Gram Positive InfectionPhase 1NCT00679835
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
A Phase 1 study testing daptomycin in people with Gram Positive Infection and Concurrent Antibiotic Treatment, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria). Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Gram Positive Infection, Concurrent Antibiotic Treatment
- What is being tested?
- daptomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2008to 20 Nov 2008
- Phase
- Phase 1
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care;
- Male or female between the ages of 2 and 6 years old, inclusive;
- Able to comply with the protocol for the duration of the study;
- Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise;
- Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy;
- A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline;
- Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline.
- Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1.
Who cannot join
- Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
- Known allergy/ hypersensitivity to daptomycin;
- History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
- Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
- Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator;
- Administration of rifampin within 7 days of study drug administration;
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- Body mass index (BMI) that is outside of the 5th to 95th percentile;
- Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);
- History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
- Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing;
- Expected surgical procedure(s) within 24 hours prior to and following dosing;
- Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or spinal cord injury;
- History of or current rhabdomyolysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).
- Being tested
- daptomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daptomycinDrug
Also called Cubicin
i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 8 mg/kg over a one hour infusion Receives: Drug: daptomycin |
| Group 2 | Experimental | 10mg/kg over a one or two hour infusion Receives: Drug: daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmocokinetics of daptomycin
Measured: From pre-dose to 24 hours post-dose
Secondary outcomes (1)
Safety of daptomycin
Measured: Up to 9 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study start3 Jun 2008
- Primary completion20 Nov 2008
- Study completion20 Nov 2008
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 Gram Positive InfectionStudies 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679835
- Sponsor's protocol ID
- 3009-023
- Other IDs
- DAP-PEDS-07-02
- Status last verified
- Nov 2019
- First submitted
- 15 May 2008
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Abdel-Rahman SM, Chandorkar G, Akins RL, Bradley JS, Jacobs RF, Donovan J, Benziger DP. Single-dose pharmacokinetics and tolerability of daptomycin 8 to 10 mg/kg in children aged 2 to 6 years with suspected or proved Gram-positive infections. Pediatr Infect Dis J. 2011 Aug;30(8):712-4. doi: 10.1097/INF.0b013e31820fc8e1.
PubMed 21317681
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection
- ClinicalTrials.gov ID
- NCT00679835
- Acronym / sponsor ID
- 3009-023
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2008 (actual)
- Primary completion
- 20 Nov 2008 (actual)
- Study completion
- 20 Nov 2008 (actual)
- First posted
- 19 May 2008 (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 is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: daptomycin8 mg/kg over a one hour infusion |
| Group 2 | Experimental | Drug: daptomycin10mg/kg over a one or two hour infusion |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care;
- Male or female between the ages of 2 and 6 years old, inclusive;
- Able to comply with the protocol for the duration of the study;
- Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise;
- Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy;
Key exclusion criteria (13 listed)
- Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
- Known allergy/ hypersensitivity to daptomycin;
- History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
- Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
- Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator;
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 |
|---|---|---|
| daptomycinAlso: Cubicini.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion. | Drug | Group 1, Group 2 |
Primary outcome
Pharmocokinetics of daptomycin
Time frame: From pre-dose to 24 hours post-dose
1 secondary outcome
Safety of daptomycin
Time frame: Up to 9 days after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Results publication: PubMed 21317681Abdel-Rahman SM, Chandorkar G, Akins RL, Bradley JS, Jacobs RF, Donovan J, Benziger DP. Single-dose pharmacokinetics and tolerability of daptomycin 8 to 10 mg/kg in children aged 2 to 6 years with suspected or proved Gram-positive infections. Pediatr Infect Dis J. 2011 Aug;30(8):712-4. doi: 10.1097/INF.0b013e31820fc8e1.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
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 Gram Positive Infection and Concurrent Antibiotic Treatment, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) 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 8 inclusion and 13 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 13 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmocokinetics of daptomycin (time frame: From pre-dose to 24 hours post-dose). 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 NCT00679835, 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 13 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.