NCT04673487

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

December 1, 2020

Last Update Submit

December 12, 2020

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (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.

    At the end of the 6-month sampling period

Secondary Outcomes (2)

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

    At the end of the 6-month sampling period

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

    At the end of the 6-month sampling period

Interventions

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

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

Also known as: 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.

Eligibility Criteria

Age8 Years - 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenya Medical Research Institute

Nairobi, 254, Kenya

Location

Related Publications (14)

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

    PMID: 30767000RESULT

  • 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.

    PMID: 31967084RESULT

  • 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.

    PMID: 28515903RESULT

  • 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.

    PMID: 25778504RESULT

  • 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.

    PMID: 24218407RESULT

  • 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.

    PMID: 20205702RESULT

  • 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.

    PMID: 31722678RESULT

  • 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.

    PMID: 28545155RESULT

  • 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.

    PMID: 31749999RESULT

  • 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.

    PMID: 24265775RESULT

  • 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.

    PMID: 24995178RESULT

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

    PMID: 3331577RESULT

  • 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.

    PMID: 23505506RESULT

  • 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.

    PMID: 26094960RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples obtained from whole blood samples

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Robert S Onsare, PhD

CONTACT

+254722337004robert.s.onsare@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 17, 2020

Study Start

January 1, 2021

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

KE(1)