NCT00456469

Brief 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.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Typical duration 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

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

April 4, 2007

Last Update Submit

April 4, 2007

Conditions

Tuberculosis

Keywords

TBlatentinfectionEthiopia

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Residency \> 10 Km from recruitment center
  • Or:
  • \- Patient severely to undergo diagnostic procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bushullo Major Health Centre

Awasa, Southern Region, 12, Ethiopia

Location

Related Publications (3)

  • 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.

    PMID: 22997219DERIVED

  • 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.

    PMID: 22069451DERIVED

  • 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.

    PMID: 21966356DERIVED

MeSH Terms

Conditions

TuberculosisInfections

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Luis Cuevas, Dr

    Liverpool School of Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Cuevas, MD MTropMed

CONTACT

0151 705 3219lcuevas@liv.ac.uk

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

May 1, 2007

Study Completion

October 1, 2009

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations

ET(1)