Tuberculosis Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 396 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 14 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Mbarara University of Science and Technology, Medecins Sans Frontieres |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of confirmed, certain, probable and unlikely TB cases among TB suspects | Week 48 | No | |
Secondary | 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 | Week 12 and 24 | No |
Secondary | 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 | Week 12 and 24 | No |
Secondary | XpertMTB/RIF® and culture results in stools of TB suspects | Week 12 and 24 | No | |
Secondary | Number of children started on TB treatment among TB suspects | Week 24 | No | |
Secondary | 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 | Week 12 | No | |
Secondary | Treatment successes (cured and completed), failures, defaulters and deaths | Week 48 | No | |
Secondary | TB recurrence 6 months after completion of TB treatment | Week 48 | No | |
Secondary | Antiretroviral treatment (ART) regimen and time to initiation in co-infected children | Week 48 | No | |
Secondary | Occurrence and clinical description of IRIS episodes | Within 2 months of ART initiation | No | |
Secondary | Type and frequency of grade 3 and 4 adverse events during TB treatment, with/without concomitant ART | Week 2, 4, 8, 16, 24 | No | |
Secondary | Pill burden, adherence rate and drugs errors with the use of new paediatric dosages | Week 2, 4, 6, 8, 12, 16, 20, 24 | No |
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