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CompletedNCT01492595TBcontactUpdated Mar 2, 2016

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

An observational study in Tuberculosis, sponsored by Epicentre. Completed. Open to participants aged 1 Month to 5 Years. Per ClinicalTrials.gov, last updated 2016-03-02.

Sponsored by Epicentre · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
281
Ages
1 Month to 5 Years
Sex
All
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Study 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

Read the detailed description

Because children with tuberculosis (TB) are usually smear-negative and therefore less infectious, they are generally not considered a public health risk. Up to 70% of children living in the same household with an adult with infectious TB will become infected, and more than 20% of them will develop active TB disease, usually within 12 months. The individual risk of developing disease once infected is highest in children \<5 years. In addition, children under 5 years are at higher risk of developing disseminated forms of TB. The impact of childhood TB is worsened by co-infection with HIV. Contact tracing, investigation and prophylaxis of childhood contacts of adult TB cases are widely recommended but rarely practiced in developing countries. The World Health Organization recommends that all NTPs screen household contacts for symptoms of disease and offer isoniazid preventive therapy (i.e. daily isoniazid for at least 6 months) to children aged less than 5 years and to all HIV-infected children who are household contacts. In Mbarara, an area with a high incidence of TB, no program currently exists for the routine investigation of child contacts of adult pulmonary TB cases. Almost all child TB cases registered are found through the evaluation of symptomatic children, often long after the adult source-cases have been investigated and treated. The number of adult cases with pulmonary TB, together with the population structure in Mbarara (>50% of the total population being children) suggests that the number of childhood TB cases is probably higher than current hospital records indicate.

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. The study will also generate much needed data on the utility of simple symptom-based screening of child contacts for TB disease in areas where access to radiological examination and tuberculin skin test are limited and on the efficacy and safety of IPT, in a region with a significant problem of HIV co-infection.

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. Children will undergo a physical examination, chest Xray, tuberculin skin test and specimen collection in case of symptoms. Children will then be classified as active TB, TB infected and non infected cases. TB infected and non infected children will receive 6 months isoniazid prophylaxis with monthly monitoring of acceptability and tolerability. A final clinical assessment will be performed at 9 months. A total of 577 children contacts will be enrolled.

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Conditions studied

  • Tuberculosis

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Keywords

  • contact
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 281 is above the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Epicentre is the lead sponsor of 47 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
281 participants (actual)
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What researchers measure

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

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

    Time frame: Baseline

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

    Time frame: 9 months

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

    Time frame: 9 months

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

    Time frame: Baseline

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

    Time frame: 9 months

  6. Proportion of children with LTBI successfully treated (prevented from developing active TB disease) among HIV-infected and uninfected children

    Time frame: 9 months

  7. Proportion of children with no TB infection or disease successfully treated (prevented from developing active TB disease or LTBI)

    Time frame: 9 months

  8. Proportion of adverse events on treatment of TB disease, LTBI and TB exposure

    Time frame: 9 months

  9. Adherence to IPT regimens

    Time frame: 9 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01492595
Lead sponsor
Epicentre
Collaborators
Mbarara University of Science and Technology, Medecins Sans Frontieres, Netherlands
Responsible party
Sponsor
First posted
Dec 15, 2011
Start date
Apr 2012
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Mar 2, 2016

Study contacts

Julius Kiwanuka, MD
principal investigator · Mbarara University of Science and Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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