Clinical trial NCT00630656: Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Sepsis
Keywords: sepsis
talactoferrin
lactoferrin
recombinant human lactoferrin
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Onset of severe sepsis within the previous 24 hours
* Must be receiving antibiotic therapy
* Informed consent form signed by patient, legal next-of-kin or legal guardian
* Able to take medication by mouth or feeding tube

Exclusion Criteria:

* Receipt of investigational medication within 4 weeks prior to participation in the study
* Pregnant or breast-feeding
* Severe congestive heart failure
* Known severe HIV infection
* Presence of severe burns
* Patients on high dose immunosuppressants
* Patients whose death is considered imminent
* Patients whose life expectancy for concurrent illness is less than 6 months
* Severe hypoxic encephalopathy or persistent vegetative state
* Severe liver disease
* Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Primary outcomes:
measure: All-cause mortality
timeFrame: 28-day
Secondary outcomes:
measure: All-cause mortality
timeFrame: 3 months
measure: All-cause mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Sylmar
country: United States
facility: Olive View- UCLA Medical Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Washington
country: United States
facility: The George Washington University Hospital
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Park
country: United States
facility: West Suburban Medical Center
state: Illinois
city: New Albany
country: United States
facility: Floyd Memorial Hospital and Health Services
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinic
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Montauban
country: France
facility: Centre Hospitalier de Montauban
city: Saint-Michel
country: France
facility: Centre Hospitalier Angouleme
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Cataluña
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Cataluña
Study officials:
affiliation: Baylor College of Medicine
name: Kalpalatha K Guntupalli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551.