title: Prescription Patterns for Tigecycline in Severely Ill Patients for Non-FDA Approved Indications in a Developing Country: A Compromised Outcome.
abstract: Introduction:With the rise in antibiotic resistance, tigecycline has been used frequently in off-label indications, based on itsin-vitroactivity against multidrug-resistant organisms. In this study, our aim was to assess its use in approved and unapproved indications.Materials and Methods:This is a retrospective chart review evaluating a 2-year experience of tigecycline use for > 72 h in 153 adult patients inside and outside critical care unit from January 2012 to December 2013 in a Lebanese tertiary-care hospital.Results:Tigecycline was mostly used in off-label indications (81%) and prescribed inside the critical care area, where the number of tigecycline cycles was 16/1,000 patient days. Clinical success was achieved in 43.4% of the patients. In the critically ill group, it was significantly higher in patients with a SOFA score <7 using multivariate analysis (Odds Ratio (OR) = 12.51 [4.29-36.51],P< 0.0001). Microbiological success was achieved in 43.3% of patients. Yet, the univariate and adjusted multivariate models failed to show a significant difference in this outcome between patients inside vs. outside critical care area, those with SOFA score <7 vs. ≥ 7, and in FDA-approved vs. off-label indications. Total mortality reached ~45%. It was significantly higher in critically ill patients with SOFA score ≥7 (OR = 5.17 [2.43-11.01],P< 0.0001) and in off-label indications (OR = 4.00 [1.30-12.31],P= 0.01) using an adjusted multivariate model. Gram-negative bacteria represented the majority of the clinical isolates (81%) andAcinetobacter baumanniipredominated (28%). Carbapenem resistance was present in 85% of the recoveredAcinetobacter, yet, more than two third of the carbapenem-resistantAcinetobacterspecies were still susceptible to tigecycline.Conclusion:In our series, tigecycline has been mostly used in off-label indications, specifically in severely ill patients. The outcome of such infections was not inferior to that of FDA-approved indications, especially inside critical care area. The use of this last resort antibiotic in complicated clinical scenarios with baseline microbiological epidemiology predominated by extensively-drug resistant pathogens ought to be organized.
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Makassed General HospitalBeirut, Lebanon; Faculty of Medicine, Beirut Arab UniversityBeirut, Lebanon; Faculty of Medical Sciences, Lebanese UniversityBeirut, Lebanon.
authors.forename: Rima A
authors.initials: RA
authors.lastname: Moghnieh
authors.affiliation: Pharmacy Department, Makassed General Hospital Beirut, Lebanon.
authors.forename: Dania I
authors.initials: DI
authors.lastname: Abdallah
authors.affiliation: Department of Infectious Diseases, University of Balamand Amioun, Lebanon.
authors.forename: Ismail A
authors.initials: IA
authors.lastname: Fawaz
authors.affiliation: Department of Internal Medicine, Makassed General Hospital Beirut, Lebanon.
authors.forename: Tarek
authors.initials: T
authors.lastname: Hamandi
authors.affiliation: Department of Internal Medicine, Makassed General Hospital Beirut, Lebanon.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Kassem
authors.affiliation: Department of Internal Medicine, Makassed General Hospital Beirut, Lebanon.
authors.forename: Nabila
authors.initials: N
authors.lastname: El-Rajab
authors.affiliation: Department of Laboratory Medicine, Makassed General Hospital Beirut, Lebanon.
authors.forename: Tamima
authors.initials: T
authors.lastname: Jisr
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Makassed General Hospital Beirut, Lebanon.
authors.forename: Anas
authors.initials: A
authors.lastname: Mugharbil
authors.affiliation: Pharmacy Department, Makassed General Hospital Beirut, Lebanon.
authors.forename: Nabila
authors.initials: N
authors.lastname: Droubi
authors.affiliation: Faculty of Health Sciences, American University of Beirut Beirut, Lebanon.
authors.forename: Samaa
authors.initials: S
authors.lastname: Al Tabah
authors.affiliation: Makassed General Hospital Beirut, Lebanon.
authors.forename: Loubna
authors.initials: L
authors.lastname: Sinno
authors.affiliation: Faculty of Public Health, Lebanese University Beirut, Lebanon.
authors.forename: Fouad
authors.initials: F
authors.lastname: Ziade
authors.affiliation: Clinical Microbiology, Faculty of Medicine and Medical Sciences, University of Balamand Amioun, Lebanon.
authors.forename: Ziad
authors.initials: Z
authors.lastname: Daoud
authors.affiliation: Faculty of Medical Sciences, Lebanese UniversityBeirut, Lebanon; Pharmacy Department, Makassed General HospitalBeirut, Lebanon; Division of Hematology-Oncology, Department of Internal Medicine, Makassed General HospitalBeirut, Lebanon.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Ibrahim
keywords: Acinetobacter baumannii; antibiotic resistance; antibiotic stewardship; critically ill; off-label indications; tigecycline