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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Doripenem in Infants Less Than 12 Weeks of Age

NCT01381848

Bacterial Infections

COMPLETED PHASE1

Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics

NCT00136292

Gram-positive Bacterial Infections

COMPLETED PHASE1

An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates

NCT00850122

Sepsis Prematurity

COMPLETED PHASE1

Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics

NCT01019395

Gram Positive Bacterial Infection

COMPLETED PHASE1

Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

NCT00873327

Sepsis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Daptomycin cohort

Group Type EXPERIMENTAL

Daptomycin

Intervention Type DRUG

single dose of 6 mg/kg of daptomycin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Daptomycin

single dose of 6 mg/kg of daptomycin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. \> 48 hours and \<120 days of age at the time of daptomycin administration
2. Sufficient venous access to permit administration of study medication
3. Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
4. Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria

1. History of anaphylaxis attributed to daptomycin
2. Previous participation in the study
3. Exposure to daptomycin in the month prior to the study
4. Serum creatinine \>1.0 mg/dL
5. Concomitant administration of tobramycin

Minimum Eligible Age

48 Hours

Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No