Tuberculosis InfectionNCT01434758
Evaluating Diagnostics for Paediatric Tuberculosis by Blood Culture
An observational study of Tuberculosis Infection, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Tuberculosis Infection
- How many people
- 560 participants
- Where
- 1 siteVietnam
- Study dates
- Apr 2011to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
Culture 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.
Although 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.
- Conditions
- Tuberculosis Infection
- Keywords
- Mycobacterium tuberculosis, Culture yield
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Children age 0-15 years presenting to NHP thought to have TB infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of TB culture
Number of positive TB cultures versus number of positive TB direct smears for expectorate and/or gastric aspirate.
Measured: 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.
Measured: 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.
Measured: At baseline - day 1 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- National Children's Hospital, Vietnam
- Responsible party
- Sponsor
- Investigators
- Heiman F Wertheim, PhD, Principal investigator, Oxford University Clinical Research Unit - Hanoi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434758
- Sponsor's protocol ID
- 09TB
- Status last verified
- Nov 2013
- First submitted
- 6 Apr 2011
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Diagnostics for Paediatric Tuberculosis by Blood Culture
- ClinicalTrials.gov ID
- NCT01434758
- Acronym / sponsor ID
- 09TB
- Conditions
- Tuberculosis Infection
- Keywords
- Mycobacterium tuberculosis, Culture yield
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- National Children's Hospital, Vietnam
- Study start
- Apr 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Culture 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.
Although 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Children age 0-15 years presenting to NHP thought to have TB infection |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (14 listed)
- 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:
- Relevant material (sputum or gastric aspirate, blood, and urine) available for microbiological diagnosis.
- Informed consent obtained from the patient's legal guardian(s).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic yield of TB culture
Time frame: At baseline - day 1 of study
Number of positive TB cultures versus number of positive TB direct smears for expectorate and/or gastric aspirate.
Diagnostic yield of TB culture
Time frame: At baseline - day 1 of study
Number of positive TB cultures versus number of positive MODS cultures for expectorate and/or gastric aspirate.
Diagnostic yield of urine versus expectorate or gastric aspirate for TB culture
Time frame: At baseline - day 1 of study
Number of positive TB cultures in urine versus expectorate and/or gastric aspirate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- OUCRU studies public siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiman F Wertheim, PhD principal investigator
Oxford University Clinical Research Unit - Hanoi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis Infection, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of TB culture (time frame: At baseline - day 1 of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.