感染症の臨床徴候が疑われる新生児における抗生物質の過剰使用を減らすためのバイオマーカーの性能を検証 (RUBIS)
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).
Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be related to other neonatal conditions such as prematurity and birth defects, are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity. This explains why excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality.
A previous study (EMERAUDE) aimed to identify new biomarkers to early exclude the diagnosis of LOS, in order to limit antibiotic overuse. This study including 230 neonates revealed high performances of IL6, IL10, NGAL and combinations of PCT/IL10 and PTX3/NGAL.
The main objective of the present study will be to validate the performances of these biomarkers in another cohort. The secondary objectives will be to explore transcriptomic biomarkers and salivary biomarkers.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Marine BUTIN, Pr
- 電話番号：+33 4 27 85 52 84
- メール：marine.butin@chu-lyon.fr
研究連絡先のバックアップ
- 名前：Sophie TROUILLET-ASSANT
- 電話番号：+33 4 72 67 87 80
- メール：sophie.trouillet-assant@chu-lyon.fr
研究場所
-
-
-
Bron、フランス、69500
- 募集
- neonatal Intensive care unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, France
-
コンタクト：
- Marine BUTIN, Pr
- 電話番号：+33 4 27 85 52 84
- メール：marine.butin@chu-lyon.fr
-
Grenoble、フランス、38700
- 募集
- Hôpital Couple-Enfant - CHU Grenoble Alpes
-
コンタクト：
- LAYLI ALIN, MD
- 電話番号：00334 27 85 52 84
- メール：lalin@chu-grenoble.fr
-
Nantes、フランス、44300
- 募集
- Neonatal intensive care unit, Hôpital femme-maternité
-
コンタクト：
- FLAMANT Cyril, Pr
- 電話番号：+33 2.40.08.34.83
- メール：cyril.flamant@chu-nantes.fr
-
-
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
Newborns aged ≥ 7 days hospitalized in one of the 2 neonatal intensive care units (Nantes or Lyon) for whom an infection is suspected.
説明
Inclusion Criteria:
- Patient hospitalized in the NICU of one of the two recruiting centers at the time of inclusion
- Patients aged ≥ 7 days
- Patients weighted ≥ 500 g the day of blood sample
- patients with suggestive signs of LOS including at least one of the following:Fever > 38°C; tachycardia > 160bpm; capillary refill time > 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome, bloating; vomiting; rectal bleeding; hypotonia; lethargy; seizures without other obvious cause; increased ventilatory support and/or increased FiO2; cutaneous rash; inflammation at the needle-puncture site of the central venous catheter; or any other condition for which the clinician suspected an infection
- patients with a standard of care blood sampling, including at least a blood culture;
Exclusion Criteria:
- Patient treated with antibiotics for a bacteriologically confirmed infection at the time of sampling or within 48 hours prior to sampling
- Patient who underwent surgery within the previous 7 days
- Patients vaccinated within the previous 7 days
- Patient who received treatment with systemic corticosteroid therapy in the 48 hours prior to sampling
- Patient with severe combined immunodeficiency
- Opposition from parent(s)/guardian(s)
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
Diagnosis of late onset sepsis
時間枠：72 hours maximum after inclusion
|
The primary outcome measure will be determined by an independent adjudication committee that will classify the patients into the following categories : infection, non infected or undetermined. This committee will be blinded to the biomarkers of the study. It will be composed of two neonatologists and a pediatrician specialized in pediatric infectious diseases. The diagnostic performance of the biomarkers combination will be based on the adjudication committee classification (gold standard). |
72 hours maximum after inclusion
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。