Typhoid FeverNCT05579821
Evaluation Study of DPP® Typhoid Assay
An observational study of Typhoid Fever, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Pakistan.
Trial summary
Fever management is a major problem in Low and Middle Income Countries (LMICs) where access to good quality diagnostic test is often unavailable. Fever due to typhoid is similar to other undifferentiated febrile illnesses and typhoid can be mistaken with other vector borne febrile illnesses such as scrub typhus. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- Typhoid DPP assay
- How many people
- 387 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2022to 30 Jun 2023
- 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 2 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: The study will be conducted at AKU research laboratory using well characterized typhoid positive and typhoid negative serum samples, which were archived for further research purposes from previous trial "Comparative study of commercially available typhoid point of care tests to benchmark current and emerging tools" conducted at AKU in 2020-2021. Precisely, the population is represented by children and adults (age 2-65) who presented with fever of 3-7 days duration. All patients from whom these samples were obtained have consented to store their sample at AKU and to use them for research on diagnostic tool for fever management. Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, is not permitted.
Who may be able to join
- Inclusion criteria identical to the prior prospective study in AKU (Protocol ref number: FE006)
- Serum stored frozen at AKU as a part of afore mentioned study and cold-chain maintained.
Who cannot join
- Samples whose reference standard data (Blood culture report) are not available in FIND's OpenClinica database.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of DPP® Typhoid Assay (Chembio Diagnostic System, Inc) for the Diagnosis of Typhoid From Well Characterized Serum Sample.
Fever management is a major problem in Low and Middle Income Countries (LMICs) where access to good quality diagnostic test is often unavailable. Fever due to typhoid is similar to other undifferentiated febrile illnesses and typhoid can be mistaken with other vector borne febrile illnesses such as scrub typhus. Currently available diagnostic tests, blood and bone marrow culture, and RDTs have several limitations including a low sensitivity and specificity . Recently, several antigens of Salmonella Typhi useful for serodiagnosis of typhoid has been identified. Salmonella Typhi lipopolysaccharide (LPS) and hemolysin E (HlyE) have been identified as top candidate antigens by several studies to differentiate acute typhoid patients from healthy individuals. DPP® Typhoid Assay is a multiplex rapid test that detects IgA antibodies to LPS and HlyE antigen. It is considered to have high sensitivity and specificity and its results were found to be highly correlated with ELISA results. However, very few studies have been conducted to evaluate this test and limited information about the accuracy of this test is present. Hence, this study will evaluate the sensitivity and specificity of this test in archived serum sample of well characterized blood culture positives and negatives in support of new innovation on typhoid diagnostics.
Read the detailed description
Typhoid is an acute febrile illness caused by Salmonella enterica serovar Typhi (S. Typhi). Annually, an estimated 11-21 million people become infected with typhoid fever and 128000-161000 people die from the disease . It is commonly transmitted through consumption of contaminated food or water. Low and middle-income countries and areas with poor access to safe water, food and sanitation are at higher risk of infection.
Blood and bone marrow culture is considered as the mainstay for laboratory confirmation of typhoid. However, it is expensive, requires specific laboratory equipment and technical expertise and takes longer time to generate results. Several RDTs and Widal test are available which do not require specialized laboratory and well-trained staff but lack sensitivity and specificity. Several studies have been done for identification of promising antigens that can be used to develop an accurate serodiagnostic assay. S. Typhi lipopolysaccharide (LPS) and hemolysin E (HlyE) have been identified as top candidate antigens by several studies to differentiate acute typhoid patients from healthy individuals. HlyE is a pore-forming toxin that affects bacterial growth within human macrophages and contributes to the cytotoxicity and invasion of epithelial cells.
Dual Path Platform (DPP) Typhoid Assay of Chembio is a point-of-care (POC) immunochromatographic technology which has the capability of measuring IgA response in blood, plasma and serum to both LPS and HlyE. A previous study done on this POC showed promising sensitivity and specificity to diagnose typhoid.Thus, the current study aims to assess the sensitivity and specificity of DPP ® Typhoid Assay using blood culture as the reference point.
- Conditions
- Typhoid Fever
- Being tested
- Typhoid DPP assay
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typhoid DPP assayDiagnostic test
The index test used in this study diagnose typhoid fever by detecting IgA antibodies against LPS and HlyE antigen in patient's serum.
What is being measured
The primary outcome is the main question the study is designed to answer.
