Status:
COMPLETED
An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
Lead Sponsor:
Epicentre
Collaborating Sponsors:
Mbarara University of Science and Technology
Medecins Sans Frontieres, Netherlands
Conditions:
Tuberculosis
Eligibility:
All Genders
1-14 years
Brief 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 rec...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT01422798
Start Date
April 1 2012
End Date
December 1 2014
Last Update
March 2 2016
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