Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

IC14 Antibodies to Treat Individuals With Acute Lung Injury

12. maj 2017 opdateret af: University of Washington

Acute Lung Injury Clinical Trials Incubator Unit

This is a phase II, randomized, double-blind, placebo-controlled, safety and efficacy study of a recombinant chimeric monoclonal antibody against CD14 (IC14) in hospitalized patients with acute lung injury (ALI).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: IC14

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Washington
  - Seattle, Washington, Forenede Stater, 98104-2499
    - University of Washington

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Presence of ALI, defined as the following:
1. Acute onset (less than 28 days from study entry)
2. PaO2/FiO2 of less than 300
3. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
4. Requirement for positive pressure ventilation via endotracheal tube
5. 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Alveolar lavage concentrations of interleukin-8 (measured post-treatment at Days 2, 3, 6, 7, and 8)

Sekundære resultatmål

Resultatmål
Ventilator-free days
Worst Murray Lung Injury Score
Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28)
Infections-nosocomial and/or surgical site infections
Mortality (measured at Day 28)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

Studiestol: Margaret Neff, MD, University of Washington

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2005

Studieafslutning (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først indsendt

3. oktober 2005

Først indsendt, der opfyldte QC-kriterier