Point estimates of sensitivity and specificity with 95% confidence interval of DPP Typhoid assay using blood culture as reference standard
Measured: October 2022
Secondary outcomes (1)
Estimates of operational characteristics of DPP Typhoid Assay, based on quantitative assessment including invalid rates
Measured: Nov 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start15 Sep 2022
- Primary completion30 Nov 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579821
- Sponsor's protocol ID
- FE006C
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DPP® Typhoid Assay (Chembio Diagnostic System, Inc) for the Diagnosis of Typhoid From Well Characterized Serum Sample.
- ClinicalTrials.gov ID
- NCT05579821
- Acronym / sponsor ID
- FE006C
- Conditions
- Typhoid Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Oct 2022 (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.
Fever management is a major problem in Low and Middle Income Countries (LMICs) where access to good quality diagnostic test is often unavailable. Fever due to typhoid is similar to other undifferentiated febrile illnesses and typhoid can be mistaken with other vector borne febrile illnesses such as scrub typhus. Currently available diagnostic tests, blood and bone marrow culture, and RDTs have several limitations including a low sensitivity and specificity . Recently, several antigens of Salmonella Typhi useful for serodiagnosis of typhoid has been identified. Salmonella Typhi lipopolysaccharide (LPS) and hemolysin E (HlyE) have been identified as top candidate antigens by several studies to differentiate acute typhoid patients from healthy individuals. DPP® Typhoid Assay is a multiplex rapid test that detects IgA antibodies to LPS and HlyE antigen. It is considered to have high sensitivity and specificity and its results were found to be highly correlated with ELISA results. However, very few studies have been conducted to evaluate this test and limited information about the accuracy of this test is present. Hence, this study will evaluate the sensitivity and specificity of this test in archived serum sample of well characterized blood culture positives and negatives in support of new innovation on typhoid diagnostics.
Detailed description
Typhoid is an acute febrile illness caused by Salmonella enterica serovar Typhi (S. Typhi). Annually, an estimated 11-21 million people become infected with typhoid fever and 128000-161000 people die from the disease . It is commonly transmitted through consumption of contaminated food or water. Low and middle-income countries and areas with poor access to safe water, food and sanitation are at higher risk of infection.
Blood and bone marrow culture is considered as the mainstay for laboratory confirmation of typhoid. However, it is expensive, requires specific laboratory equipment and technical expertise and takes longer time to generate results. Several RDTs and Widal test are available which do not require specialized laboratory and well-trained staff but lack sensitivity and specificity. Several studies have been done for identification of promising antigens that can be used to develop an accurate serodiagnostic assay. S. Typhi lipopolysaccharide (LPS) and hemolysin E (HlyE) have been identified as top candidate antigens by several studies to differentiate acute typhoid patients from healthy individuals. HlyE is a pore-forming toxin that affects bacterial growth within human macrophages and contributes to the cytotoxicity and invasion of epithelial cells.
Dual Path Platform (DPP) Typhoid Assay of Chembio is a point-of-care (POC) immunochromatographic technology which has the capability of measuring IgA response in blood, plasma and serum to both LPS and HlyE. A previous study done on this POC showed promising sensitivity and specificity to diagnose typhoid.Thus, the current study aims to assess the sensitivity and specificity of DPP ® Typhoid Assay using blood culture as the reference point.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted at AKU research laboratory using well characterized typhoid positive and typhoid negative serum samples, which were archived for further research purposes from previous trial "Comparative study of commercially available typhoid point of care tests to benchmark current and emerging tools" conducted at AKU in 2020-2021. Precisely, the population is represented by children and adults (age 2-65) who presented with fever of 3-7 days duration. All patients from whom these samples were obtained have consented to store their sample at AKU and to use them for research on diagnostic tool for fever management. Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, is not permitted.
Key inclusion criteria (2 listed)
- Inclusion criteria identical to the prior prospective study in AKU (Protocol ref number: FE006)
- Serum stored frozen at AKU as a part of afore mentioned study and cold-chain maintained.
Key exclusion criteria (1 listed)
- Samples whose reference standard data (Blood culture report) are not available in FIND's OpenClinica database.
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 |
|---|---|---|
| Typhoid DPP assayThe index test used in this study diagnose typhoid fever by detecting IgA antibodies against LPS and HlyE antigen in patient's serum. | Diagnostic test | – |
Primary outcome
Point estimates of sensitivity and specificity with 95% confidence interval of DPP Typhoid assay using blood culture as reference standard
Time frame: October 2022
1 secondary outcome
Estimates of operational characteristics of DPP Typhoid Assay, based on quantitative assessment including invalid rates
Time frame: Nov 2022
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 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Typhoid Fever, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Pakistan.
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 2 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 21 Nov 2023. 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 Pakistan. 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?
Point estimates of sensitivity and specificity with 95% confidence interval of DPP Typhoid assay using blood culture as reference standard (time frame: October 2022). 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 21 Nov 2023.