Selective digestive tract decontamination and selective oropharyngeal decontamination and antibiotic resistance in patients in intensive-care units: an open-label, clustered group-randomised, crossover study

• Published in: The Lancet infectious diseases 2011-05, Vol.11 (5), p.372-380
• Main Authors: de Smet, Anne Marie GA, Dr, Kluytmans, Jan AJW, Prof, Blok, Hetty EM, MSc, Mascini, Ellen M, MD, Benus, Robin FJ, MD, Bernards, Alexandra T, MD, Kuijper, Ed J, MD, Leverstein-van Hall, Maurine A, MD, Jansz, Arjan R, MD, de Jongh, Bartelt M, MD, van Asselt, Gerard J, MD, Frenay, Ine HME, MD, Thijsen, Steven FT, MD, Conijn, Simon NM, Kaan, Jan A, MD, Arends, Jan P, MD, Sturm, Patrick DJ, MD, Bootsma, Martin CJ, PhD, Bonten, Marc JM, Prof
• Format: Article
• Language: English
• Subjects: Anti-Bacterial Agents - pharmacology; Antibacterial agents; Antibiotic resistance; Antibiotics; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antifungal Agents - pharmacology; Bacteria; Bacteria - drug effects; Biological and medical sciences; Colonization; Cross-Over Studies; Decontamination; Decontamination - methods; Drug Resistance, Bacterial; Drug Resistance, Fungal; Epidemiology. Vaccinations; Gastrointestinal Tract - microbiology; General aspects; Humans; Infectious Disease; Infectious diseases; Intensive Care Units; Medical sciences; Microorganisms; Oropharynx - microbiology; Pharmacology. Drug treatments; Prevention; Respiratory tract
• ISSN: 1473-3099; 1474-4457
• DOI: 10.1016/S1473-3099(11)70035-4

Summary Background Previously, we assessed selective digestive tract decontamination (SDD) and selective oropharyngeal decontamination (SOD) on survival and prevention of bacteraemia in patients in intensive-care units. In this analysis, we aimed to assess effectiveness of these interventions for prevention of respiratory tract colonisation and bacteraemia with highly resistant microorganisms acquired in intensive-care units. Methods We did an open-label, clustered group-randomised, crossover study in 13 intensive-care units in the Netherlands between May, 2004, and July, 2006. Participants admitted to intensive-care units with an expected duration of mechanical ventilation of more than 48 h or an expected stay of more than 72 h received SOD (topical tobramycin, colistin, and amphotericin B in the oropharynx), SDD (SOD antibiotics in the oropharynx and stomach plus 4 days' intravenous cefotaxime), or standard care. The computer-randomised order of study regimens was applied by an independent clinical pharmacist who was masked to intensive-care-unit identity. We calculated crude odds ratios (95% CI) for rates of bacteraemia or respiratory tract colonisation with highly resistant microorganisms in patients who stayed in intensive-care units for more than 3 days (ie, acquired infection). This trial is registered at http://isrctn.org , number ISRCTN35176830. Findings Data were available for 5927 (>99%) of 5939 patients, of whom 5463 (92%) were in intensive-care units for more than 3 days. 239 (13%) of 1837 patients in standard care acquired bacteraemia after 3 days, compared with 158 (9%) of 1758 in SOD (odds ratio 0·66, 95% CI 0·53–0·82), and 124 (7%) of 1868 in SDD (0·48, 0·38–0·60). Eight patients acquired bacteraemia with highly resistant microorganisms during SDD, compared with 18 patients (with 19 episodes) during standard care (0·41, 0·18–0·94; rate reduction [RR] 59%, absolute risk reduction [ARR] 0·6%) and 20 during SOD (0·37, 0·16–0·85; RR 63%, ARR 0·7%). Of the patients staying in intensive-care units for more than 3 days, we obtained endotracheal aspirate cultures for 881 (49%) patients receiving standard care, 886 (50%) receiving SOD, and 828 (44%) receiving SDD. 128 (15%) patients acquired respiratory tract colonisation with highly resistant microorganisms during standard care, compared with 74 (8%) during SDD (0·58, 0·43–0·78; RR 38%, ARR 5·5%) and 88 (10%) during SOD (0·65, 0·49–0·87; RR 32%, ARR 4·6%). Acquired respiratory tract colonisation w