ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children (ERNIE4)
Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study
調査の概要
詳細な説明
The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely children presenting to ambulatory care.
The cross-sectional cohort study will compare an innovative urine test with conventional dipstick testing to establish their relative accuracy to diagnose urinary tract infections, and construct an algorithm consisting of clinical features, urine test results and CRP point-of-care testing to identify serious infections. The longitudinal follow-up study will describe illness trajectories of children with an intermediate CRP test result (5-80 mg/L) at first contact.
The study will run in general practices and community paediatrics in Flanders. Recruitment to the study is expected to last 18 months, with each patient entering the study only once. Children and their parents/guardians will be approached for possible participation in the study by practice staff. There is only one study visit.
Those who agree to participation via written informed consent will have demographics and clinical features recorded. All children will be asked to provide a urine sample on study entry. Subsequently, CRP point-of-care testing will be conducted in all children testing positive on a clinical prediction rule, and in a random sample of children testing negative on that rule. Follow-up information for all children will be collected using general practice notes, hospital records and direct patient/parent contact.
Treatment and other management decisions will be left to the treating physicians' discretion.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Leuven、ベルギー、3000
- KU Leuven
-
-
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
説明
Inclusion Criteria:
- Aged 3 months to 18 years
- Presenting to a general practice or community paediatrics
- Acute illness of a maximum of 10 days
- Parent or guardian is willing and able to give informed consent for participation
Exclusion Criteria:
- Clinically unstable warranting immediate care
- Urinary catheter in situ
- Immunosuppressant medication taken in the previous 30 days
- Trauma is the main presenting problem
- Antibiotics taken in the previous 7 days
- Children who present to community paediatrics as a result of direct GP referral
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
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：CRP in all
All children will undergo a CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott). There will be only 1 test at study entry |
CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)
|
|
実験的：CRP in high risk children only
Children who are positive on a clinical prediction rule for serious infections in children will undergo CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott). There will be only 1 test at study entry |
CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)
|
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 |
|---|---|---|
|
Urinary tract infection
時間枠：3 days
|
The number of children with a urinary tract infection based on urine culture
|
3 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serious infections
時間枠：30 days
|
The number of children admitted to hospital for a serious infection which can be pneumonia, sepsis, meningitis, pyelonephritis, osteomyelitis or appendicitis
|
30 days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Final diagnosis
時間枠：30 days
|
For children not admitted to hospital, the final diagnosis based on all available clinical information from ambulatory care assessment over 30 days after the index date.
|
30 days
|
|
Duration of symptoms
時間枠：30 days
|
For all children, the duration of symptoms after the index date based on patient diaries
|
30 days
|
|
Healthcare resource use
時間枠：30 days
|
For all children, re-consultation rates in ambulatory care after the index date
|
30 days
|
|
Healthcare resource use
時間枠：30 days
|
For all children, ED attendance after the index date
|
30 days
|
|
Healthcare resource use
時間枠：30 days
|
For all children, hospital admission after the index date
|
30 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ann Van den Bruel, MD PhD、ACHG, KU Leuven
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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