Nosocomial InfectionsPhase 1/2NCT00854633
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
A Phase 1/2 study testing Talactoferrin in people with Nosocomial Infections, run by Agennix at 4 sites in United States.
Trial summary
This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants. Read more about this study
- Who is it for?
- Ages 1 minute to 24 hours
- Conditions the study is for
- Nosocomial Infections
- What is being tested?
- Talactoferrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2009to Dec 2012
- Phase
- Phase 1/2
- 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 1 minute to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weights ranging from 750 to 1500 grams
- Entry before 24 hours of age
- Informed-consent form signed by parent(s) or legal guardian
- Able to take liquid medication by mouth or feeding tube
Who cannot join
- A major birth defect or malformation syndrome
- Chromosomal or inherited disorder
- Proven presence of an immunodeficiency
- Antenatal exposure to illicit substances
- Birth asphyxia
- HIV or other congenital viral, bacterial, or fungal infection
Show all 9Show fewer
- Lack of parental consent or refusal of attending neonatologist to allow participation
- Discretion of the investigator
- The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
University of Missouri Health Care, Columbia Regional Hospital
Columbia, Missouri, 65201
- Recruiting
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
- Recruiting
Kosair Children's Hospital
Louisville, Kentucky, 40202
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.
- Conditions
- Nosocomial Infections
- Being tested
- Talactoferrin, Placebo
- Keywords
- Pre-term infants, Pre-term infants 750 to 1500 grams
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalactoferrinDrug
Also called talactoferrin alfa, TLF, recombinant human lactoferrin, rhLF
Enteral, 150 mg/kg twice per day
PlaceboDrug
Oral, twice per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Talactoferrin Receives: Drug: Talactoferrin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)
Measured: 1-3 months
Secondary outcomes (3)
"NEC Scares", the "Neonatal Sepsis Syndrome"
Measured: 1-3 months
Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU
Measured: 1-3 months
Mortality during hospitalization
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nosocomial InfectionsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agennix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854633
- Sponsor's protocol ID
- LF-0901
- Other IDs
- 1R44HD057744-01A1
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2009
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sherman MP, Adamkin DH, Niklas V, Radmacher P, Sherman J, Wertheimer F, Petrak K. Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants. J Pediatr. 2016 Aug;175:68-73.e3. doi: 10.1016/j.jpeds.2016.04.084. Epub 2016 May 31.
PubMed 27260839Sherman MP, Sherman J, Arcinue R, Niklas V. Randomized Control Trial of Human Recombinant Lactoferrin: A Substudy Reveals Effects on the Fecal Microbiome of Very Low Birth Weight Infants. J Pediatr. 2016 Jun;173 Suppl:S37-42. doi: 10.1016/j.jpeds.2016.02.074.
PubMed 27234409
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
- ClinicalTrials.gov ID
- NCT00854633
- Acronym / sponsor ID
- LF-0901
- Conditions
- Nosocomial Infections
- Keywords
- Pre-term infants, Pre-term infants 750 to 1500 grams
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AgennixIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Mar 2009 (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.
This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TalactoferrinTalactoferrin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weights ranging from 750 to 1500 grams
- Entry before 24 hours of age
- Informed-consent form signed by parent(s) or legal guardian
- Able to take liquid medication by mouth or feeding tube
Key exclusion criteria (9 listed)
- A major birth defect or malformation syndrome
- Chromosomal or inherited disorder
- Proven presence of an immunodeficiency
- Antenatal exposure to illicit substances
- Birth asphyxia
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 |
|---|---|---|
| TalactoferrinAlso: talactoferrin alfa, TLF, recombinant human lactoferrin, rhLFEnteral, 150 mg/kg twice per day | Drug | 1 |
| PlaceboOral, twice per day | Drug | 2 |
Primary outcome
Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)
Time frame: 1-3 months
3 secondary outcomes
"NEC Scares", the "Neonatal Sepsis Syndrome"
Time frame: 1-3 months
Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU
Time frame: 1-3 months
Mortality during hospitalization
Time frame: 1-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
- Derived from this study: PubMed 27260839Sherman MP, Adamkin DH, Niklas V, Radmacher P, Sherman J, Wertheimer F, Petrak K. Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants. J Pediatr. 2016 Aug;175:68-73.e3. doi: 10.1016/j.jpeds.2016.04.084. Epub 2016 May 31.
- Derived from this study: PubMed 27234409Sherman MP, Sherman J, Arcinue R, Niklas V. Randomized Control Trial of Human Recombinant Lactoferrin: A Substudy Reveals Effects on the Fecal Microbiome of Very Low Birth Weight Infants. J Pediatr. 2016 Jun;173 Suppl:S37-42. doi: 10.1016/j.jpeds.2016.02.074.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Talactoferrin in people with Nosocomial Infections, run by Agennix at 4 sites in United States.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Rajesh Malik, MD (713-552-1091, rmalik@agennix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP) (time frame: 1-3 months). 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 NCT00854633, which also lists 2 linked publications.
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 15 Mar 2012.