Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)

Summary

Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA.

Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit.

Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.

Conditions

• Cystic Fibrosis
• Methicillin-resistant Staphylococcus Aureus

Interventions

DRUG

Rifampin

Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \<40kg : 15mg/kg daily for 14 days divided every 12 hours.

DRUG

Trimethoprim/Sulfamethoxazole

Adult Dose: 320/1600 orally twice daily for 14 days. Pediatric Dose: \<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.

DRUG

Minocycline

only subjects greater or equal to 8 years of age, who are not able to tolerate TMP/SMX or whose screening MRSA is resistant to TMP/SMX should be prescribed minocycline. Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: \< 50 kg : 2mg/kg orally twice daily for 14 days not to exceed 200mg per day.

DRUG

Mupirocin

1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 14 days.

DRUG

chlorhexidine gluconate oral rinse

for subjects able to swish without swallowing. 0.12% chlorhexidine gluconate oral rinse twice daily for 14 days.

DRUG

2% Chlorhexidine solution wipes

whole body wash solution wipes once daily for first 5 days.

BEHAVIORAL

Environmental Decontamination

wipe down high touch surfaces and medical equipment with surface disinfecting wipes daily for the first 21 days. wash all linens and towels in hot water once weekly for three weeks.

Sponsors & Collaborators

• CF Therapeutics Development Network Coordinating Center

  collaborator NETWORK

• Seattle Children's Hospital

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Cook Children's Medical Center

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Florida

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• St. Louis Children's Hospital

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Marianne S Muhlebach, MD · UNC Children's Hospital

• Chris Goss, MD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2015-01-31

Completion

2015-05-31

Countries

• United States

Study Locations