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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Epicentre
Sponsor:
Collaborators:
Mbarara University of Science and Technology
Medecins Sans Frontieres
Information provided by (Responsible Party):
Epicentre
ClinicalTrials.gov Identifier:
NCT01492595
First received: December 8, 2011
Last updated: February 16, 2013
Last verified: February 2013
  Purpose

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.


Condition
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of Children in Household Contact With Adult TB Patients in Mbarara Hospital, Uganda: An Open Cohort of Children <5 Years in Contact With Newly Diagnosed Adult TB Cases in Mbarara Hospital

Resource links provided by NLM:


Further study details as provided by Epicentre:

Primary Outcome Measures:
  • Proportion of <5 year-old child contacts classified as active TB disease, LTBI or no infection [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of children <5 years exposed to TB in the household of adult index cases [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of contacts identified as active TB basing on a symptom-based approach compared with those based on chest radiography [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Proportion of contacts with HIV co-infection classified as non infected, LTBI or active TB [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Median duration of exposure to symptomatic source case among the contacts in the various classes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Association of various risk factors with the final classification of contacts after assessment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Proportion of children with LTBI successfully treated (prevented from developing active TB disease) among HIV-infected and uninfected children [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Proportion of children with no TB infection or disease successfully treated (prevented from developing active TB disease or LTBI) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Proportion of adverse events on treatment of TB disease, LTBI and TB exposure [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Adherence to IPT regimens [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month to 5 Years
Genders Eligible for Study:   Both
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

Criteria

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:

  • Child currently receiving anti-tuberculosis treatment
  • Child has received a full course of anti-TB treatment within the last 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492595

Contacts
Contact: juliet Mwanga-Amumpaire, MMED Pediatrics juliet.mwanga@epicentre.msf.org

Locations
Uganda
Mbarara National Referral Hospital Recruiting
Mbarara, Uganda
Contact: Juliet Mwanga-Amumpaire, MMED Pediatrics    256793328748    juliet.mwanga@epicentre.msf.org   
Sponsors and Collaborators
Epicentre
Mbarara University of Science and Technology
Medecins Sans Frontieres
Investigators
Principal Investigator: Julius Kiwanuka, MD Mbarara University of Science and Technology
  More Information

No publications provided

Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT01492595     History of Changes
Other Study ID Numbers: Epicentre/MBA/2011/TBcontact
Study First Received: December 8, 2011
Last Updated: February 16, 2013
Health Authority: France: Committee for the Protection of Personnes
Uganda: National Council for Science and Technology

Keywords provided by Epicentre:
contact

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on October 23, 2014