AzTrials
AzTrials

Typhoid FeverNCT04673487

Commercial Typhoid Tests Validation

An observational study of Typhoid Fever, run by Kenya Medical Research Institute at 1 site in Kenya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The study aims to perform a head to head comparison of 11 typhoid tests currently in the market and simultaneously develop a sample set that can be used in future evaluations of emerging technologies. Read more about this study

Who is it for?
Ages 8 to 65 years
Conditions the study is for
Typhoid Fever
What is being tested?
1. SD Bioline Salmonella Typhi IgG/IgM Fast test, 2. Typhidot Rapid IgG/IgM combo test, 3. TUBEX TF test, 4.Typhoid IgG/IgM Combo Rapid Test CE, 5. Enterocheck WB test, 6. Test-itTM Typhoid IgM test
How many people
2,000 participants
Where
1 siteKenya
Study dates
Jan 2021to Dec 2021
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 8 to 65 years
  • All sexes
  • Child, Adult, Older adult

Study population: The trial population will be composed of adults and children suspected of typhoid between 8-65 years of age. Participants will be recruited in 3 hospitals in Nairobi, Kenya.The three hospitals are in Nairobi County and include Mbagathi County Hospital, Mbagathi Road; Medical Missionaries of Mary, Reuben Centre Hospital in Mukuru Slum, Embakasi and City Council Clinic in Mukuru Slum, Embakasi.

Who may be able to join

  • Individuals aged 8 years of age to 65 years of age
  • History of fever or axillary temperature of >37.5 °C for at least 3 consecutive days within the last 7 days prior to enrollment
  • Clinical suspicion of enteric fever
  • One of the following scenarios:
  • Presents to outpatient department or Emergency Department
  • Admitted to hospital within last 12 hours
  • Able and willing to provide informed consent (and assent when required)

Who cannot join

  • Unwillingness to participate in the study
  • Inability to provide the required volume of blood
  • Unwillingness to provide blood
  • Known non-infectious / Non typhoid Infectious causes of fever or other alternate diagnosis of fever

Trial locations and contacts

1 site in 1 country.

Robert S Onsare, PhD contact

+254722337004

robert.s.onsare@gmail.com

Kenya1 site

  • Kenya Medical Research Institute

    Nairobi, 254

Other trials in Kenya

About this study

Official title: Comparative Study of Commercially Available Typhoid Point of Care Tests to Benchmark Current and Emerging Tools

The study aims to perform a head to head comparison of 11 typhoid tests currently in the market and simultaneously develop a sample set that can be used in future evaluations of emerging technologies. The central objective is to evaluate different Typhoid Rapid Diagnostic Tests (RDTs) that are commercially available internationally for detecting antigens or antibodies to Salmonella Typhi and use Blood culture as standard for comparison. The end point will be to determine estimates of sensitivity and specificity for each test, with 95% confidence interval, using blood culture as reference.

Read the detailed description

Typhoid fever is an enteric bacterial infection caused by Salmonella enterica serovar Typhi (Salmonella Typhi; S. Typhi). It is an important infectious disease in low- and middle-income countries with over 10.9 million new cases worldwide and 116.8 thousand death in 2017. South Asia and Sub Saharan Africa are the most affected areas of the world. Typhoid fever is common in areas with inadequate sanitation and hygiene. In routine practice, diagnosis of typhoid fever is rarely confirmed as diagnostic tests are unavailable or have limited diagnostic accuracy. Blood culture is the commonest reference standard test but has a lower sensitivity. Alternatives to those methods exist but their performance is poor. The Widal test is still used but as it is based on cross-reactive antigens, it lacks sensitivity and specificity. Clinician often use rapid diagnostic tests to diagnose typhoid. A number of typhoid fever RDTs are commercially available but performance data are not available or not consistent from a study to another. This prospective, multicentre, cross-sectional study will be carried out in 3 hospitals of Nairobi, Kenya. 2000 clinically suspected typhoid cases will be enrolled in this study, blood culture as well as serum for RDT will be received. All typhoid positive and equal typhoid negative serum will be tested for investigational RDTs.

