STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

April 3, 2018

Primary Completion Date

August 30, 2025

Study Completion Date

December 30, 2025

Conditions
Cystic Fibrosis
Interventions
DRUG

Trimethoprim Sulfamethoxazole (TMP/SMX)

"Dosing if \< 40 kg: 8 mg/kg trimethoprim/40 mg/kg trimethoprim sulfamethoxazole given twice daily for 14 days during Days 1-14 and Days 29-42.~Dosing is ≥ 40 kg: 320 mg/1600 mg twice daily for 14 days during Days 1-14 and Days 29-42."

DRUG

Minocycline

"If a subject has an allergy to or intolerance to TMP/SMX, they may be treated with minocycline provided they are 8 years of age or older.~Dosing if \< 50 kg: 2 mg/kg orally twice daily for 14 days during Days 1-14 and Days 29-42.~Dosing if ≥ 50 kg: 100 mg twice daily for 14 days during Days 1-14 and Days 29-42."

DRUG

Mupirocin

1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 5 days during Days 1-5 and Days 29-33.

DRUG

Chlorhexidine Gluconate

For subjects able to swish without swallowing, 0.12% chlorhexidine gluconate oral rinse will be used twice daily for 14 days during Days 1-14 and Days 29-42.

BEHAVIORAL

Environmental Decontamination

"Subjects will be instructed to wipe down all high touch surfaces and medical equipment with surface disinfection wipes daily during Days 1-21 and Days 29-49.~Subjects will also be instructed to wash all linens and towels in hot water once weekly during weeks 1-3 and weeks 5-7."

Trial Locations (9)

27599

N.C. Memorial Hospital and N.C. Children's Hospital, Chapel Hill

46202

Indiana University, Indianapolis

48109

University of Michigan Health System, Ann Arbor

63110

St. Louis Children's Hospital, St Louis

75390

University of Texas Southwestern Medical Center, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Hospital, Baylor College of Medicine, Houston

80206

National Jewish Health, Denver

98195

University of Washington Medical Center and Seattle Children's, Seattle

All Listed Sponsors
collaborator

University of Washington

OTHER

collaborator

Cook Children's Medical Center

OTHER

collaborator

Indiana University

OTHER

collaborator

University of Michigan

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

St. Louis Children's Hospital

OTHER

lead

University of North Carolina, Chapel Hill

OTHER