Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF) (STAR-Too)
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.
Methicillin-resistant Staphylococcus Aureus
Drug: chlorhexidine gluconate oral rinse
Drug: 2% Chlorhexidine solution wipes
Behavioral: Environmental Decontamination
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)|
- Microbiology [ Time Frame: Day 28 ] [ Designated as safety issue: No ]Proportion of subjects in each arm with MRSA negative respiratory cultures at day 28.
- Antibiotic Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study and number of days of use.
- Exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]Proportion of subjects with a protocol defined pulmonary exacerbation between baseline and day 28 who are treated with antibiotics active against MRSA.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Subjects are treated with two oral antibiotics, topical antibiotics, and are instructed to use environmental decontamination techniques.
Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Other Name: Rifadin, RimactaneDrug: 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.
Other Name: Bactrim, SeptraDrug: 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.
Other Name: Cleeravue-M, Dynacin, Minocin, Myrac, Solodyn, VectrinDrug: Mupirocin
1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 14 days.
Other Name: Bactroban, CentanyDrug: 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.
Other Name: Sani-Cloth Plus
No Intervention: Observational
Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
|Contact: Jill Van Dalfsenfirstname.lastname@example.org|
|Contact: Marianne S Muhlebach, MD||919-966-1055||Marianne_Muhlebach@med.unc.edu|
|United States, Alabama|
|The Children's Hospital-University of Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Ginger Reeves 205-939-5970 email@example.com|
|Principal Investigator: Wynton Hoover|
|United States, Colorado|
|The Children's Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Meg Anthony 720-777-2945 firstname.lastname@example.org|
|Principal Investigator: Edith Zemanick|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Dawn Baker, RN 352-273-5417 email@example.com|
|Principal Investigator: Pamela Schuler, MD|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48109-5212|
|Contact: Marisa Linn 734-615-1372 firstname.lastname@example.org|
|Principal Investigator: Amy Filbrun|
|United States, Minnesota|
|Children's Hospitals and Clinics of Minnesota Minneapolis||Recruiting|
|Minneapolis, Minnesota, United States, 55404|
|Contact: Andrea Gruber, RN 612-813-6661 email@example.com|
|Principal Investigator: John McNamara, MD|
|United States, Missouri|
|St. Louis Children's Hospital||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Mary Boyle 314-454-4609 firstname.lastname@example.org|
|Principal Investigator: Peter Michelson|
|United States, North Carolina|
|N.C Memorial Hospital and N.C Children's Hospital||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Kelly Stephenson 919-966-1055 Kelly_Stephenson@med.unc.edu|
|Contact: Marianne S Muhlebach, MD 919 966 1055 Marianne_Muhlebach@med.unc.edu|
|Principal Investigator: Marianne S Muhlebach, MD|
|United States, Ohio|
|CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229-3026|
|Contact: Duan Lorrie 513-636-7089 email@example.com|
|Principal Investigator: John P Clancy, MD|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Carolyne Cannon, MD 214-648-8709|
|Principal Investigator: Carolyn Cannon, MD|
|Cook Children's Medical Center||Recruiting|
|Fort Worth, Texas, United States, 76104|
|Contact: Sara Scott 682-885-1244 Sara.Scott@CookChildrens.org|
|Principal Investigator: James Cunningham|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Charlene Hallmark 832-822-4772 firstname.lastname@example.org|
|Principal Investigator: Siby Moonumakal|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Alycia Wolfstone 206-685-3995 email@example.com|
|Principal Investigator: Christopher Goss, MD|
|Seattle, Washington, United States, 98145-9807|
|Contact: Sharon McNamara 206-987-3921 ext 1 firstname.lastname@example.org|
|Principal Investigator: Ronald Gibson|
|Principal Investigator:||Marianne S Muhlebach, MD||UNC Children's Hospital|
|Principal Investigator:||Chris Goss, MD||University of Washington|