This collaborative study between Kenya Medical Research Institute (KEMRI) and Foundation for Innovative New Diagnostics (FIND) will systematically compare different point of care typhoid tests currently available in the market against the same set of reference standard. The knowledge gained from this trial may benefit health providers' by providing information on diagnostic accuracy of current typhoid test and to decide on utility of these commercial tests. The result obtained from this trial will also be made available to help inform Ministry of Health in Kenya and the World Health Organization (WHO) Essential Diagnostic list (EDL) and stakeholder decision making more broadly.

Conditions
Typhoid Fever
Being tested
1. SD Bioline Salmonella Typhi IgG/IgM Fast test, 2. Typhidot Rapid IgG/IgM combo test, 3. TUBEX TF test, 4.Typhoid IgG/IgM Combo Rapid Test CE, 5. Enterocheck WB test, 6. Test-itTM Typhoid IgM test
Medical subject headings
Typhoid Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1. SD Bioline Salmonella Typhi IgG/IgM Fast test, 2. Typhidot Rapid IgG/IgM combo test, 3. TUBEX TF test, 4.Typhoid IgG/IgM Combo Rapid Test CE, 5. Enterocheck WB test, 6. Test-itTM Typhoid IgM testDiagnostic test

    Also called 7. Typhoid IgG/IgM Rapid Test Cassette 8. S.typhi-S.paratyphi "A" Direct Antigen Detection test 9. DiaquickS.typhi IgG/IgM Ab test 10. Diaquick S. typhi/paratyphi Ag cassette test 11. Widal test.

    Evaluation of 11 different Typhoid Rapid Diagnostic Tests that are commercially available internationally and use Blood culture as standard for comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Point estimates of sensitivity and specificity for each test, with 95% confidence interval, using blood culture as reference standard.

    Evaluation of different Rapid Diagnostic Tests (RDTs) that are commercially available internationally for detecting antigens or antibodies to Salmonella Typhi and use Blood culture as standard for comparison.

    Measured: At the end of the 6-month sampling period

Secondary outcomes (2)

  1. Establishment of a bio repository of well characterized specimen collection at the site available for future assessments of emerging technologies

    Establishment of a bio repository of well characterized specimen collection that can be used to evaluate emerging tests.

    Measured: At the end of the 6-month sampling period

  2. Estimates of operational characteristics of different RDTs based on quantitative assessment including invalid and indeterminate rates

    Evaluation of operational characteristics (invalid and indeterminate rates) of Typhoid RDTs

    Measured: At the end of the 6-month sampling period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study startJan 2021 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673487
Sponsor's protocol ID
SERU 4076
Status last verified
Dec 2020
First submitted
1 Dec 2020
Last updated
17 Dec 2020
Results posted
No

Publications

  • Crump JA. Progress in Typhoid Fever Epidemiology. Clin Infect Dis. 2019 Feb 15;68(Suppl 1):S4-S9. doi: 10.1093/cid/ciy846.

    PubMed 30767000

  • Amicizia D, Micale RT, Pennati BM, Zangrillo F, Iovine M, Lecini E, Marchini F, Lai PL, Panatto D. Burden of typhoid fever and cholera: similarities and differences. Prevention strategies for European travelers to endemic/epidemic areas. J Prev Med Hyg. 2019 Dec 20;60(4):E271-E285. doi: 10.15167/2421-4248/jpmh2019.60.4.1333. eCollection 2019 Dec.

    PubMed 31967084

  • Ayukekbong JA, Ntemgwa M, Atabe AN. The threat of antimicrobial resistance in developing countries: causes and control strategies. Antimicrob Resist Infect Control. 2017 May 15;6:47. doi: 10.1186/s13756-017-0208-x. eCollection 2017.

    PubMed 28515903

  • Hamaguchi S, Cuong NC, Tra DT, Doan YH, Shimizu K, Tuan NQ, Yoshida LM, Mai LQ, Duc-Anh D, Ando S, Arikawa J, Parry CM, Ariyoshi K, Thuy PT. Clinical and Epidemiological Characteristics of Scrub Typhus and Murine Typhus among Hospitalized Patients with Acute Undifferentiated Fever in Northern Vietnam. Am J Trop Med Hyg. 2015 May;92(5):972-978. doi: 10.4269/ajtmh.14-0806. Epub 2015 Mar 16.

