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| ID | Type | Description | Link |
|---|---|---|---|
| NIH grant 1R44GM077816-01A2 |
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Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Talactoferrin alfa |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talactoferrin alfa | Drug | 15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 28-day |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 3 months | |
| All-cause mortality | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kalpalatha K Guntupalli, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States | ||
| UC Davis Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23425819 | Derived | 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. |
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| Placebo | Drug | Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit |
|
| Sacramento |
| California |
| 95817 |
| United States |
| Olive View- UCLA Medical Center | Sylmar | California | 91342 | United States |
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
| The George Washington University Hospital | Washington D.C. | District of Columbia | 20037 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| West Suburban Medical Center | Oak Park | Illinois | 60302 | United States |
| Floyd Memorial Hospital and Health Services | New Albany | Indiana | 47105 | United States |
| University of Iowa Hospitals and Clinic | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| St. John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27517 | United States |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pittsburgh Medical Center Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Intermountain Medical Center | Salt Lake City | Utah | 84143 | United States |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Centre Hospitalier de Montauban | Montauban | 82013 | France |
| Centre Hospitalier Angouleme | Saint-Michel | 16470 | France |
| Helios Klinikum Erfurt | Erfurt | 99089 | Germany |
| Hospital de Sabadell | Sabadell | Catalonia | 08208 | Spain |
| Hospital Mutua de Terrassa | Terrassa | Catalonia | 08221 | Spain |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C515276 | talactoferrin alfa |
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