An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

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.
    

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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
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).