Evaluating Diagnostics for Paediatric Tuberculosis by Blood Culture

NCT01434758 | Completed

• 1 other identifier: 09TB
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mycobacterium tuberculosis; Culture yield

Outcome Measures

Primary Outcomes (3)

• Diagnostic yield of TB culture

  Number of positive TB cultures versus number of positive TB direct smears for expectorate and/or gastric aspirate.

  At baseline - day 1 of study

• Diagnostic yield of TB culture

  Number of positive TB cultures versus number of positive MODS cultures for expectorate and/or gastric aspirate.

  At baseline - day 1 of study

• Diagnostic yield of urine versus expectorate or gastric aspirate for TB culture

  Number of positive TB cultures in urine versus expectorate and/or gastric aspirate.

  At baseline - day 1 of study

Study Arms (1)

Children

Children age 0-15 years presenting to NHP thought to have TB infection

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study population is children aged 0-15 years presenting to NHP thought to have TB infection according to inclusion criteria listed in this protocol.

You may qualify if:

• Aged 0-15, presenting at NHP;
• Unexplained fever for more than 2 weeks; and
• Any form of TB suspected based on at least two of the following findings:
• unexplained cough for more than 2 weeks
• radiographic findings suggestive of tuberculosis.
• failure to thrive/weight loss
• enlarged non-tender lymph nodes or lymph node abscess, especially of the neck
• signs of meningitis with prodromal stage of at least one week
• HIV positive
• malnourished
• TB contact history
• Clinical judgment treating doctor.
• Relevant material (sputum or gastric aspirate, blood, and urine) available for microbiological diagnosis.
• Informed consent obtained from the patient's legal guardian(s).

You may not qualify if:

• Age \>15 years
• Diagnosed or treated for TB in the past year, received drugs effective against TB in last 3 months.
• Clinical contra-indications to collect the required study specimens

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• National Children's Hospital, Vietnam: collaborator

Study Sites (1)

National Hospital of Pediatrics

Hanoi, Hanoi, Vietnam

Location

Related Links

• OUCRU studies public site

Biospecimen

Retention: SAMPLES WITH DNA

* sputum * gastric aspirate * blood * urine * cerebrospinal fluid

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Heiman F Wertheim, PhD

  Oxford University Clinical Research Unit - Hanoi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: September 15, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: September 1, 2015
• Last Updated: November 15, 2016

Record last verified: 2013-11

Locations

VN (1)