Status:
COMPLETED
Evaluating Diagnostics for Paediatric Tuberculosis by Blood Culture
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
National Children's Hospital, Vietnam
Conditions:
Tuberculosis Infection
Eligibility:
All Genders
Up to 15 years
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...
Detailed Description
Tuberculosis (TB) is a major cause of morbidity and mortality among children in developing nations. Symptom-based diagnostic criteria are non-specific and culture confirmation is challenging, as sputu...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT01434758
Start Date
April 1 2011
End Date
September 1 2015
Last Update
November 15 2016
Active Locations (1)
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1
National Hospital of Pediatrics
Hanoi, Hanoi, Vietnam