Screening of Children in Household Contact With Adult TB Patients in Mbarara Hospital, Uganda

NCT01492595 | Completed

• 1 other identifier: Epicentre/MBA/2011/TBcontact
• Study Type: observational
• Target: 281
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed study aims to establish a pilot program through a prospective cohort study offering routine contact tracing, investigation and prophylaxis for LTBI, and treatment of TB disease to children \<5 years living in the same household as adults diagnosed with smear/culture-positive pulmonary TB in Mbarara Regional Referral Hospital

Conditions

Tuberculosis

Keywords

contact

Outcome Measures

Primary Outcomes (1)

• Proportion of <5 year-old child contacts classified as active TB disease, LTBI or no infection

  Baseline

Secondary Outcomes (9)

• Number of children <5 years exposed to TB in the household of adult index cases

  Baseline

• Number of contacts identified as active TB basing on a symptom-based approach compared with those based on chest radiography

  9 months

• Proportion of contacts with HIV co-infection classified as non infected, LTBI or active TB

  9 months

• Median duration of exposure to symptomatic source case among the contacts in the various classes

  Baseline

• Association of various risk factors with the final classification of contacts after assessment

  9 months

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1 month to 5 years living in the same household (a house or cluster of houses on the same plot) with a newly diagnosed adult case of smear and/or culture-positive TB will be eligible for the study

You may qualify if:

• Any child who has lived in the same household with the index case continuously for at least 2 weeks within the 3-month period immediately preceding the diagnosis of smear- positive or culture-positive TB in the index case.
• Informed consent signed by the parent or legal guardian
• Living within a 2-hour radius of Mbarara town

You may not qualify if:

• Child currently receiving anti-tuberculosis treatment
• Child has received a full course of anti-TB treatment within the last 6 months

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

• Julius Kiwanuka, MD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 15, 2011
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share