Start Taking Action For TB Diagnosis

Launched by LIVERPOOL SCHOOL OF TROPICAL MEDICINE · Apr 25, 2023

Keywords

ClinConnect Summary

The "Start Taking Action For TB Diagnosis" clinical trial is focused on improving how tuberculosis (TB) is diagnosed, especially in primary health care settings. TB is a serious infectious disease that claims millions of lives each year, and many people remain undiagnosed due to ineffective testing methods. This study aims to find better diagnostic tools and combinations of tests that can quickly identify TB in various populations, including adults and children at risk, such as those living with HIV or in marginalized communities. The trial will take place in several countries, including Bangladesh, Brazil, and Nigeria.

To participate in the trial, individuals must meet certain criteria. For children aged 1 to 15, they should show signs of possible TB, like a persistent cough or fever lasting more than two weeks. Adults over 15 must also meet specific criteria, such as being at risk of TB due to close contact with someone infected. Participants will undergo testing and may be asked to follow up for ongoing care. It's important to know that the trial is not yet recruiting participants, but it aims to help improve TB diagnosis and treatment for those who need it most.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Children (1 - 15 years):
• The sampling frame will consist of health-seeking children presenting at participating study site health facilities who:
• • Are between 12 months and 15 years of age
• * have presumptive TB based on at least one criterion among the following:
• • Persistent cough for more than 2 weeks
• • Persistent fever for more than 2 weeks
• • Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age \< 2)
• • Failure of broad-spectrum antibiotics for treatment of pneumonia to improve symptoms and signs
• • Suggestive CXR features OR
• • History of contact with a person with TB and any of the symptoms listed above with a shorter duration (\< 2 weeks), if the child is HIV infected or presents with Severe Acute Malnutrition
• • A parent or guardian present at the time of enrollment to provide signed informed consent and assent signed by children \> 7 years old.
• Exclusion Criteria for children:
• • - \> 5 days of anti-TB treatment in the last 3 months or individuals receiving TB preventive therapy
• • Children \<12 months old
• • Exhibiting any danger signs: Danger signs for children \< 5years: unable to eat or drink, vomiting up everything, severe dehydration, severe pallor, stridor, SpO2 \>90%, respiratory distress, seizures, profound lethargy or coma, continuously irritable, neck stiffness or bulging fontanelle, fever \>39C, severe acute malnutrition (weight-for-height in Z-score less than -3 or mid-upper arm circumference less than 115 mm.)
• • Danger signs for children \>=5 years: diarrhoea with severe dehydration, severe pallor, shock (cold extremities, capillary refill time \>3 seconds, weak and fast pulse), obstructed or absent breathing, respiratory distress, central cyanosis, coma (or seriously altered level of consciousness), seizures, restless, continuously irritable, fever \>39C, severe acute malnutrition (weight-for-height in Z-score less than -3 or mid-upper arm circumference less than 115 mm.)
• • Inclusion criteria for adults attending stationary health facilities The sampling frame will consist of health-seeking persons presenting at participating study site health facilities who are
• • Age 15+ years,
• • PLHIV irrespective of their CD4 count and antiretroviral therapy (ART) status
• • At risk of TB disease due to being a close contact of a person with infectious TB as defined by WHO
• • People with positive WHO-recommended four-symptom screen (W4SS) or parenchymal abnormalities on chest x-ray regardless of whether they are known to be PLHIV, are known to be HIV-negative, or their HIV status is unknown
• • Written informed consent and agreement to follow-up after enrolment (e.g. not planning to relocate)
• • A parent or guardian present at the time of enrollment to provide signed informed consent and assent signed for those aged 15 years to age of majority.
• Exclusion criteria for adults attending stationary health facilities:
• • Current anti-TB treatment (counting from the third dose)
• • Any anti-TB treatment within 60 days prior to enrolment
• • Any TB preventive therapy within 6 months prior to enrolment.
• • Exhibiting any danger signs: respiratory rate \> 30/min and/or fever \> 39°C and/or pulse rate \> 120/min and/or unable to walk.
• • INCLUSION CRITERIA FOR PARTICIPANTS IN REFUGEE CAMPS OR INTERNALLY DISPLACED The sampling frame will consist of health-seeking persons resident in official refugee camps who have crossed international borders from other countries; or internally displaced individuals (IDPs), defined as persons forced or obliged to flee or to leave their homes to avoid the effects of armed conflict, situations of generalized violence, violations of human rights or natural or human-made disasters, and who have not crossed an internationally recognized state border. IDPs can be recruited from refugee camps or among individuals sharing accommodation with local residents. At the time they are presenting at participating study site health facilities. The same inclusion criteria will be used, as described above for individuals attending health facilities.
• • EXCLUSION CRITERIA FOR PARTICIPANTS IN REFUGEE CAMPS OR INTERNALLY DISPLACED
• • Current anti-TB treatment (counting from the third dose)
• • Any anti-TB treatment within 60 days prior to enrolment
• • Any TB preventive therapy within 6 months prior to enrolment
• • Individuals who intend to leave the local area in the short term and have no means of contact.
• • INCLUSION CRITERIA FOR NOMADIC POPULATIONS Participants will be selected using active case finding35 consisting primarily of a series of community screening camps targeting the state's nomadic population. Nomadic populations in Nigeria are defined as a member of a groups of people who have no fixed home and move according to the seasons from place to place in search of food, water, and grazing land and are usually herders with traditional hierarchies.
• • The dates and locations of screening days will usually coincide with community market days, agreed upon after consultation with nomadic community leaders.
• • EXCLUSION CRITERIA FOR NOMADIC POPULATIONS
• • Current anti-TB treatment (counting from the third dose)
• • Any anti-TB treatment within 60 days prior to enrolment
• • Any TB preventive therapy within 6 months prior to enrolment
• • Individuals who intend to leave the local area in the short term and have no means of contact.
• • INCLUSION CRITERIA FOR INFORMAL SETTLEMENTS, URBAN VULNERABLE GROUPS AND THE RURAL POOR Participants will be selected using active case finding consisting primarily of a series of community screening activities targeting urban vulnerable populations (persons aged \>55 years, urban poor, economic migrants and diabetics) and the rural poor. Screening will be conducted on dates and in locations as agreed with community leaders, depending on the setting.
• • EXCLUSION CRITERIA FOR INFORMAL SETTLEMENTS, URBAN VULNERABLE GROUPS AND THE RURAL POOR
• • Current anti-TB treatment (counting from the third dose)
• • Any anti-TB treatment within 60 days prior to enrolment
• • Any TB preventive therapy within 6 months prior to enrolment
• • Individuals who intend to leave the local area in the short term and have no means of contact.