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Evaluating Diagnostics for Paediatric Tuberculosis by Blood Culture

NCT01434758 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 560

Last updated 2016-11-15

No results posted yet for this study

Summary

Detection of M. tuberculosis in clinical specimens of children has a low sensitivity because specimens are either difficult to collect or contain low levels of M. tuberculosis. Diagnostic criteria are non-specific and culture confirmation is challenging, as sputum samples are not often obtainable from small children and specimens typically have low yield. Although children are typically thought to have paucibacillary disease, they are at greater risk for dissemination of TB. This may allow for detection of Mycobacterium tuberculosis from other bodily fluids than sputum or gastric aspirate, including blood and urine. Unfortunately, little is known about the overall yield from these various specimens. From pilot data collected among adults and children in Tugela Ferry, we know that it is feasible to collect and test various bodily fluid specimens for TB culture. This study aim to test the hypothesis that blood and urine cultures will detect Mycobacterium tuberculosis from children suspected of disseminated TB, and that a proportion of these non-sputum bodily fluids will detect both drug-susceptible and drug-resistant tuberculosis when sputum or gastric culture does not.

Conditions

  • Tuberculosis Infection

Sponsors & Collaborators

  • National Children's Hospital, Vietnam

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Heiman F Wertheim, PhD · Oxford University Clinical Research Unit - Hanoi

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-12-31
Completion
2015-09-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01434758 on ClinicalTrials.gov