Acute Care

A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics (PK) and Safety of Solithromycin as Add-on Therapy in Adolescents with Suspected or Confirmed Bacterial Infection (IRB# 44262)

Status: Active

 

Investigators:

  • Principal Investigator: Michael J. Beck

 

Description:

This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics (PK) and safety of solithromycin as add-on therapy in adolescents with suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.  The PK of solithromycin has not been evaluated in adolescents; therefore, a multiple-dose study will allow for characterization of drug exposures likely to be observed in adolescents receiving the drug in the clinical setting.         

 

 

Eligibility:

Inclusion criteria:
1. male or female 12-17 years of age.
2. Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active. 

 

Additional Study Details:

Potential subjects will be identified by doctor or nurse referral while the participant is in the hospital.

 

Locations:

Penn State Milton S. Hershey Medical Center

 

Contacts:

Pediatric Clinical Research Office

717-531-5656

 

Categories:

  • Acute Care