Clinical trial NCT01349192
Conditions: Cystic Fibrosis Methicillin-resistant Staphylococcus Aureus
Keywords: MRSA Cystic Fibrosis Early Infection Treatment
Sponsor: University of North Carolina, Chapel Hill
Start date: 2011-04-01; Completion date: 2015-05-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
The STAR-too study is a randomized, open label, multi-center study in CF patients with new MRSA isolated from the respiratory tract (sputum or oropharyngeal (OP) swab). The purpose of the study is to compare use of a two week eradication treatment protocol to an observational group treated for MRSA only when respiratory symptoms meet the criteria for a protocol defined pulmonary exacerbation during the first 28 days of the study. A total of 90 participants, four years of age or older, with new MRSA infection are planned to be randomized in a 1:1 fashion to either the treatment arm or to the observational control arm. Randomization is stratified by age, P. aeruginosa status at screening and site. Each participant randomized to the treatment arm receives two oral antibiotics for 14 days, topical antibacterial treatment of skin and nares, and a three week environmental decontamination for high risk areas and equipment. Each participant randomized to the observational control arm is followed clinically with usual care except to treat new or worsening pulmonary symptoms with antibiotics between screening and Day 28 only when participant meets criteria for a protocol defined exacerbation. Participants continue in the study for 6 months with study visits at Day 84 and Day 168 corresponding with their normal quarterly visits, this extension of observation provides additional data regarding natural history of MRSA infection and durability of the eradication protocol. The primary outcome is the proportion of participants with MRSA eradicated from respiratory tract cultures at Day 28. The secondary outcomes number of, and time to, pulmonary exacerbations, and use of antibiotics.

Arms: arm 1: Subjects are treated with two oral antibiotics, topical antibiotics, and are instructed to use environmental decontamination techniques. arm 2: 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.
Interventions: intervention 1: Rifampin intervention 2: Trimethoprim/Sulfamethoxazole intervention 3: Minocycline intervention 4: Mupirocin intervention 5: chlorhexidine gluconate oral rinse intervention 6: 2% Chlorhexidine solution wipes intervention 7: Environmental Decontamination
Intervention descriptions: intervention 1: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \<40kg : 15mg/kg daily for 14 days divided every 12 hours. intervention 2: 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. intervention 3: 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. intervention 4: 1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 14 days. intervention 5: for subjects able to swish without swallowing. 0.12% chlorhexidine gluconate oral rinse twice daily for 14 days. intervention 6: whole body wash solution wipes once daily for first 5 days. intervention 7: 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.

Protocol documents: