Age
Item
The subject is aged 2 months or older.
boolean
C0001779 (UMLS CUI [1])
Secondarily infected traumatic lesion/ Impetigo
Item
The subject has a secondarily infected traumatic lesion (SITL) or impetigo (bullous or non-bullous).
boolean
C0497369 (UMLS CUI [1])
C0021099 (UMLS CUI [2])
Negative urine pregnancy test
Item
The subject has had a negative urine pregnancy test prior to enrolment (if of childbearing potential).
boolean
C0427780 (UMLS CUI [1])
Skin Infection Rating Scale, total score, pus/exsudate score
Item
The subject has a Total Skin Infection Rating Scale (SIRS) Score of at least 8, which must include a pus/exudate score of at least 3 (see Appendix 1).
boolean
C0037278 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C2964552 (UMLS CUI [1,3])
C0015388 (UMLS CUI [2,1])
C2964552 (UMLS CUI [2,2])
C0034161 (UMLS CUI [3,1])
C2964552 (UMLS CUI [3,2])
Complying with study protocol (Subject, Parent, legal Guardian)
Item
The subject and/or parent/legal guardian is willing and able to comply with the study protocol.
boolean
C0525058 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
Informed consent (Subject, Parent, legal Guardian)
Item
The subject or parent/legal guardian, as applicable, has given written informed, dated consent; and the subject has given written assent, if applicable, to participate in the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
Hypersensitivity reaction to pleuromutilins/ any component of study drugs
Item
The subject has demonstrated a previous hypersensitivity reaction to pleuromutilins or any component of the retapamulin ointment, or to oxazolidinones.
boolean
C0020517 (UMLS CUI [1,1])
C0071283 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0887953 (UMLS CUI [3,2])
Phenylketonuria/ hypersensitivity to aspartame
Item
The subject has phenylketonuria (PKU) or known hypersensitivity to aspartame.
boolean
C0031485 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0003999 (UMLS CUI [2,2])
Secondarily infected animal/human bite/ puncture wound
Item
The subject has a secondarily infected animal/human bite, or a puncture wound.
boolean
C0003062 (UMLS CUI [1,1])
C0266061 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
C0086418 (UMLS CUI [2,1])
C0266061 (UMLS CUI [2,2])
C3714514 (UMLS CUI [2,3])
C0033119 (UMLS CUI [3,1])
C3714514 (UMLS CUI [3,2])
Abscess
Item
The subject has an abscess
boolean
C0000833 (UMLS CUI [1])
Chronic ulcerative lesion (polymicrobial likely, S. aureus unlikely)
Item
The subject has a chronic ulcerative lesion that is likely to be polymicrobial and unlikely to have Staphylococcus aureus as the causative agent.
boolean
C0333297 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0750492 (UMLS CUI [1,3])
C0238748 (UMLS CUI [1,4])
C0333297 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0750558 (UMLS CUI [2,3])
C0038172 (UMLS CUI [2,4])
Skin disease (e.g. pre-existing eczematous dermatitis)
Item
The subject has an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection.
boolean
C3714514 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,3])
C0011603 (UMLS CUI [2,1])
C0162817 (UMLS CUI [2,2])
Systemic signs and symptoms of infection (e.g. fever)
Item
The subject has systemic signs and symptoms of infection (e.g., a fever)
boolean
C0037088 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
Bacterial skin infection (e.g., extensive cellulitis, furunculosis)
Item
The subject has a bacterial skin infection which, due to extent, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic (e.g., extensive cellulitis, furunculosis).
boolean
C0205231 (UMLS CUI [1,1])
C0037278 (UMLS CUI [1,2])
C0004623 (UMLS CUI [1,3])
C0205231 (UMLS CUI [2,1])
C0007642 (UMLS CUI [2,2])
C0016867 (UMLS CUI [3])
Surgical intervention (incision and drainage)
Item
The subject requires surgical intervention including, but not limited to, incision and drainage, for treatment of the infection prior to enrollment in the study or is likely to require such intervention during the course of the study.
boolean
C0549433 (UMLS CUI [1])
C0184898 (UMLS CUI [2])
C0180499 (UMLS CUI [3])
Systemic antibacterial/ steroid, topical therapeutic agent (glucocorticoid steroids, antibacterials and antifungals)
Item
The subject has received a systemic antibacterial or steroid, or has applied any of topical therapeutic agent (including glucocorticoid steroids, antibacterials and antifungals) directly to the wound, within 24 hours of entry into the study.
boolean
C0854606 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
C0332237 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C0332237 (UMLS CUI [4,1])
C1579346 (UMLS CUI [4,2])
C0332237 (UMLS CUI [5,1])
C0003308 (UMLS CUI [5,2])
Adrenergic agents (e.g., pseudoephedrine)
Item
The subject is currently receiving adrenergic agents (e.g., pseudoephedrine).
boolean
C0001637 (UMLS CUI [1])
C0033798 (UMLS CUI [2])
Serotonergic agents (i.e., antidepressants)
Item
The subject is currently receiving serotonergic agents (i.e., antidepressants).
boolean
C0242701 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
History of pseudomembranous colitis
Item
The subject has a clinical history of pseudomembranous colitis.
boolean
C0262926 (UMLS CUI [1,1])
C1257843 (UMLS CUI [1,2])
Myelosuppression, bone marrow suppression
Item
The subject has known, pre-existing myelosuppression, or a history of myelosuppression with prior linezolid use, or is currently receiving a medication that produces bone marrow suppression.
boolean
C0521987 (UMLS CUI [1,1])
C0854467 (UMLS CUI [1,2])
C0663241 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0854467 (UMLS CUI [2,2])
C0663241 (UMLS CUI [2,3])
C0280962 (UMLS CUI [3,1])
C0458082 (UMLS CUI [3,2])
History of seizures
Item
The subject has a history of seizures.
boolean
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
History of severe renal failure, dialysis
Item
The subject has a history of severe renal failure and is undergoing dialysis.
boolean
C1533077 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Serious, life-threatening disease
Item
The subject has a serious underlying disease that could be imminently life-threatening.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
Pregnancy/breast feading, childbearing potential, method of contraception, post-menopausal
Item
The subject is pregnant, breast feeding or planning a pregnancy during the study, or of childbearing potential or less than one year post-menopausal and not using an accepted method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
Use of investigational drug
Item
The subject has used an investigational drug within 30 days prior to entering the study.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Previously enrolled in study
Item
The subject has been previously enrolled in this study.
boolean
C2348568 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency
Item
The subject has fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
boolean
C0016751 (UMLS CUI [1])
C0865194 (UMLS CUI [2])
C0038635 (UMLS CUI [3,1])
C0231179 (UMLS CUI [3,2])