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.
|Cystic Fibrosis Methicillin-resistant Staphylococcus Aureus||Drug: Rifampin Drug: Trimethoprim/Sulfamethoxazole Drug: Minocycline Drug: Mupirocin Drug: chlorhexidine gluconate oral rinse Drug: 2% Chlorhexidine solution wipes Behavioral: Environmental Decontamination||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Although this is an open-label study, the PIs and operational study team will remain blinded to the study arm assignments of the aggregate study population and will not view aggregate study results by study arm until after database lock.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)|
- MRSA Culture Status [ Time Frame: Day 28 ]Proportion of subjects with a negative culture for MRSA at Day 28.
- Antibiotic Use (Proportion of Subjects) [ Time Frame: 6 months ]Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.
- Antibiotic Use (Days of Use Per Subject) [ Time Frame: 6 months ]Days of use of oral, inhaled, and IV antibiotics over the 6 month study.
- Pulmonary Exacerbations [ Time Frame: 28 days ]Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.
|Actual Study Start Date:||April 2011|
|Study Completion Date:||May 2015|
|Primary Completion Date:||January 2015 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349192
|United States, Alabama|
|The Children's Hospital-University of Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, Colorado|
|The Children's Hospital|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611|
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109-5212|
|United States, Minnesota|
|Children's Hospitals and Clinics of Minnesota Minneapolis|
|Minneapolis, Minnesota, United States, 55404|
|United States, Missouri|
|St. Louis Children's Hospital|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|N.C Memorial Hospital and N.C Children's Hospital|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3026|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Cook Children's Medical Center|
|Fort Worth, Texas, United States, 76104|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle, Washington, United States, 98145-9807|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Marianne S Muhlebach, MD||UNC Children's Hospital|
|Principal Investigator:||Chris Goss, MD||University of Washington|