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Antibiotic-Resistant Bacterial infections in Babies - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if a single dose of an antibiotic called dalbavancin is safe and effective to treat infections in children.
What is the Condition Being Studied?
Antibiotic-Resistant Bacterial infections in babies

Who Can Participate in the Study?

To be in this study, your child must:
- Be a preterm baby (32-37 weeks gestation)
- Be term baby (more than 37 weeks gestation) to 28 days old
- Be a young infant (age 28 days to 3 months old)
- Be getting an antibiotic for a bacterial infection for at least 24 hours

Age Group

What is Involved?

If you decide that you would like for your child to be in this study, your child:
- Will be part of this study for about 28 to 35 days
- Will receive a study medicine called Dalbavancin
- Have a physical exam, vital signs, and hearing test
- Will give blood samples

Study Details

Full Title
Pharmacokinetics of a Single-Dose of Dalbavancin in Preterm Neonates to Infants Ages 3 Months with Suspected or Confirmed Bacterial Infection
Principal Investigator
Protocol Number
IRB: PRO00069483
NCT: NCT02688790
Phase I
Contact the Duke Recruitment Innovation Center