Neri 2016.
Methods | RCT (open‐label). Design: parallel. Location: multicentre (6 centres) in Italy. Duration: 21 days treatment with follow up to 6 months. |
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Participants | People with CF over 4 years of age with first or new MRSA infection, not infected by B cepacia complex and with no clinical signs of respiratory exacerbation and who could demonstrate regular visits to the centre. From 2013, 61 participants randomised: 29 to treatment arm and 32 to control arm. Mean age 19.1 (12.9) years. |
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Interventions |
Eradication protocol: an association of antibiotics according to susceptibility pattern (oral co‐trimoxazole and rifampicin for 21 days associated with intranasal mupirocin for 5 days). Control group: observation only. |
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Outcomes | Successful eradication or failure, where successful eradication is defined as the absence of MRSA following antibiotic treatment in at least 3 antibiograms over a period of 6 months. | |
Notes | Awaiting data analysis and full publication. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were "randomly" assigned to active treatment arm or observation only arm. However, the procedure for randomisation is unclear from the abstract. |
Allocation concealment (selection bias) | Unclear risk | Not discussed in abstract. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not discussed in abstract |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear from abstract data. |
Selective reporting (reporting bias) | Unclear risk | Original protocol not published. |
Other bias | Unclear risk | Unclear from abstract data |
B cepacia: Burkholderia cepacia CF: cystic fibrosis IV: intravenous MRSA: meticillin‐resistant Staphyloccocus aureus RCT: randomised controlled trial TMP‐SMX: trimethoprim‐sulfamethoxazole