CytoFab (AZD9773) Dose Escalation Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00615017

Purpose

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

Condition	Intervention	Phase
Severe Sepsis	Drug: AZD9773 (CytoFab)	Phase II

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety Study
Official Title:	A Placebo-Controlled, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of Single and Multiple Intravenous Infusions of CytoFab (AZD9773) in Patients With Severe Sepsis

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary purpose of the study is to evaluate the safety profile of AZD9773 as evidenced by adverse events, serious adverse events, laboratory safety assessments, vital signs, 12-lead ECG and physical examination. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Additional outcome variables include general assessment of sepsis care, PK, and PD. [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

intravenous infusions

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 and arterial line and/or a 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 weeks 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-TNF antibodies within 8 weeks before provision of written informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615017

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Show 28 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Steven Simonson, MD	AstraZeneca
Study Director:	Wayne Dankner, MD	Parexel

More Information

Responsible Party:	AstraZeneca ( Paul Newell / Medical Science Director )
Study ID Numbers:	D0620C00004
Study First Received:	January 31, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00615017
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Sepsis
septic shock
Systemic Inflammatory Response Syndrome

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 14, 2009