Severe SepsisPhase 2/3OASISNCT01273779
Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
A Phase 2/3 study testing Talactoferrin alfa in people with Severe Sepsis, run by Agennix at 100 sites in 10 countries.
Trial summary
Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Talactoferrin alfa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,280 participants
- Where
- 100 sitesin 10 countries
- Study dates
- Jun 2011to Dec 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 or authorized representatives according to local rules or regulations
- Able to take liquid medication by mouth or feeding tube
Who cannot join
- 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
Show all 12Show fewer
- 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
- Chronically bed bound
- Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support
Trial locations and contacts
100 sites in 10 countries.
100 sites in 10 countries
United States34 sites
University of Alabama - Birmingham
Birmingham, Alabama, 35249
Cooper University Hospital
Camden, New Jersey, 08103
Bay Area Chest Physicians
Clearwater, Florida, 33756
Riverside Methodist Hospital
Columbus, Ohio, 43214
Denver Health Medical Center
Denver, Colorado, 80204
Henry Ford Hospital
Detroit, Michigan, 48202
Texas Tech Health Science Center
El Paso, Texas, 79905
Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401
Baylor College of Medicine
Houston, Texas, 77030
Eastern Idaho Medical Consultants
Idaho Falls, Idaho, 83404
Methodist Research Institute
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Wisconsin Medical School
Madison, Wisconsin, 53792
Maricopa Medical Center
Maricopa, Arizona, 85008
University of Tennessee
Memphis, Tennessee, 38163
Providence Hospital
Mobile, Alabama, 36608
LDS Hospital
Murray, Utah, 84157
Christiana Care Health Services
Newark, Delaware, 19718
West Suburban Hospital Medical Center
Oak Park, Illinois, 60302
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
St. Joseph Hospital
Orange, California, 92868
Peoria Pulmonary Associates
Peoria, Illinois, 61603
Cancer Institute, Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Rhode Island Hospital
Providence, Rhode Island, 02903
Sharp Memorial Hospital
San Diego, California, 92123
Baystate Medical Center
Springfield, Massachusetts, 01199
St. Johns Mercy Medical Center
St Louis, Missouri, 63141
Stanford University Hospital
Stanford, California, 94305-5117
UCLA Medical Center
Sylmar, California, 91342
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27517
France12 sites
Hôtel Dieu
Angers, 49933
Centre Hospitalier Victor Dupouy
Argenteuil, 95107
Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
La Roche-sur-Yon, 85925
Hôpital Albert Michallon / La Tronche
La Tronche, 38700
Hôpital Universitaire Dupuytren
Limoges, Limoges, 87042
Centre Hospitalier de Montauban
Montauban, 82013
Hôpital de la Source
Orléans, 45067
Hôpital Cochin
Paris, 75679
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hôpital de la Miletrie
Poitiers, 86021
Centre Hospitalier Angouleme
Saint-Michel, 16470
Hôpital Bretonneau
Tours, 37044
Belgium10 sites
Hôpitaux IRIS Sud
Brussels, 1050
Hôpital Erasme
Brussels, 1070
UZ Brussel
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels, 1200
Ziekenhuis Oost-Limburg
Genk, 3600
UZ Gent
Ghent, 9000
CHU de Liège
Liège, 4000
Centre Hospitalier de Dinant
Mons, 7000
Clinique Saint-Pierre
Ottignies, Ottignies, 1340
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, 5530
Canada9 sites
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
Kingston General Hospital
Kingston, Ontario, K7L 2V7
SMBD - Jewish General Hospital
Montreal, Quebec, H3T 1C5
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
Windsor Regional Hospital
Windsor, Ontario, N8X 3V6
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Grace Hospital
Winnipeg, Manitoba, R3J 3M7
Spain9 sites
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Universitario de Getafe
Getafe, 28905
Hospital Universitari De Bellvitge
L'Hospitalet de Llobregat, Catalonia, 08907
Hospital Clinico San Carlos
Madrid, Madrid, Communidad de, 28040
Hospital Universitario La Paz
Madrid, Madrid, Communidad de, 28046
Hospital Universitario La Paz
Madrid, 28046
Hospital de Sabadell
Sabadell, Catalonia, 8208
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Catalonia, 43007
Hospital Mutua de Terrassa
Terrassa, Catalonia, 08221
Germany7 sites
Charité - Universitätsmedizin Berlin
Berlin, 13353
Universitätsklinikum Bonn