    PubMed 25778504

  • Moore CE, Pan-Ngum W, Wijedoru LPM, Sona S, Nga TVT, Duy PT, Vinh PV, Chheng K, Kumar V, Emary K, Carter M, White L, Baker S, Day NPJ, Parry CM. Evaluation of the diagnostic accuracy of a typhoid IgM flow assay for the diagnosis of typhoid fever in Cambodian children using a Bayesian latent class model assuming an imperfect gold standard. Am J Trop Med Hyg. 2014 Jan;90(1):114-120. doi: 10.4269/ajtmh.13-0384. Epub 2013 Nov 11.

    PubMed 24218407

  • Baker S, Favorov M, Dougan G. Searching for the elusive typhoid diagnostic. BMC Infect Dis. 2010 Mar 5;10:45. doi: 10.1186/1471-2334-10-45.

    PubMed 20205702

  • Bhaskaran D, Chadha SS, Sarin S, Sen R, Arafah S, Dittrich S. Diagnostic tools used in the evaluation of acute febrile illness in South India: a scoping review. BMC Infect Dis. 2019 Nov 13;19(1):970. doi: 10.1186/s12879-019-4589-8.

    PubMed 31722678

  • Wijedoru L, Mallett S, Parry CM. Rapid diagnostic tests for typhoid and paratyphoid (enteric) fever. Cochrane Database Syst Rev. 2017 May 26;5(5):CD008892. doi: 10.1002/14651858.CD008892.pub2.

    PubMed 28545155

  • Mather RG, Hopkins H, Parry CM, Dittrich S. Redefining typhoid diagnosis: what would an improved test need to look like? BMJ Glob Health. 2019 Oct 31;4(5):e001831. doi: 10.1136/bmjgh-2019-001831. eCollection 2019.

    PubMed 31749999

  • Lim C, Wannapinij P, White L, Day NP, Cooper BS, Peacock SJ, Limmathurotsakul D. Using a web-based application to define the accuracy of diagnostic tests when the gold standard is imperfect. PLoS One. 2013 Nov 12;8(11):e79489. doi: 10.1371/journal.pone.0079489. eCollection 2013.

    PubMed 24265775

  • Lalremruata R, Chadha S, Bhalla P. Retrospective audit of the widal test for diagnosis of typhoid Fever in pediatric patients in an endemic region. J Clin Diagn Res. 2014 May;8(5):DC22-5. doi: 10.7860/JCDR/2014/7819.4373. Epub 2014 May 15.

    PubMed 24995178

  • Begg CB. Statistical methods in medical diagnosis. Crit Rev Med Inform. 1986;1(1):1-22.

    PubMed 3331577

  • Njuguna HN, Cosmas L, Williamson J, Nyachieo D, Olack B, Ochieng JB, Wamola N, Oundo JO, Feikin DR, Mintz ED, Breiman RF. Use of population-based surveillance to define the high incidence of shigellosis in an urban slum in Nairobi, Kenya. PLoS One. 2013;8(3):e58437. doi: 10.1371/journal.pone.0058437. Epub 2013 Mar 7.

    PubMed 23505506

  • Maude RR, de Jong HK, Wijedoru L, Fukushima M, Ghose A, Samad R, Hossain MA, Karim MR, Faiz MA, Parry CM; CMCH Typhoid Study Group. The diagnostic accuracy of three rapid diagnostic tests for typhoid fever at Chittagong Medical College Hospital, Chittagong, Bangladesh. Trop Med Int Health. 2015 Oct;20(10):1376-84. doi: 10.1111/tmi.12559. Epub 2015 Jul 15.

    PubMed 26094960

Questions about this trial

What is this clinical trial studying?

An observational study of Typhoid Fever, run by Kenya Medical Research Institute at 1 site in Kenya.

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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 Kenya. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Robert S Onsare, PhD (+254722337004, robert.s.onsare@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Point estimates of sensitivity and specificity for each test, with 95% confidence interval, using blood culture as reference standard. (time frame: At the end of the 6-month sampling period). 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 NCT04673487, which also lists 14 linked publications.

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 17 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in