An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda

NCT01422798 | Completed

• 1 other identifier: Epicentre/MBA/2011/TBKidcohort
• Study Type: observational
• Target: 396
• Locations: 0 countries
• Sites: N/A

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 recommended TB drug dosages.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Number of confirmed, certain, probable and unlikely TB cases among TB suspects

  Week 48

Secondary Outcomes (11)

• Baseline clinical presentation of TB suspects

  Week 12 and 24

• Baseline biological characteristics (smear microscopy, culture and XpertMTB/RIF® of sputum and other specimen for EPTB suspects) of TB suspects

  Week 12 and 24

• XpertMTB/RIF® and culture results in stools of TB suspects

  Week 12 and 24

• Number of children started on TB treatment among TB suspects

  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

  Week 12

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Epicentre: lead
• Mbarara University of Science and Technology: collaborator
• Medecins Sans Frontieres, Netherlands: collaborator

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Margaret Nansumba, MD

  Epicentre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 24, 2011
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share