A new direction for tuberculosis control in highly endemic countries: a randomised controlled trial of active case finding

Not Applicable

Completed

• Conditions: tuberculosis; Infection - Studies of infection and infectious agents; Public Health - Epidemiology; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12610000600044
• Lead Sponsor: ational Health and Medical Research Council, Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19600

Inclusion Criteria

Inclusion for index patients:
- smear positive (stain positive for acid fast bacilli on at least one sputum smear)
- aged 15 years or older

Inclusion for household contacts
- members of the household of index patients during the previous 2 months (including contact with the index patient for a minimum of 8 hours in total)
- no age limit

Exclusion Criteria

Exclusion for index patients:
- primary residence outside of the geographical region of the study (due to difficulty with follow-up)
- index patient has no household contacts
- severe difficulty with communication

Exclusion for household contacts:
- not living in same household as the index patient
- already taking treatment for tuberculosis at the time of recruitment
- unwilling to participate in follow-up over 2 years of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the case detection rate of tuberculosis among household contacts during the two year follow-up period of the trial. This is measured by clinical diagnosis (according to World Health Organization definition of active tuberculosis). A diagnosis of tuberculosis can be reached based upon clinical history and examination, chest Xray and microbiological diagnosis (sputum investigation including culture). Tuberculosis will be classified as either smear positive, smear negative or all tuberculosis. The diagnosis of tuberculosis in contacts will be classified as pulmonary tuberculosis or extra-pulmonary tuberculosis.[2 years from enrollment of the contacts.]

Secondary Outcome Measures

Name	Time	Method
Rate of pulmonary tuberculosis[2 years following enrollment.];Rate of culture positive tuberculosis[2 years following enrollment];Rate of smear positive tuberculosis[2 years after enrollment.];Health system costs using a cost analysis based upon questionnaires and health care costs records of participants[2 years after enrollment];Health care costs of contacts who develop tuberculosis during the study period, using a cost analysis based upon questionnaires and health care costs records of participants[2 years following recruitment];Deaths among contacts, based upon reported deaths and medical records[2 years following recruitment]