Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Description

Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics in hospitalized infants with suspected systemic infection or receiving one of the study drugs per local standard of care. Number of participants are 16-32 evaluable per each study drug of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics. ;

NCT number	NCT01728363
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	Phase 1
Start date	January 2013
Completion date	May 2015

Status	Clinical Trial	Phase
Enrolling by invitation	`NCT03064100` - Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel	N/A
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Recruiting	`NCT05841875` - Efficacy and Safety of a Protocol Using C-reactive Protein to Guide Antibiotic Therapy	N/A

Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio) — Staph

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms