Similarities and difference between STAR-ter and STAR-too protocols
| STAR-ter | STAR-too | |
| Study sites by region | West: 2 Midwest: 6 South: 1 North East: 0 | West: 2 Midwest: 6 South: 3 North East: 0 |
| Eligibility age | ≥2–≤45 years | ≥4–≤45 years |
| Drug cycle | 14-day oral antibiotic treatment cycle 14-day washout period Repeat treatment cycle# | 14-day oral antibiotic treatment cycle |
| Primary end-point | The proportion of subjects with MRSA eradicated from respiratory tract cultures at Day 28 compared to the placebo arm in STAR-too | The proportion of subjects with MRSA eradicated from respiratory tract cultures at Day 28 compared to the placebo arm |
| Inclusion | Incident or ≤2 positive MRSA cultures | Incident or ≤2 positive MRSA cultures |
| Exclusion | Receiving oral or i.v. anti-MRSA antibiotics within 28 days MRSA resistant to study drug Patient allergic to any of the study medications Abnormal renal of liver function or FEV1 <25% predicted Pregnancy, lactation or not using barrier contraception Post transplant (any solid organ) | Receiving oral or i.v. anti-MRSA antibiotics within 28 days MRSA resistant to study drug Patient allergic to any of the study medications Abnormal renal of liver function or FEV1 <25% predicted Pregnancy, lactation or not using barrier contraception Post transplant (any solid organ) |
Text in bold highlights differences between studies. MRSA: methicillin-resistant Staphylococcus aureus; FEV1: forced expiratory volume in 1 s. #: this repeat cycle occurs past the primary end-point thus no direct comparison to STAR-too placebo will be done.