Bonn, 53105
Helios Klinikum Erfurt
Erfurt, 99089
Klinikum der Johann-Wolfgang Goethe-Universität
Frankfurt am Main, 60590
Klinikum der Friedrich-Schiller-Universität Jena
Jena, 07747
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, 67063
Klinikum Harlaching
München, 81545
Israel6 sites
Rambam Medical Center
Haifa, 31096
The Lady Davis Carmel Medical Center
Haifa, 34362
Shaare Zedek Medical Center
Jerusalem, 91031
Hadassah University Hospital Ein Kerem
Jerusalem, 91120
Western Galilee Hospital - Nahariya
Nahariya, 22100
Rabin Medical Center
Petah Tikva, 49100
Netherlands6 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ
VU Medisch Centrum
Amsterdam, 1081 HV
Gelre Ziekenhuizen
Apeldoorn, 7334 DZ
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
UMC St. Radboud
Nijmegen, 6525 GA
Ikazia Ziekenhuis
Rotterdam, 3083 AN
United Kingdom5 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
St James's University Hospital
Leeds, LS9 7TF
St John's Hospital
Livingston, EH54 6PP
University College London
London, NW1 2BU
St. Thomas' Hospital
London, SE1 7EH
Denmark2 sites
Aalborg Sygehus
Aalborg, DK-9100
Odense universitetshospital
Odense, DK-5000
About this study
Official title: OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.
- Conditions
- Severe Sepsis
- Being tested
- Talactoferrin alfa, Placebo
- Keywords
- sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talactoferrin alfaDrug
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
PlaceboDrug
15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Talactoferrin alfa | Experimental | Not described Receives: Drug: Talactoferrin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Measured: 28 Days
Secondary outcomes (4)
All Cause Mortality
Measured: 3 months
All Cause Mortality
Measured: 6 months
All Cause Mortality
Measured: 12 months
Assess Safety and Tolerability
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Data Safety Monitoring Board recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agennix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273779
- Sponsor's protocol ID
- LF-0802
- Acronym
- OASIS
- Status last verified
- Feb 2012
- First submitted
- 7 Jan 2011
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vincent JL, Marshall JC, Dellinger RP, Simonson SG, Guntupalli K, Levy MM, Singer M, Malik R; Oral tAlactoferrin in Severe sepsIS Study Investigators. Talactoferrin in Severe Sepsis: Results From the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med. 2015 Sep;43(9):1832-8. doi: 10.1097/CCM.0000000000001090.
PubMed 26010687
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT01273779
- Acronym / sponsor ID
- OASIS / LF-0802
- Conditions
- Severe Sepsis
- Keywords
- sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Data Safety Monitoring Board recommendation
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- AgennixIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Talactoferrin alfa | Experimental | Drug: Talactoferrin alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 or authorized representatives according to local rules or regulations
- Able to take liquid medication by mouth or feeding tube
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talactoferrin alfa15 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 | Drug | Talactoferrin alfa |
| Placebo15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit | Drug | Placebo |
Primary outcome
All Cause Mortality
Time frame: 28 Days
4 secondary outcomes
All Cause Mortality
Time frame: 3 months
All Cause Mortality
Time frame: 6 months
All Cause Mortality
Time frame: 12 months
Assess Safety and Tolerability
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Derived from this study: PubMed 26010687Vincent JL, Marshall JC, Dellinger RP, Simonson SG, Guntupalli K, Levy MM, Singer M, Malik R; Oral tAlactoferrin in Severe sepsIS Study Investigators. Talactoferrin in Severe Sepsis: Results From the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med. 2015 Sep;43(9):1832-8. doi: 10.1097/CCM.0000000000001090.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
100 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Talactoferrin alfa in people with Severe Sepsis, run by Agennix at 100 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, France, Belgium, Canada, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Cause Mortality (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01273779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.