Beshey 2014.
Methods | Monocentre, randomized, parallel‐group (three groups) study Duration of the study: not reported Patients excluded/patients randomized: 0/75 (0%) Sample size calculation/method description: Yes/Yes |
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Participants |
Patients randomized: 75 Age (mean): 51.9 years (SDD), 48.9 years (SDD + fluconazole), 50.9 years (no intervention) Sex: 40 men, 35 women Inclusion criteria: mechanical ventilation > 48 hours and expected further 72 hours. Exclusion criteria: pregnancy, receipt of antifungal agents within seven days before ICU admission, age younger than 18 years, an expectation that the patient would not survive more than 24 hours, and patients who did not complete the 15 day period of the study either due to discharge from ICU or death Percentage post‐surgical: not reported Percentage colonized with Candida at baseline: not reported |
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Interventions |
1. SDD: oral decontamination with chlorhexidine to the mouth and gums every six hours for the whole period of the study; gut decontamination with colistin, polymyxin E 1,500,000 units enterally every eight hours for the whole period of the study; respiratory tract decontamination with cefotaxime 1 gram IV every eight hours for four days (n = 25) 2. SDD + fluconazole: 200 mg fluconazole enterally on the first day, then 100 mg every day (n = 25) 3. No intervention (n = 25) Duration of the intervention: until initiation of systemic antifungal drug according to cultures results or ICU discharge |
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Outcomes | Proven IFI Fungal colonization Follow‐up duration: two weeks from admission or the institution of systemic antifungal drug according to the cultures results |
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Type of antifungal treatment | Prophylactic | |
Funding sources | Quote: "Open access funded by Alexandria University Faculty of Medicine" | |
Declaration of interest among the primary researchers | Quote: "None declared" | |
Notes |
Country: Egypt Setting: single hospital, adult ICU Other: we did not include this study in the quantitative analysis due to high risk of bias in the key domains |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “patients were randomly categorized into three equals groups (25 patients each)” Comment: insufficient information to make a judgement |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to make a judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no placebo and no masking of the drugs. No blinding of participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "the study period was 15 days from admission...patients were excluded...if they did not complete the 15 day period of the study either due to discharge from ICU or death". Comment: The authors excluded patients who died or were discharged within the 15‐day period of intervention. The study did not report the number of these patients and the events that possibly occurred to them. Even though the primary outcome of this study is the effect of treatment in terms of reduction of severity score, colonization and infections during the study period, the missing data from patients excluded for this reason could be a potential source of bias. According to the study protocol, it was clear that these patients had been excluded retrospectively (after randomization and either discharge or death within 15 days) |
Selective reporting (reporting bias) | Low risk | Comment: the study protocol was not available but it was clear that the published report included all expected outcomes, including those that were pre‐specified |
Other bias | High risk | Comment: the study had a potential source of bias related to the specific study design used (patients were considered eligible if they were mechanically ventilated during the previous 48 hours. However, study intervention (SDD) was given from the first day of ICU admission) |