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

Daniela Dolce, Stella Neri, Laura Grisotto, Silvia Campana, Novella Ravenni, Francesca Miselli, Erica Camera, Lucia Zavataro, Cesare Braggion, Ersilia V Fiscarelli, Vincenzina Lucidi, Lisa Cariani, Daniela Girelli, Nadia Faelli, Carla Colombo, Cristina Lucanto, Mariangela Lombardo, Giuseppe Magazzù, Antonella Tosco, Valeria Raia, Serena Manara, Edoardo Pasolli, Federica Armanini, Nicola Segata, Annibale Biggeri, Giovanni Taccetti, Daniela Dolce, Stella Neri, Laura Grisotto, Silvia Campana, Novella Ravenni, Francesca Miselli, Erica Camera, Lucia Zavataro, Cesare Braggion, Ersilia V Fiscarelli, Vincenzina Lucidi, Lisa Cariani, Daniela Girelli, Nadia Faelli, Carla Colombo, Cristina Lucanto, Mariangela Lombardo, Giuseppe Magazzù, Antonella Tosco, Valeria Raia, Serena Manara, Edoardo Pasolli, Federica Armanini, Nicola Segata, Annibale Biggeri, Giovanni Taccetti

Abstract

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.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Trial profile.
Fig 1. Trial profile.

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