Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT01434758
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2011-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Diagnostics for Paediatric Tuberculosis by Blood Culture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000085343', 'term': 'Latent Infection'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* sputum\n* gastric aspirate\n* blood\n* urine\n* cerebrospinal fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-13', 'studyFirstSubmitDate': '2011-04-06', 'studyFirstSubmitQcDate': '2011-09-14', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield of TB culture', 'timeFrame': 'At baseline - day 1 of study', 'description': 'Number of positive TB cultures versus number of positive TB direct smears for expectorate and/or gastric aspirate.'}, {'measure': 'Diagnostic yield of TB culture', 'timeFrame': 'At baseline - day 1 of study', 'description': 'Number of positive TB cultures versus number of positive MODS cultures for expectorate and/or gastric aspirate.'}, {'measure': 'Diagnostic yield of urine versus expectorate or gastric aspirate for TB culture', 'timeFrame': 'At baseline - day 1 of study', 'description': 'Number of positive TB cultures in urine versus expectorate and/or gastric aspirate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mycobacterium tuberculosis', 'Culture yield'], 'conditions': ['Tuberculosis Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.oucru.org/index.php?option=com_content&view=article&id=336&mode=0&fil=&ox=&cd=09TB&type=&inv=&en=&vn=&ran=0.9122891888036086', 'label': 'OUCRU studies public site'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 sputum samples are often believed to be to too cumbersome to obtain from small children and specimens typically have low yield due to the paucibacillary nature of pediatric TB. Culture confirmation may be obtained in as few as 10% of cases of suspected pediatric TB. For these reasons, the true extent of the (drug-resistant) TB epidemic in children is unknown. Thus, either clinicians begin empiric treatment without diagnosis or no treatment is given at all. Current laboratory methods, if available at all in resource poor settings, employ smears from expectorated sputa or gastric aspirates which have low sensitivity in children. While more rapid diagnostic techniques such as PCR based tests have been developed, there is still poor sensitivity in children. Improving the diagnosis of pediatric TB must focus on better efforts, including more aggressive strategies to uncover disseminated disease.\n\nCulture confirmation of disseminated disease can be obtained from blood, urine, cerebrospinal fluid (CSF), peritoneal and pleural fluid, or purulent material from lymph node aspirates, abscesses or otorrhea. Unfortunately, little is known about the overall yield from these various specimens in children. From pilot data collected among children at NHP, we know that it is feasible to collect and test various bodily fluid specimens for TB culture.\n\nAlthough WHO guidelines encourage body fluid collection in order to make a diagnosis of TB in children, at present in NHP, blood and urine cultures are not obtained for mycobacterial culture. However, this study seeks to demonstrate that routine investigation of blood and urine will augment the yield of traditional sputum culture for children in whom disseminated disease is more likely. Improved culture confirmation will allow DST and a more accurate description of the drug-resistant TB epidemic for children in the region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population is children aged 0-15 years presenting to NHP thought to have TB infection according to inclusion criteria listed in this protocol.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 0-15, presenting at NHP;\n* Unexplained fever for more than 2 weeks; and\n* Any form of TB suspected based on at least two of the following findings:\n\n * unexplained cough for more than 2 weeks\n * radiographic findings suggestive of tuberculosis.\n * failure to thrive/weight loss\n * enlarged non-tender lymph nodes or lymph node abscess, especially of the neck\n * signs of meningitis with prodromal stage of at least one week\n * HIV positive\n * malnourished\n * TB contact history\n * Clinical judgment treating doctor.\n* Relevant material (sputum or gastric aspirate, blood, and urine) available for microbiological diagnosis.\n* Informed consent obtained from the patient's legal guardian(s).\n\nExclusion Criteria:\n\n* Age \\>15 years\n* Diagnosed or treated for TB in the past year, received drugs effective against TB in last 3 months.\n* Clinical contra-indications to collect the required study specimens"}, 'identificationModule': {'nctId': 'NCT01434758', 'briefTitle': 'Evaluating Diagnostics for Paediatric Tuberculosis by Blood Culture', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Clinical Research Unit, Vietnam'}, 'officialTitle': 'Evaluating Diagnostics for Paediatric Tuberculosis by Blood Culture', 'orgStudyIdInfo': {'id': '09TB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children', 'description': 'Children age 0-15 years presenting to NHP thought to have TB infection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'state': 'Hanoi', 'country': 'Vietnam', 'facility': 'National Hospital of Pediatrics', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Heiman F Wertheim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Clinical Research Unit - Hanoi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Clinical Research Unit, Vietnam', 'class': 'OTHER'}, 'collaborators': [{'name': "National Children's Hospital, Vietnam", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}