An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda|
- Number of confirmed, certain, probable and unlikely TB cases among TB suspects [ Time Frame: Week 48 ]
- Baseline clinical presentation of TB suspects [ Time Frame: Week 12 and 24 ]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
- 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 ]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
- 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 ]
|Study Start Date:||April 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422798
|Principal Investigator:||Margaret Nansumba, MD||Epicentre|