AZD9773 Dose Escalation Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Severe Sepsis

In brief

This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis.

Key facts

Study ID

NCT00615017

Run by

AstraZeneca

People needed

70

Starts

2008-01-01

Expected to finish

2009-07-01

Last updated by the study team

2013-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical evidence of infection requiring treatment with parenteral antibiotics
• Patients must meet multiple Systemic Inflammatory Response Syndrome (SIRS) criteria
• Patients must meet criteria for cardiovascular and/or respiratory dysfunction
• Sepsis (infection plus SIRS criteria) must be present prior to organ dysfunction

You may not qualify if…

• Moribund and death is considered imminent, or patient not expected to survive 90 days because of underlying medical condition, or classified as Do Not Resuscitate or Do Not Treat
• Patient cannot attain a MAP >60 mmHg when measured via an arterial line and/or a Systolic Blood Pressure (SBP) >80 mmHg in the presence of vasopressors and iv fluids for a period of ≥2 hours
• Receiving immunosuppressants, or high dose steroids within 2 months of provision of informed consent
• Any history of hypersensitivity reaction to sheep products, latex, papain or papaya, or chymopapain or previously administered antivenom manufactured using ovine serum, digoxin immune fab (DigiFab™ , DIGIBIND® ), crotalidae polyvalent immune fab (ovine) (CroFab™ ), or other sheep derived product.
• Treatment with anti Tumor-Necrosis-Factor (anti-TNF) antibodies within 8 weeks before provision of written informed consent.

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Newark, Delaware, United States
• Research Site — Bay Pines, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Oak Park, Illinois, United States
• Research Site — Peoria, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Hazard, Kentucky, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Camden, New Jersey, United States
• Research Site — Newark, New Jersey, United States
• Research Site — Brooklyn, New York, United States
• Research Site — New York, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Greensboro, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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