Methicillin-resistant Staphylococcus aureus eradication in cystic fibrosis patients: A randomized multicenter study.


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2019
Historique:
received: 20 04 2018
accepted: 24 02 2019
entrez: 23 3 2019
pubmed: 23 3 2019
medline: 4 12 2019
Statut: epublish

Résumé

Few studies, based on a limited number of patients using non-uniform therapeutic protocols, have analyzed Methicillin-resistant Staphylococcus aureus (MRSA) eradication. In a randomized multicenter trial conducted on patients with new-onset MRSA infection we evaluated the efficacy of an early eradication treatment (arm A) compared with an observational group (B). Arm A received oral rifampicin and trimethoprim/sulfamethoxazole (21 days). Patients' microbiological status, FEV1, BMI, pulmonary exacerbations and use of antibiotics were assessed. Sixty-one patients were randomized. Twenty-nine (47.5%) patients were assigned to active arm A and 32 (52.5%) patients to observational arm B. Twenty-nine (47.5%) patients, 10 patients in arm A and 19 in arm B, dropped out of the study. At 6 months MRSA was eradicated in 12 (63.2%) out of 19 patients in arm A while spontaneous clearance was observed in 5 (38.5%) out of 13 patients in arm B. A per-protocol analysis showed a 24.7% difference in the proportion of MRSA clearance between the two groups (z = 1.37, P(Z>z) = 0.08). Twenty-seven patients, 15 (78.9%) out of 19 in arm A and 12 (92.3%) out of 13 in arm B, were able to perform spirometry. The mean (±SD) FEV1 change from baseline was 7.13% (±14.92) in arm A and -1.16% (±5.25) in arm B (p = 0.08). In the same period the BMI change (mean ±SD) from baseline was 0.54 (±1.33) kg/m2 in arm A and -0.38 (±1.56) kg/m2 in arm B (p = 0.08). At 6 months no statistically significant differences regarding the number of pulmonary exacerbations, days spent in hospital and use of antibiotics were observed between the two arms. Although the statistical power of the study is limited, we found a 24.7% higher clearance of MRSA in the active arm than in the observational arm at 6 months. Patients in the active arm A also had favorable FEV1 and BMI tendencies.

Sections du résumé

BACKGROUND
Few studies, based on a limited number of patients using non-uniform therapeutic protocols, have analyzed Methicillin-resistant Staphylococcus aureus (MRSA) eradication.
METHODS
In a randomized multicenter trial conducted on patients with new-onset MRSA infection we evaluated the efficacy of an early eradication treatment (arm A) compared with an observational group (B). Arm A received oral rifampicin and trimethoprim/sulfamethoxazole (21 days). Patients' microbiological status, FEV1, BMI, pulmonary exacerbations and use of antibiotics were assessed.
RESULTS
Sixty-one patients were randomized. Twenty-nine (47.5%) patients were assigned to active arm A and 32 (52.5%) patients to observational arm B. Twenty-nine (47.5%) patients, 10 patients in arm A and 19 in arm B, dropped out of the study. At 6 months MRSA was eradicated in 12 (63.2%) out of 19 patients in arm A while spontaneous clearance was observed in 5 (38.5%) out of 13 patients in arm B. A per-protocol analysis showed a 24.7% difference in the proportion of MRSA clearance between the two groups (z = 1.37, P(Z>z) = 0.08). Twenty-seven patients, 15 (78.9%) out of 19 in arm A and 12 (92.3%) out of 13 in arm B, were able to perform spirometry. The mean (±SD) FEV1 change from baseline was 7.13% (±14.92) in arm A and -1.16% (±5.25) in arm B (p = 0.08). In the same period the BMI change (mean ±SD) from baseline was 0.54 (±1.33) kg/m2 in arm A and -0.38 (±1.56) kg/m2 in arm B (p = 0.08). At 6 months no statistically significant differences regarding the number of pulmonary exacerbations, days spent in hospital and use of antibiotics were observed between the two arms.
CONCLUSIONS
Although the statistical power of the study is limited, we found a 24.7% higher clearance of MRSA in the active arm than in the observational arm at 6 months. Patients in the active arm A also had favorable FEV1 and BMI tendencies.

Identifiants

pubmed: 30901344
doi: 10.1371/journal.pone.0213497
pii: PONE-D-18-06443
pmc: PMC6430412
doi:

Substances chimiques

Anti-Bacterial Agents 0
Trimethoprim, Sulfamethoxazole Drug Combination 8064-90-2
Rifampin VJT6J7R4TR

Types de publication

Comparative Study Journal Article Multicenter Study Observational Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0213497

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

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Auteurs

Daniela Dolce (D)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.

Stella Neri (S)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.
Department of Health Sciences, University of Florence, Florence, Italy.

Laura Grisotto (L)

Department of Statistics, Computer Science and Applications "G. Parenti", University of Florence, Florence, Italy.

Silvia Campana (S)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.

Novella Ravenni (N)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.

Francesca Miselli (F)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.
Department of Health Sciences, University of Florence, Florence, Italy.

Erica Camera (E)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.

Lucia Zavataro (L)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.

Cesare Braggion (C)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.

Ersilia V Fiscarelli (EV)

Cystic Fibrosis Microbiology and Cystic Fibrosis Center, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy.

Vincenzina Lucidi (V)

Cystic Fibrosis Microbiology and Cystic Fibrosis Center, Children's Hospital and Research Institute Bambino Gesù, Rome, Italy.

Lisa Cariani (L)

Laboratory for Cystic Fibrosis Microbiology, Fondazione IRCCS, Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.

Daniela Girelli (D)

Laboratory for Cystic Fibrosis Microbiology, Fondazione IRCCS, Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.

Nadia Faelli (N)

Cystic Fibrosis Center, University of Milan, Fondazione IRCCS, Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.

Carla Colombo (C)

Cystic Fibrosis Center, University of Milan, Fondazione IRCCS, Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.

Cristina Lucanto (C)

Cystic Fibrosis and Pediatric Gastroenterology Unit, University of Messina, Messina, Italy.

Mariangela Lombardo (M)

Cystic Fibrosis and Pediatric Gastroenterology Unit, University of Messina, Messina, Italy.

Giuseppe Magazzù (G)

Cystic Fibrosis and Pediatric Gastroenterology Unit, University of Messina, Messina, Italy.

Antonella Tosco (A)

Department of Translational Medical Sciences, Pediatric Cystic Fibrosis Center, Federico II University, Naples, Italy.

Valeria Raia (V)

Department of Translational Medical Sciences, Pediatric Cystic Fibrosis Center, Federico II University, Naples, Italy.

Serena Manara (S)

Center for Integrative Biology, University of Trento, Trento, Italy.

Edoardo Pasolli (E)

Center for Integrative Biology, University of Trento, Trento, Italy.

Federica Armanini (F)

Center for Integrative Biology, University of Trento, Trento, Italy.

Nicola Segata (N)

Center for Integrative Biology, University of Trento, Trento, Italy.

Annibale Biggeri (A)

Department of Statistics, Computer Science and Applications "G. Parenti", University of Florence, Florence, Italy.

Giovanni Taccetti (G)

Cystic Fibrosis Center, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.

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