NCT07517471Toborzás még nem indult
Start4All SCREEN-TB PROTOCOL
Start4All - Start Taking Action for TB Diagnosis SCREEN-TB
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 8.
Rövid összefoglaló (regiszter, angolul)
Tuberculosis (TB) remains the leading cause of death from a single infectious agent globally, with millions of people still undiagnosed or diagnosed late. Conventional case-finding strategies rely heavily on symptom screening using the WHO Four-Symptom Screen ((W4SS; comprising any one of current cough, fever, night sweats, or weight loss) and sputum testing, but these approaches miss a substantial proportion of individuals with active TB disease, particularly those who are asymptomatic or unable to produce sputum. Missed and delayed diagnoses drive ongoing transmission and undermine global TB elimination goals. Recent evidence has shown that diagnostic tools which are more accessible, even if somewhat less sensitive, can still substantially improve TB case detection by reducing diagnostic loss associated with access barriers. This suggests that near point-of-care (NPOC) tests might be highly cost-effective in many settings, because the gains from earlier diagnosis, reduced delays, and broader reach could outweigh losses from slightly lower accuracy. The purpose of this study is to evaluate new, symptom-agnostic screening and diagnostic approaches that can be implemented at lower-level health facilities in high TB-burden, low and middle-income (LMIC) countries for adults ≥15 years and 10-14 years old young adolescents
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 37000 (tervezett)
- Első benyújtás
- 2026. febr. 4.
- Kezdés
- 2026. ápr.
- Elsődleges befejezés
- 2027. jan.
- Fő szponzor
- Liverpool School of Tropical Medicine
- Betegségek
- Tuberkulózis
- NCT-szám
- NCT07517471
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 37000
- 2026. ápr. és az elsődleges befejezés (2027. jan.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Ki nem vehet részt
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Korábbi kezelés
- Current TB treatment
- o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment.
- Recent TB preventive therapy
- o Receipt of TB preventive therapy within the last 6 months prior to enrolment.
- Duplicate enrolment o Previous enrolment in SCREEN-TB.
Más betegség
- Clinical danger signs
- o Presence of severe illness at screening, including but not limited to: Respiratory rate >30/min Fever >39°C Pulse rate >120/min Inability to walk unaided
Életkor
- Age
- o Below 10 years at enrolment
Egyéb
- Screening eligibility
- o Do not screen positive on any tools.
- Consent and follow-up
- o Unable or unwilling to provide written informed consent (and assent where applicable) or unwilling to agree to follow-up visits.
Kiket keres a vizsgálat
- Age
- Adults aged 15 years and above or
- Adolescents aged 10-14 years
- Facility setting
- o Participating healthcare facilities (e.g., primary health centres, district hospitals), including both rural and urban facilities.
- Screening eligibility
- o All individuals presenting to the facility, regardless of symptoms or ability to produce sputum, will be eligible for inclusion.
- Consent
- Written informed consent (and assent for adolescents (10-14 years) and adults (≥15 - 17 years) if included) must be obtained according to local ethics and regulatory requirements.
Életkor a regiszterben: 10 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.