TuberculosisNCT01422798
An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
An observational study of Tuberculosis, run by Epicentre.
Trial summary
The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Tuberculosis
- How many people
- 396 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 2014
- 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 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged one month to 14 years and identified as TB suspect will be eligible to the study. Definition of TB suspect was adapted from the definitions proposed by WHO guidelines (World Health Organisation 2006).
Who may be able to join
- Any child with at least one of the following criteria:
- Unexplained weight loss or documented failure to thrive or stagnant weight or Growth faltering on the growth charts over the past 3 months despite adequate nutrition and deworming,
- Non - remittent cough or wheeze for more than 2 weeks,
- Night sweats persistent or intermittent during the last 2 weeks
- Prolonged fever (temperature > 38°C) for 7 days, after common causes such malaria or pneumonia has been excluded.
- Wheeze/Stridor - persistent, non remitting during the last 2 weeks
Show all 15Show fewer
- Chest pain - Persistent, localized, pleuritic in nature during the last 2 weeks
- Unexplained fatigue, weakness, apathy, lethargy or reduced playfulness during the last 2 weeks
- Painless superficial lymph node mass (>2x2cm)-
- Chronic onset meningitis (>5days), lymphocytic predominance in CSF or meningitis not responding to antibiotic treatment (ref 8)
- Recent gibbus
- Abdominal distention with ascites OR
- Any child with an abnormal chest X-ray (CXR) suggestive of TB (hilar/paratracheal adenopathy with/without airway compression, airspace opacification not responding to antibiotics or documented TB contact, lung cavities or miliary infiltrates) OR
- Asymptomatic child with a history of recent contact (within past year) with a pulmonary TB smear or culture positive patient and an abnormal chest X-ray AND
- Informed Consent signed by parent or legal representative
Who cannot join
- Current TB treatment (patient who received < 3 days of treatment or patients receiving IPT could be still included) or TB treatment completed within the past 6 months.
- Absence of informed consent
- Living outside of Greater Mbarara region.
- Unable or unwilling to attend to the follow-up visits
About this study
The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.
Read the detailed description
Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide. The situation for children in this epidemic is complex because they are usually considered less infectious and therefore, not to represent an important public health problem. Uganda ranks among the countries with the highest TB burden with 330/100,000 person-year TB incidence. Up to 16% of new TB infections are estimated to occur in children. Diagnosis of childhood TB is usually based on exposure history and a set of clinical, radiological and biological signs that considered separately have rather low predictive values. There is no consensus on the optimal way to combine these signs. This is even more complex when the child is infected with HIV. The risk of TB infection and disease, and the TB clinical presentation depend on the child's age, the youngest being at highest risk. An important first step in improving the management of childhood TB is to better define the clinical and radiological characteristics of children with suspected TB at first presentation to a health service in an endemic setting; also to document the feasibility and tolerability of TB treatment in this age cohort. This initial descriptive study would help to pave the way for more rigorous studies evaluating novel diagnostics and conducting clinical trials on first and second line TB treatment in children, in the future.
The main objective of the study is to improve the diagnosis of TB in children in a setting of high TB and HIV prevalence and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.
The investigators will conduct an observational cohort study of paediatric TB suspects attending the Mbarara National Reference Hospital (MNRH). All included TB suspects will have an initial comprehensive assessment including clinical examination, chest X-ray, tuberculin skin test, smear microscopy, Mycobacterium tuberculosis culture, XpertMTB/RIF® of respiratory or extra-pulmonary specimen for diagnosis of tuberculosis. For children who cannot produce sputum, sputum induction will be proposed. Children with indication of TB treatment will be followed up to 6 months after completion of TB treatment (total 12 months) with treatment efficiency, tolerability and acceptability assessment. Children without indication of TB treatment will undergo a systematic clinical assessment after 3 months. Finally, clinical files from all TB suspects will be retrospectively reviewed by 2 independent paediatric TB experts in order to classify the cases as Confirmed TB, Certain TB, Probable TB and Unlikely TB cases. A total of 385 paediatric TB suspects (1 month-14 years) will be screened from the paediatric ward, OPD, HIV clinic of the MNRH, Holy Innocents children's hospital and The AIDS support organisation (TASO) in Mbarara.
- Conditions
- Tuberculosis
- Medical subject headings
- Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of confirmed, certain, probable and unlikely TB cases among TB suspects
Measured: Week 48
Secondary outcomes (11)
Baseline clinical presentation of TB suspects
Baseline clinical presentation of TB suspects: overall, among sub-groups of children defined by HIV infection, malnutrition, age category (<3 years, 3-10 years and > 10 years), TB treatment decision and according to the TB classification using the proxy reference standard
Measured: Week 12 and 24
Baseline biological characteristics (smear microscopy, culture and XpertMTB/RIF® of sputum and other specimen for EPTB suspects) of TB suspects
Baseline biological characteristics (smear microscopy, culture and XpertMTB/RIF® of sputum and other specimen for EPTB suspects) of TB suspects: overall, among sub-groups of children defined by HIV infection, age category (<3 years, 3-10 years and > 10 years), TB treatment decision and disease classification
Measured: Week 12 and 24
XpertMTB/RIF® and culture results in stools of TB suspects
Measured: Week 12 and 24
Number of children started on TB treatment among TB suspects
Measured: Week 24
Number of TB suspect cases who were initially diagnosed as non TB who died or eventually received a TB diagnosis within the first 3 months of clinical follow-up
Measured: Week 12
Treatment successes (cured and completed), failures, defaulters and deaths
Measured: Week 48
TB recurrence 6 months after completion of TB treatment
Measured: Week 48
Antiretroviral treatment (ART) regimen and time to initiation in co-infected children
Measured: Week 48
Occurrence and clinical description of IRIS episodes
Measured: Within 2 months of ART initiation
Type and frequency of grade 3 and 4 adverse events during TB treatment, with/without concomitant ART
Measured: Week 2, 4, 8, 16, 24
Pill burden, adherence rate and drugs errors with the use of new paediatric dosages
Measured: Week 2, 4, 6, 8, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Medecins Sans Frontieres, Netherlands
- Responsible party
- Sponsor
- Investigators
- Margaret Nansumba, MD, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422798
- Sponsor's protocol ID
- Epicentre/MBA/2011/TBKidcohort
- Status last verified
- Feb 2016
- First submitted
- 15 Aug 2011
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
- ClinicalTrials.gov ID
- NCT01422798
- Acronym / sponsor ID
- Epicentre/MBA/2011/TBKidcohort
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Medecins Sans Frontieres, Netherlands
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Aug 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.
