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)
- Principal Investigator: Michael J. Beck
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.
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.
Penn State Milton S. Hershey Medical Center
Pediatric Clinical Research Office