SpectroscopyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | The serum samples of healthy patients will be measured. Receives: Diagnostic Test: Surface-enhanced Raman Spectroscopy |
| Early-stage typhoid fever | Experimental | The serum samples of early-stage typhoid fever patients will be measured. Receives: Diagnostic Test: Surface-enhanced Raman Spectroscopy |
| Consolidated-stage typhoid fever | Experimental | The serum samples of consolidated-stage typhoid fever patients will be measured. Receives: Diagnostic Test: Surface-enhanced Raman Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study competition, up to 1 year
Secondary outcomes (1)
SERS measurements to stage typhoid fever patients
SERS assessment of early-stage and consolidated-stage typhoid fever patient samples to identify unique spectroscopical characteristics to stage the infection.
Measured: Through study competition, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Jul 2023
- Primary completion15 Aug 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Typhoid FeverStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Spectroscopic assessment of serum samples from healthy and typhoid fever patients to identify characteristics for diagnosis and staging.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aachen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Agriculture Faisalabad, Nishtar Medical University
- Responsible party
- Principal investigator, Roger Molto Pallares, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546982
- Sponsor's protocol ID
- Typhoid Fever SERS 01
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study results will be published in at least one scientific article.
Publications
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.
PubMed 39938329
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Staging of Typhoid Fever Using Surface-enhanced Raman Spectroscopy Liquid Biopsy
- ClinicalTrials.gov ID
- NCT06546982
- Acronym / sponsor ID
- Typhoid Fever SERS 01
- Conditions
- Typhoid Fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, AachenUniversity, hospital or other
- Collaborators
- University of Agriculture Faisalabad, Nishtar Medical University
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 9 Aug 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Spectroscopic assessment of serum samples from healthy and typhoid fever patients to identify characteristics for diagnosis and staging.
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Diagnostic Test: Surface-enhanced Raman SpectroscopyThe serum samples of healthy patients will be measured. |
| Early-stage typhoid fever | Experimental | Diagnostic Test: Surface-enhanced Raman SpectroscopyThe serum samples of early-stage typhoid fever patients will be measured. |
| Consolidated-stage typhoid fever | Experimental | Diagnostic Test: Surface-enhanced Raman SpectroscopyThe serum samples of consolidated-stage typhoid fever patients will be measured. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients with severe concurrent diseases were excluded from 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 |
|---|---|---|
| Surface-enhanced Raman SpectroscopyThe 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. | Diagnostic test | Consolidated-stage typhoid fever, Early-stage typhoid fever, Healthy |
Primary outcome
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
1 secondary outcome
SERS measurements to stage typhoid fever patients
Time frame: Through study competition, up to 1 year
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 5 Mar 2025.
- Results publication: PubMed 39938329Ditta 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.
- Individual participant dataSharing planned: No. The study results will be published in at least one scientific article.
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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.
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?
A study testing Surface-enhanced Raman Spectroscopy in people with Typhoid Fever, run by University Hospital, Aachen at 1 site in Germany.
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 1 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 5 Mar 2025. 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 Germany. 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?
SERS measurements to differentiate between healthy and typhoid fever patients (time frame: Through study competition, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546982, which also lists 1 linked publication.
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 5 Mar 2025.