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Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic
Mark T Jennings1, Michael P Boyle, David Weaver
1Johns Hopkins Medical Institutions, 1830 E, Monument Street, 5th floor, Baltimore, Maryland 21205, USA. mjenni15@jhmi.edu.
Background:
The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) respiratory infection in cystic fibrosis (CF) has increased dramatically over the last decade, and is now affecting approximately 25% of patients. Epidemiologic evidence suggests that persistent infection with MRSA results in an increased rate of decline in FEV1 and shortened survival. Currently, there are no conclusive studies demonstrating an effective and safe treatment protocol for persistent MRSA respiratory infection in CF.
Methods/Design:
The primary objective of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation in combination with oral antibiotics in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. This is a two-center, randomized, double-blind, comparator-controlled, parallel-group study with 1:1 assignment to either vancomycin for inhalation (250 mg twice a day) or taste-matched placebo for 28 days in individuals with cystic fibrosis. In addition, both groups will receive oral rifampin, a second oral antibiotic - trimethoprim/sulfamethoxazole (TMP/SMX) or doxycycline, protocol determined - mupirocin intranasal cream, and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled: 20 will be randomized to vancomycin for inhalation and 20 to a taste-matched placebo. The primary outcome will be the presence of MRSA in sputum respiratory tract cultures 1 month after the conclusion of treatment. Secondary outcomes include the efficacy of the intervention on: FEV1% predicted, patient reported outcomes, pulmonary exacerbations, and MRSA colony-forming units found in respiratory tract sample culture.
Discussion:
Results of this study will provide guidance to clinicians regarding the safety and effectiveness of a targeted eradication strategy for persistent MRSA infection in CF.
Trial Registration:
This trial is registered at ClinicalTrials.gov (NCT01594827, received 05/07/2012) and is funded by the Cystic Fibrosis Foundation (Grants: PMEP10K1 and PMEP11K1).
Insights
This study investigates inhaled vancomycin for cystic fibrosis patients with MRSA respiratory infections. Results will guide clinicians on this targeted treatment strategy.
Area of Science:
- Pulmonary Medicine
- Infectious Diseases
- Pharmacology
Background:
- Methicillin-resistant Staphylococcus aureus (MRSA) respiratory infections are increasingly prevalent in cystic fibrosis (CF) patients, affecting approximately 25%.
- Persistent MRSA infection is linked to accelerated lung function decline (FEV1) and reduced survival in CF.
- No definitive treatment protocols exist for persistent MRSA respiratory infections in CF.
Purpose of the Study:
- To evaluate the safety and efficacy of inhaled vancomycin combined with oral antibiotics for MRSA eradication in CF patients.
- To assess the impact of this treatment on respiratory tract MRSA clearance and clinical outcomes.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 40 CF patients with persistent MRSA respiratory infection.
- Participants received either 28 days of inhaled vancomycin or placebo, alongside oral antibiotics, intranasal mupirocin, and body washes.
- Primary outcome: MRSA presence in sputum cultures one month post-treatment. Secondary outcomes: FEV1, patient-reported outcomes, and pulmonary exacerbations.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- Study results will inform clinical practice regarding the safety and effectiveness of inhaled vancomycin for MRSA eradication in CF patients.
- Findings will contribute to developing targeted treatment strategies for persistent MRSA infections in this population.
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