Triage UltraSound in Tb Endemic Regions (TrUST)
Point-of-care Ultrasound for the Diagnosis and Risk Stratification of Lower Respiratory Tract Infections in TB Endemic Regions: a Multicenter Prospective Cohort Study
調査の概要
詳細な説明
Design International multicentre prospective cohort study
Setting This study aims to explore the performance of POCUS in a pre-hospital setting in countries with different prevalences of HIV: South- Africa (high prevalence), Benin (low prevalence) and Mali (low prevalence).
Study procedures Pre-recruitment training Before initiating the study, participating clinicians will benefit from lung ultrasound (LUS) and POCUS protocols for extra pulmonary TB (FASH+ exam) training with a field expert. The participating clinicians are required to pass a final expert test before start of patient recruitment and to have a minimum of 20 supervised US.
Inclusion (Day 0) Patients inclusion will be performed over a period of 18 to maximum 24 months. Recruitment will stop before the anticipated end if the inclusion of 1000 patients is reached.
Clinical data Data collected include demographic characteristics (age, sex, occupation etc.), past medical history (previous TB, Coronavirus Disease (COVID), vaccination status, documented past episodes of COVID-19, HIV status,…), symptoms (respiratory symptoms, specific COVID-19 symptoms (from the Centers for Disease Control COVID checklist), specific pulmonary TB symptoms (from the CDC TB checklist) and routine clinical examination findings (vital parameters, oxygen saturation, lung auscultation,…).
Laboratory analyses
Analyses performed on site:
- HIV screening with a serial two rapid test algorithm as per World Health Organization (WHO) guidelines : Screening with Alere Determine combo®; if positive, confirmation by a second rapid test First Response® HIV 1-2-0, CD4 count and/or Viral load as per national guidelines.
- Sputum for GeneXpert Mycobacterium Tuberculosis (MTB)/rifampicine (RIF) assay
- Induced sputum for a new GeneXpert MTB assay if a routine spot and second morning GeneXpert MTB is negative and sputum quality was low (salivary) as per WHO consolidated guidelines
- Sputum for Gram stain and standard bacteriological culture
- Nasopharyngeal swab for Severe Acute Respiratory Syndrome Coronovirus (SARS-CoV-2) real-time polymerase chain reaction (RT-PCR) (Cepheid Xpert Xpress SARS-CoV-2) Since the additional diagnostic yield of mycobacterial culture is shown to be very low in adult patients with cough in Benin, it is reserved for GenXpert MTB/RIF resistant cases, specimens other than sputum (e.g. pleural effusions, where sensitivity of GeneXpert MTB/RIF is low) and patients with treatment failure. Mycobacterial culture will be done on solid medium (Löwenstein-Jensen).
Analyses performed retrospectively on stored samples:
- Nasopharyngeal swab: PCR for influenza
- Sputum: syndromic molecular panel targeting influenza and atypical bacteria. Radiological examinations
- Chest X-Ray (CXR) - face: digital format will be stored
- LUS exam using a standard point-of-care ultrasound device (ultrasound-on-a-chip), LUS will be recorded according to a standard 12-point acquisition protocol with 4 additional apical sites (2 subclavicular and 2 axillary) for improved TB detection.
- This involves scanning both apexes, the anterior and posterior apexes, anterior superior, anterior inferior, posterior superior, posterior inferior and lateral thorax regions
- FASH plus exam using a standard point-of-care ultrasound device. The FASH plus protocol will be performed in a standardized manner as previously described.
All US images captured will be digitally recorded and transferred via a secured internet connection along with relevant metadata to a secure server for storage. For study quality control purposes, the quality of the image and the interpretation of a random sample of images will be evaluated retrospectively by an experienced radiologist.
Clinician-evaluated LUS and FASH All LUS and FASH exams will be read by 2 independent readers blinded to patients diagnosis and outcome. A third reader will solve discrepancies between the two readers. They will fill in a standardized LUS and FASH report.
AI-evaluated LUS and FASH The US images will be further used for secondary studies developing deep learning algorithms for LUS and FASH diagnosis.
Follow-up (D7 and D28) Patients will receive a follow-up phone call by the study nurse on day 7 and day 28. Data on the clinical evolution are collected: hospitalization, non-invasive ventilation, intubation, death.
Follow-up of TB treatment failures and deaths until D180 TB patients will be followed in the national TB register and treatment failures will be recorded at 6 months of treatment (according to national guidelines).
Deaths will be recorded until D180 as well.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Noémie Boillat-Blanco, MD-PhD, PD
- 電話番号:+41 (0)79 556 16 86
- メール:noemie.boillat@chuv.ch
研究連絡先のバックアップ
- 名前:Veronique Suttels, MD
- 電話番号:+229 97 44 87 82
- メール:veronique.suttels@outlook.com
研究場所
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Atlantic
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Cotonou、Atlantic、ベナン
- 募集
- CNHUPPC
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コンタクト:
- Gildas Agodokpessi, Prof
- メール:aggildas@yahoo.fr
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Bamako、マリ
- まだ募集していません
- CHU point G
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コンタクト:
- Khadidia Ouattara, MD
- メール:zankhadi@gmail.com
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Acornhoek、南アフリカ
- 募集
- Wits Rural University
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コンタクト:
- Jacques Du Toit
- メール:jacques.dutoit1@wits.ac.za
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
- Benin: 6'500 cumulative total detected and declared COVID-19 cases since march 2020 to date (NB true COVID-19 incidence unknown due to undertesting), TB incidence 55/100'000/year, low HIV (prevalence < 2%)
- South Africa: 1,522'697 cumulative total detected and declared COVID-19 cases since march 2020 to date TB incidence 615/100.000/year, high HIV (prevalence approximately 20%)
- Mali: 30'420 cumulative total detected and declared COVID-19 cases since march 2020 to date (NB true COVID-19 incidence unknown due to undertesting), TB incidence 52/100'000/year, low HIV (prevalence < 2%)
説明
Inclusion Criteria:
- Age ≥18 years
- Suspicion of lower respiratory tract infection (defined as presence of cough with at least one of the following: fever, dyspnea/tachypnea, sputum production, chest pain, hemoptysis or cachexia)
Exclusion Criteria:
- Cough/dyspnea from a definite non-infectious origin (cardiac, asthmatic...)
- Inability to cooperate with ultrasound procedure
- Inability to sign informed consent (third witness procedure available for illiterate patients)
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Benin1
Benin urban recruitment site National teaching hospital for tuberculosis, outpatient emergency department
|
POCUS of lungs, pericardium and abdomen
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Mali1
Mali urban recruitment site University Hospital Bamako, outpatient emergency department
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POCUS of lungs, pericardium and abdomen
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South-Africa1
South-Africa rural recruitment site 1 Tintswalo hospital, outpatient emergency department
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POCUS of lungs, pericardium and abdomen
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South-Africa2
South-Africa rural recruitment site 2 Zithulele hospital, outpatient emergency department
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POCUS of lungs, pericardium and abdomen
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Sensitivity of LUS for the detection of TB
時間枠:18 to 24 months
|
For LUS, each lung quadrant will be scored using a 6 feature LUS score (modified Soldati score) ranging from 1 (aerated lung), 2 (interstitial syndrome), 3 (sub centimeter pleural lesions), 4 (lung consolidation), 5 (pleural effusion) to 6 (pneumothorax).
Sensitivity of LUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards
|
18 to 24 months
|
Specificity of LUS for the detection of TB
時間枠:18 to 24 months
|
For LUS, each lung quadrant will be scored using a 6 feature LUS score (modified Soldati score) ranging from 1 (aerated lung), 2 (interstitial syndrome), 3 (sub centimeter pleural lesions), 4 (lung consolidation), 5 (pleural effusion) to 6 (pneumothorax).
Sensitivity of LUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards
|
18 to 24 months
|
Sensitivity of FASH PLUS for the detection of TB
時間枠:24 to 36 months
|
For the pericardial and abdominal ultrasound, a score according to the FASH PLUS protocol will be attributed ranging from 0 (no pathology) to 6 (presence of pericardial effusion, abdominal adenopathies, pleural effusion, splenic lesions, hepatic lesions, ascites).
Sensitivity of FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
|
24 to 36 months
|
Specificity of FASH PLUS for the detection of TB
時間枠:24 to 36 months
|
For the pericardial and abdominal ultrasound, a score according to the FASH PLUS protocol will be attributed ranging from 0 (no pathology) to 6 (presence of pericardial effusion, abdominal adenopathies, pleural effusion, splenic lesions, hepatic lesions, ascites).
Specificity of FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
|
24 to 36 months
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Sensitivity of combined LUS and FASH PLUS features for the detection of TB
時間枠:24 to 36 months
|
Sensitivity of combined LUS and FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
|
24 to 36 months
|
Specificity of combined LUS and FASH PLUS features for the detection of TB
時間枠:24 to 36 months
|
Specificity of combined LUS and FASH PLUS score for the diagnosis of TB using microbiological tests (GenXpert MTB/RIF for HIV negative patients, mycobacterial culture for HIV patients and extra-pulmonary samples) as reference standards.
|
24 to 36 months
|
Sensitivity of AI-interpreted LUS for the detection of TB
時間枠:24 to 36 months
|
LUS images will be scored binary by microbiological-label trained algorithms as TB or not TB.
Prediction: Sensitivity of AI-assisted interpretation LUS for the detection of TB using microbiological tests as reference standards
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24 to 36 months
|
Specificity of AI-interpreted LUS for the detection of TB
時間枠:24 to 36 months
|
LUS images will be scored binary by microbiological-label trained algorithms as TB or not TB.
Prediction: Specificity of AI-assisted interpretation LUS for the detection of TB using microbiological tests as reference standards
|
24 to 36 months
|
Sensitivity of AI-interpreted FASH PLUS for the detection of TB
時間枠:24 to 36 months
|
FASH PLUS images will be scored binary by microbiological-label trained algorithms as TB or not TB.
Prediction: Sensitivity of FASH PLUS for the detection of TB using microbiological tests as reference standards
|
24 to 36 months
|
Specificity of AI-interpreted FASH PLUS for the detection of TB
時間枠:24 to 36 months
|
FASH PLUS images will be scored binary by microbiological-label trained algorithms as TB or not TB.
Prediction: Specificity of FASH PLUS for the detection of TB using microbiological tests as reference standards
|
24 to 36 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of POCUS
時間枠:12 months
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Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of POCUS to assess its feasibility, sustainability and acceptability
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12 months
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Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of AI clinical decision support
時間枠:12 months
|
Qualitative assessment using semi-structured interviews (based on grounded theory methods) with end users of the barriers and facilitators of the implementation of AI clinical decision support to assess its feasibility, sustainability and acceptability
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12 months
|
協力者と研究者
協力者
捜査官
- 主任研究者:Mary-Anne Hartley, MD-PhD、Ecole Polytechnique Fédérale de Lausanne
- 主任研究者:Noémie Boillat Blanco, MD-PhD、Lausanne University Hospital
- 主任研究者:Veronique Suttels, MD、Lausanne University Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CGRB11362
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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