Microbiological efficacy of early MRSA treatment in cystic fibrosis in a randomised controlled trial
Marianne Sponer Muhlebach, Valeria Beckett, Elena Popowitch, Melissa B Miller, Arthur Baines, Nicole Mayer-Hamblett, Edith T Zemanick, Wynton C Hoover, Jill M VanDalfsen, Preston Campbell, Christopher H Goss, STAR-too study team, Debbie Ng, John McNamara, Mahrya Johnson, Silby Moonnumakal, Nicoline Schaap, Meg Anthony, John P Clancy, Ronald Gibson, Sharon McNamara, Peter Michelson, Tina Hicks, Preeti Sharma, Andrew Hebert, Katie Brand, Pamela Schuler, Dawn Baker, Amy Filbrun, Marisa Linn, Paul Sammut, Raquel Telfer, Kelly Moormann, Karen Schultz, Heather Urbanek, Margaret Guill, John J LiPuma, Marci Sontag, Susan Murray, Miriam Hunt, Dianne L Howe, Jasna Hocevar-Trnka, Rose Mitchell, Lynette Browne, Marianne Sponer Muhlebach, Valeria Beckett, Elena Popowitch, Melissa B Miller, Arthur Baines, Nicole Mayer-Hamblett, Edith T Zemanick, Wynton C Hoover, Jill M VanDalfsen, Preston Campbell, Christopher H Goss, STAR-too study team, Debbie Ng, John McNamara, Mahrya Johnson, Silby Moonnumakal, Nicoline Schaap, Meg Anthony, John P Clancy, Ronald Gibson, Sharon McNamara, Peter Michelson, Tina Hicks, Preeti Sharma, Andrew Hebert, Katie Brand, Pamela Schuler, Dawn Baker, Amy Filbrun, Marisa Linn, Paul Sammut, Raquel Telfer, Kelly Moormann, Karen Schultz, Heather Urbanek, Margaret Guill, John J LiPuma, Marci Sontag, Susan Murray, Miriam Hunt, Dianne L Howe, Jasna Hocevar-Trnka, Rose Mitchell, Lynette Browne
Abstract
Objective: To evaluate microbiological effectiveness, that is, culture negativity of a non-blinded eradication protocol (Rx) compared with observation (Obs) in clinically stable cystic fibrosis participants with newly positive methicillin resistant Staphylococcusaureus (MRSA) cultures.
Design: This non-blinded trial randomised participants ages 4-45 years with first or early (≤2 positive cultures within 3 years) MRSA-positive culture without MRSA-active antibiotics within 4 weeks 1:1 to Rx or Obs. The Rx protocol was: oral trimethoprim-sulfamethoxazole or if sulfa-allergic, minocycline plus oral rifampin; chlorhexidine mouthwash for 2 weeks; nasal mupirocin and chlorhexidine body wipes for 5 days and environmental decontamination for 21 days. The primary end point was MRSA culture status at day 28.
Results: Between 1 April 2011 to September 2014, 45 participants (44% female, mean age 11.5 years) were randomised (24 Rx, 21 Obs). At day 28, 82% (n=18/22) of participants in the Rx arm compared with 26% (n=5/19) in the Obs arm were MRSA-negative. Adjusted for interim monitoring, this difference was 52% (95% CI 23% to 80%, p<0.001). Limiting analyses to participants who were MRSA-positive at the screening visit, 67% (8/12) in the Rx arm and 13% (2/15) in the Obs arm were MRSA-negative at day 28, adjusted difference: 49% (95% CI 22% to 71%, p<0.001). Fifty-four per cent in the Rx arm compared with 10% participants in the Obs arm remained MRSA-negative through day 84. Mild gastrointestinal side effects were higher in the Rx arm.
Conclusions: This MRSA eradication protocol for newly acquired MRSA demonstrated microbiological efficacy with a large treatment effect.
Trial registration number: NCT01349192.
Keywords: Bacterial Infection; Cystic Fibrosis; Infection Control.
Conflict of interest statement
Competing Interests: None declared.
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Source: PubMed