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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Liverpool School of Tropical Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00456469
First received: April 4, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children

Resource links provided by NLM:


Further study details as provided by Liverpool School of Tropical Medicine:

Estimated Enrollment: 500
Study Start Date: May 2007
Estimated Study Completion Date: October 2009
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.

  Eligibility

Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456469

Contacts
Contact: Luis Cuevas, MD MTropMed 0151 705 3219 lcuevas@liv.ac.uk

Locations
Ethiopia
Bushullo Major Health Centre Not yet recruiting
Awassa, Southern Region, Ethiopia, 12
Contact: Mohammed Yassin, Dr         
Sub-Investigator: Mohammed Yassin, Dr         
Sponsors and Collaborators
Liverpool School of Tropical Medicine
Thrasher Research Fund
Investigators
Principal Investigator: Luis Cuevas, Dr Liverpool School of Tropical Medicine
  More Information

No publications provided by Liverpool School of Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00456469     History of Changes
Other Study ID Numbers: 06.49 TF Cuevas
Study First Received: April 4, 2007
Last Updated: April 4, 2007
Health Authority: Ethiopia: Ethiopia Science and Technology Commission
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Liverpool School of Tropical Medicine:
TB
latent
infection
Ethiopia

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 29, 2014