IC14 Antibodies to Treat Individuals With Acute Lung Injury
Acute Lung Injury Clinical Trials Incubator Unit
調査の概要
詳細な説明
BACKGROUND:
This study will use IC14, a recombinant chimeric monoclonal antibody (mAb) recognizing CD14, to block CD14 medicated cellular activation in patients with sepsis-induced ALI. Research results of antibody interaction with CD14 suggest that CD14 has a central role in the recognition of bacterial products and the induction of innate immune responses. Although beneficial, when this response is combined with a component of alveolar stretch it may induce an exaggerated response that can be harmful. This study will implement strategies to block CD14-mediated cellular activation and will evaluate whether this strategy has a beneficial effect in reducing alveolar inflammatory response, mechanical ventilation days, multiple organ failure, and severity of organ dysfunction in patients with sepsis-induced ALI.
DESIGN NARRATIVE:
The primary outcome of this study will be alveolar lavage concentrations of interleukin-8 that will be measured post-treatment at Days 2 and 3, and Days 6 to 8.
The key secondary outcomes of this study will be: 1) Worst Murray Lung Injury Score (measured at Days 1 through 7, and Day 28); 2) Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28); 3) Infections-nosocomial and/or surgical site infections (measured at Day 28); 4) Ventilator-free days (measured at Day 28); and 5) Mortality (measured at Day 28).
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Washington
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Seattle、Washington、アメリカ、98104-2499
- University of Washington
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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
説明
Inclusion Criteria:
Presence of ALI, defined as the following:
- Acute onset (less than 28 days from study entry)
- PaO2/FiO2 of less than 300
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
- Requirement for positive pressure ventilation via endotracheal tube
- No clinical evidence of left atrial hypertension
- Clinical indication for antimicrobial therapy at the time of randomization
- Anticipated duration of mechanical ventilation greater than 48 hours
Exclusion Criteria:
- Treatment with a drug or device within 30 days prior to study entry that has not received regulatory approval at the time of study entry
- Does not meet safety criteria for bronchoscopic alveolar lavage either at baseline or is anticipated to be too high a risk for lavage on Day 1 of the study
- Intubation for cardiopulmonary arrest
- Intubation for status asthmaticus, pulmonary embolus, or myocardia infarction
- Anticipated survival less than 48 hours from intubation
- Anticipated survival less than 28 days due to pre-existing medical condition
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:処理
- 割り当て:ランダム化
- マスキング:ダブル
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 |
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Alveolar lavage concentrations of interleukin-8 (measured post-treatment at Days 2, 3, 6, 7, and 8)
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二次結果の測定
結果測定 |
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Ventilator-free days
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Worst Murray Lung Injury Score
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Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28)
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Infections-nosocomial and/or surgical site infections
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Mortality (measured at Day 28)
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Margaret Neff, MD、University of Washington
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
IC14の臨床試験
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Implicit Bioscience募集
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Implicit BioscienceMassachusetts General Hospital利用できない
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Implicit BioscienceRoyal Brisbane and Women's Hospital完了
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Implicit Bioscience利用できない
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National Institute of Allergy and Infectious Diseases...PPD; University of Washington; Vanderbilt University Medical Center; Implicit Bioscience終了しました
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Universitaire Ziekenhuizen KU LeuvenIpsen募集