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

NCT ID: NCT00456469

Last Updated: 2007-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tuberculosis

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

\- Residency \> 10 Km from recruitment center

Or:

\- Patient severely to undergo diagnostic procedures.
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thrasher Research Fund

OTHER

Sponsor Role collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Luis Cuevas, Dr

Role: PRINCIPAL_INVESTIGATOR

Liverpool School of Tropical Medicine

Locations

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Bushullo Major Health Centre

Awasa, Southern Region, Ethiopia

Site Status

Countries

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Ethiopia

Central Contacts

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Luis Cuevas, MD MTropMed

Role: CONTACT

[email protected]
0151 705 3219

Facility Contacts

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Mohammed Yassin, Dr

Role: primary

References

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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.

Reference Type DERIVED
PMID: 22997219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22069451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21966356 (View on PubMed)

Other Identifiers

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06.49 TF Cuevas

Identifier Type: -

Identifier Source: org_study_id