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

Summary

To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.

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.

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• Cook Children's Medical Center

  collaborator OTHER

• Indiana University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• St. Louis Children's Hospital

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Marianne Muhlebach, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-03

Primary Completion

2025-09-30

Completion

2026-01-31

FDA Drug

Yes

Countries

• United States

Study Locations