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Status unknownNCT00456469ALTACUpdated Apr 5, 2007

Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children

An observational study in Tuberculosis, sponsored by Liverpool School of Tropical Medicine. Status unknown at 1 site in Ethiopia. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2007-04-05.

Sponsored by Liverpool School of Tropical Medicine · Observational

The sponsor has not verified this record recently (last verified Apr 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Defined population
Time perspective
Prospective
Enrollment
500
Ages
1 Year to 14 Years
Sex
All
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Study summary

Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with TB have positive acute reactants such as IFN-y and other cytokine responses; if these responses discriminate between high and low risk of disease progression and whether these could be incorporated into improved diagnostic approaches.

Read the detailed description

The study follows children in contact with TB. Those with positive TST will be offered chemoprophylaxis and all children will be followed for 2 years to describe IFN-y responses over time, identify symptoms of active TB and if these symptoms are associated with IFN-y and other cytokine responses.

Children with suspicion of TB attending health centres will also be investigated using routine diagnostic tests and IFN-y and other cytokines responses to evaluate if the latter could be used in improved diagnostic approaches.

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Conditions studied

  • Tuberculosis

Keywords

  • TB
  • latent
  • infection
  • Ethiopia
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 500 is above the median of 240 across 2,136 observational studies indexed under Infections.

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Lead sponsor

Liverpool School of Tropical Medicine is the lead sponsor of 57 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children - 1 to 14 years old in contact with adults with smear positive TB

Or:

  • Children with suspicion of TB admitted to the hospital for investigations

Exclusion criteria

Exclusion Criteria:

  • Residency > 10 Km from recruitment center

Or:

  • Patient severely to undergo diagnostic procedures.
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Study design

Observational model
Defined population
Time perspective
Prospective
Enrollment
500 participants
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Study locations

1 site
  • Bushullo Major Health Centre
    Awassa, Southern Region 12, Ethiopia
    • Mohammed Yassin, Dr · Contact
    • Mohammed Yassin, Dr · Sub investigator
07

References and documents

Publications

  • Yassin MA, Petrucci R, Garie KT, Harper G, Teshome A, Arbide I, Asnake G, Ahmed HJ, Mammo T, Yesuf K, Cuevas LE. Use of tuberculin skin test, IFN-gamma release assays and IFN-gamma-induced protein-10 to identify children with TB infection. Eur Respir J. 2013 Mar;41(3):644-8. doi: 10.1183/09031936.00012212. Epub 2012 Sep 20. PubMed 22997219 ↗
  • Garie KT, Yassin MA, Cuevas LE. Lack of adherence to isoniazid chemoprophylaxis in children in contact with adults with tuberculosis in Southern Ethiopia. PLoS One. 2011;6(11):e26452. doi: 10.1371/journal.pone.0026452. Epub 2011 Nov 1. PubMed 22069451 ↗
  • Yassin MA, Petrucci R, Garie KT, Harper G, Arbide I, Aschalew M, Merid Y, Kebede Z, Bawazir AA, Abuamer NM, Cuevas LE. Can interferon-gamma or interferon-gamma-induced-protein-10 differentiate tuberculosis infection and disease in children of high endemic areas? PLoS One. 2011;6(9):e23733. doi: 10.1371/journal.pone.0023733. Epub 2011 Sep 23. PubMed 21966356 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00456469
Lead sponsor
Liverpool School of Tropical Medicine
Collaborators
Thrasher Research Fund
First posted
Apr 5, 2007
Start date
May 2007
Completion
Oct 2009 (estimated)
Last update
Apr 5, 2007

Study contacts

Luis Cuevas, MD MTropMed
Contact
lcuevas@liv.ac.uk
0151 705 3219
Luis Cuevas, Dr
principal investigator · Liverpool School of Tropical Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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