The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.
Detailed description
Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide. The situation for children in this epidemic is complex because they are usually considered less infectious and therefore, not to represent an important public health problem. Uganda ranks among the countries with the highest TB burden with 330/100,000 person-year TB incidence. Up to 16% of new TB infections are estimated to occur in children. Diagnosis of childhood TB is usually based on exposure history and a set of clinical, radiological and biological signs that considered separately have rather low predictive values. There is no consensus on the optimal way to combine these signs. This is even more complex when the child is infected with HIV. The risk of TB infection and disease, and the TB clinical presentation depend on the child's age, the youngest being at highest risk. An important first step in improving the management of childhood TB is to better define the clinical and radiological characteristics of children with suspected TB at first presentation to a health service in an endemic setting; also to document the feasibility and tolerability of TB treatment in this age cohort. This initial descriptive study would help to pave the way for more rigorous studies evaluating novel diagnostics and conducting clinical trials on first and second line TB treatment in children, in the future.
The main objective of the study is to improve the diagnosis of TB in children in a setting of high TB and HIV prevalence and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.
The investigators will conduct an observational cohort study of paediatric TB suspects attending the Mbarara National Reference Hospital (MNRH). All included TB suspects will have an initial comprehensive assessment including clinical examination, chest X-ray, tuberculin skin test, smear microscopy, Mycobacterium tuberculosis culture, XpertMTB/RIF® of respiratory or extra-pulmonary specimen for diagnosis of tuberculosis. For children who cannot produce sputum, sputum induction will be proposed. Children with indication of TB treatment will be followed up to 6 months after completion of TB treatment (total 12 months) with treatment efficiency, tolerability and acceptability assessment. Children without indication of TB treatment will undergo a systematic clinical assessment after 3 months. Finally, clinical files from all TB suspects will be retrospectively reviewed by 2 independent paediatric TB experts in order to classify the cases as Confirmed TB, Certain TB, Probable TB and Unlikely TB cases. A total of 385 paediatric TB suspects (1 month-14 years) will be screened from the paediatric ward, OPD, HIV clinic of the MNRH, Holy Innocents children's hospital and The AIDS support organisation (TASO) in Mbarara.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged one month to 14 years and identified as TB suspect will be eligible to the study. Definition of TB suspect was adapted from the definitions proposed by WHO guidelines (World Health Organisation 2006).
Key inclusion criteria (15 listed)
- Unexplained weight loss or documented failure to thrive or stagnant weight or Growth faltering on the growth charts over the past 3 months despite adequate nutrition and deworming,
- Non - remittent cough or wheeze for more than 2 weeks,
- Night sweats persistent or intermittent during the last 2 weeks
- Prolonged fever (temperature > 38°C) for 7 days, after common causes such malaria or pneumonia has been excluded.
- Wheeze/Stridor - persistent, non remitting during the last 2 weeks
Key exclusion criteria (4 listed)
- Current TB treatment (patient who received < 3 days of treatment or patients receiving IPT could be still included) or TB treatment completed within the past 6 months.
- Absence of informed consent
- Living outside of Greater Mbarara region.
- Unable or unwilling to attend to the follow-up visits
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
Number of confirmed, certain, probable and unlikely TB cases among TB suspects
Time frame: Week 48
11 secondary outcomes
Baseline clinical presentation of TB suspects
Time frame: Week 12 and 24
Baseline biological characteristics (smear microscopy, culture and XpertMTB/RIF® of sputum and other specimen for EPTB suspects) of TB suspects
Time frame: Week 12 and 24
XpertMTB/RIF® and culture results in stools of TB suspects
Time frame: Week 12 and 24
Number of children started on TB treatment among TB suspects
Time frame: Week 24
Number of TB suspect cases who were initially diagnosed as non TB who died or eventually received a TB diagnosis within the first 3 months of clinical follow-up
Time frame: Week 12
Treatment successes (cured and completed), failures, defaulters and deaths
Time frame: Week 48
TB recurrence 6 months after completion of TB treatment
Time frame: Week 48
Antiretroviral treatment (ART) regimen and time to initiation in co-infected children
Time frame: Week 48
Occurrence and clinical description of IRIS episodes
Time frame: Within 2 months of ART initiation
Type and frequency of grade 3 and 4 adverse events during TB treatment, with/without concomitant ART
Time frame: Week 2, 4, 8, 16, 24
Pill burden, adherence rate and drugs errors with the use of new paediatric dosages
Time frame: Week 2, 4, 6, 8, 12, 16, 20, 24
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 2 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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.
Margaret Nansumba, MD principal investigator
Epicentre
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Epicentre.
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 15 inclusion and 4 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 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of confirmed, certain, probable and unlikely TB cases among TB suspects (time frame: Week 48). 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 2 Mar 2016.