SepsisPhase 1NCT00942149

An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

A Phase 1 study testing Daptomycin in people with Sepsis, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 48 hours to 120 days
Conditions the study is for: Sepsis
What is being tested?: Daptomycin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Dec 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 48 hours to 120 days
All sexes
No healthy volunteers
Child

Who may be able to join

> 48 hours and <120 days of age at the time of daptomycin administration
Sufficient venous access to permit administration of study medication
Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
Availability and willingness of the parent/legally authorized representative to provide written informed consent

Who cannot join

History of anaphylaxis attributed to daptomycin
Previous participation in the study
Exposure to daptomycin in the month prior to the study
Serum creatinine >1.0 mg/dL
Concomitant administration of tobramycin

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

This is a safety and pharmacokinetic study of single-dose daptomycin in infants > 48 hours and < 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC <740 mch*hr/mL.

Conditions: Sepsis
Being tested: Daptomycin
Keywords: Infants, Daptomycin
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaptomycinDrug
single dose of 6 mg/kg of daptomycin

Study groups in NCT00942149
Study group	Role	What they receive
Daptomycin cohort	Experimental	Not described Receives: Drug: Daptomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

PK of Daptomycin
Area under the curve
Measured: 24 hours

Secondary outcomes (1)

Adverse Events Will be Monitored.
Measured: 7 days following last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Dec 2011

First posted20 Jul 2009 (estimated)
Study startJan 2010
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00942149
Sponsor's protocol ID: Pro00019311
Other IDs: dapto1
Status last verified: Jun 2013
First submitted: 2 Jul 2009
Last updated: 15 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
ClinicalTrials.gov ID: NCT00942149
Acronym / sponsor ID: Pro00019311
Conditions: Sepsis
Keywords: Infants, Daptomycin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Jan 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 20 Jul 2009 (estimated)
Results: Posted 12 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Daptomycin cohort	Experimental	Drug: Daptomycin

Who may qualify

Ages: 48 hours to 120 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

> 48 hours and <120 days of age at the time of daptomycin administration
Sufficient venous access to permit administration of study medication
Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
Availability and willingness of the parent/legally authorized representative to provide written informed consent

Key exclusion criteria (5 listed)

History of anaphylaxis attributed to daptomycin
Previous participation in the study
Exposure to daptomycin in the month prior to the study
Serum creatinine >1.0 mg/dL
Concomitant administration of tobramycin

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
Daptomycinsingle dose of 6 mg/kg of daptomycin	Drug	Daptomycin cohort

Primary outcome

PK of Daptomycin
Time frame: 24 hours
Area under the curve

1 secondary outcome

Adverse Events Will be Monitored.
Time frame: 7 days following last dose of study drug

Results and safety

Results posted to the registry on 12 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daptomycin Cohort	20	20

Primary outcome: PK of Daptomycin

Time frame: 24 hours. Median (Full Range). Unit: mg*h/L

Measure	Area Under the Curve - 24 Hours n = 20
Value	262.4 (.005)

Population analysed: all 20 subjects were analyzed

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daptomycin Cohort	3 of 20 (15%)	6 of 20 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

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.

P Brian Smith, MD MHS principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Daptomycin in people with Sepsis, run by Duke University at 1 site 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 5 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: finished, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

PK of Daptomycin (time frame: 24 hours). 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 NCT00942149.

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 Jul 2013.