NCT01728363

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

Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Phillip Brian Smith · Academic / Other
• Sex: All
• Age: 14 Days – 32 Weeks
• Healthy volunteers: Not accepted

Summary

Multiple center, open-label, PK study

Detailed 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.

Conditions

• Systemic Infection

Interventions

Type	Name	Description
DRUG	Antibiotic	Ticarcillin-clavulanate/Timentin is an antibiotic used to treat a wide variety of bacterial infections. Rifampin/Rifadin/Rimatane is an antibiotic and first line antituberculotic. Clindamycin/Cleocin is an antibiotic used to treat a wide variety of bacterial infections and serious bacterial infections.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-11-19
• Last updated: 2023-07-27

Locations

10 sites across 1 country: United States