An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
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.
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.
Inclusion Criteria:

 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

 -  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

 Exclusion Criteria:

 -  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