ID

35399

Beschrijving

Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the eligibility criteria form. It has to be filled in for screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00852540

Trefwoorden

Versies (2)
  1. 04-03-19 04-03-19 -
  2. 07-03-19 07-03-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

4 maart 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540

Engels

Eligibility criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Eligibility question
Beschrijving

Eligibility question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschrijving

If you tick No, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Datatype

text

Inclusion criteria
Beschrijving

Inclusion criteria

Alias
UMLS CUI-1
C1512693
The subject is aged 2 months or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
The subject has a secondarily infected traumatic lesion (SITL) or impetigo (bullous or non-bullous).
Beschrijving

Secondarily infected traumatic lesion/ Impetigo

Datatype

boolean

Alias
UMLS CUI [1]
C0497369
UMLS CUI [2]
C0021099
The subject has had a negative urine pregnancy test prior to enrolment (if of childbearing potential).
Beschrijving

Negative urine pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
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).
Beschrijving

Skin Infection Rating Scale, total score, pus/exsudate score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037278
UMLS CUI [1,2]
C0681889
UMLS CUI [1,3]
C2964552
UMLS CUI [2,1]
C0015388
UMLS CUI [2,2]
C2964552
UMLS CUI [3,1]
C0034161
UMLS CUI [3,2]
C2964552
The subject and/or parent/legal guardian is willing and able to comply with the study protocol.
Beschrijving

Complying with study protocol (Subject, Parent, legal Guardian)

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0023226
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.
Beschrijving

Informed consent (Subject, Parent, legal Guardian)

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0023226
Exclusion criteria
Beschrijving

Exclusion criteria

Alias
UMLS CUI-1
C0680251
The subject has demonstrated a previous hypersensitivity reaction to pleuromutilins or any component of the retapamulin ointment, or to oxazolidinones.
Beschrijving

Hypersensitivity reaction to pleuromutilins/ any component of study drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0071283
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0887953
The subject has phenylketonuria (PKU) or known hypersensitivity to aspartame.
Beschrijving

Phenylketonuria/ hypersensitivity to aspartame

Datatype

boolean

Alias
UMLS CUI [1]
C0031485
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003999
The subject has a secondarily infected animal/human bite, or a puncture wound.
Beschrijving

Secondarily infected animal/human bite/ puncture wound

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003062
UMLS CUI [1,2]
C0266061
UMLS CUI [1,3]
C3714514
UMLS CUI [2,1]
C0086418
UMLS CUI [2,2]
C0266061
UMLS CUI [2,3]
C3714514
UMLS CUI [3,1]
C0033119
UMLS CUI [3,2]
C3714514
The subject has an abscess
Beschrijving

An Abscess is defined as a localized collection of pus caused by suppuration buried in tissues

Datatype

boolean

Alias
UMLS CUI [1]
C0000833
The subject has a chronic ulcerative lesion that is likely to be polymicrobial and unlikely to have Staphylococcus aureus as the causative agent.
Beschrijving

Chronic ulcerative lesion (polymicrobial likely, S. aureus unlikely)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0333297
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0750492
UMLS CUI [1,4]
C0238748
UMLS CUI [2,1]
C0333297
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0750558
UMLS CUI [2,4]
C0038172
The subject has an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection.
Beschrijving

Skin disease (e.g. pre-existing eczematous dermatitis)

Datatype

boolean

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0270838
UMLS CUI [1,3]
C0009450
UMLS CUI [2,1]
C0521987
UMLS CUI [2,2]
C0011603
UMLS CUI [2,3]
C0013595
The subject has systemic signs and symptoms of infection (e.g., a fever)
Beschrijving

Definition of fever: a rectal temperature greater than 101o F or 38.3 °C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C3714514
UMLS CUI [2]
C0015967
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).
Beschrijving

Bacterial skin infection (e.g., extensive cellulitis, furunculosis)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205231
UMLS CUI [1,2]
C0037278
UMLS CUI [1,3]
C0004623
UMLS CUI [2,1]
C0205231
UMLS CUI [2,2]
C0205231
UMLS CUI [2,3]
C0007642
UMLS CUI [3]
C0016867
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.
Beschrijving

Surgical intervention (incision and drainage)

Datatype

boolean

Alias
UMLS CUI [1]
C0549433
UMLS CUI [2]
C0184898
UMLS CUI [3]
C0180499
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.
Beschrijving

Systemic antibacterial/ steroid, topical therapeutic agent (glucocorticoid steroids, antibacterials and antifungals)

Datatype

boolean

Alias
UMLS CUI [1]
C0854606
UMLS CUI [2]
C2825233
UMLS CUI [3,1]
C0332237
UMLS CUI [3,2]
C0038317
UMLS CUI [4,1]
C0332237
UMLS CUI [4,2]
C1579346
UMLS CUI [5,1]
C0332237
UMLS CUI [5,2]
C0003308
The subject is currently receiving adrenergic agents (e.g., pseudoephedrine).
Beschrijving

Adrenergic agents (e.g., pseudoephedrine)

Datatype

boolean

Alias
UMLS CUI [1]
C0001637
UMLS CUI [2]
C0033798
The subject is currently receiving serotonergic agents (i.e., antidepressants).
Beschrijving

Serotonergic agents (i.e., antidepressants)

Datatype

boolean

Alias
UMLS CUI [1]
C0242701
UMLS CUI [2]
C0003289
The subject has a clinical history of pseudomembranous colitis.
Beschrijving

History of pseudomembranous colitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1257843
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.
Beschrijving

Myelosuppression, bone marrow suppression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C0854467
UMLS CUI [1,3]
C0663241
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0854467
UMLS CUI [2,3]
C0663241
UMLS CUI [3,1]
C0280962
UMLS CUI [3,2]
C0458082
The subject has a history of seizures.
Beschrijving

History of seizures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0036572
The subject has a history of severe renal failure and is undergoing dialysis.
Beschrijving

History of severe renal failure, dialysis

Datatype

boolean

Alias
UMLS CUI [1]
C1533077
UMLS CUI [2]
C0011946
The subject has a serious underlying disease that could be imminently life-threatening.
Beschrijving

Serious disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C1517874
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.
Beschrijving

Pregnancy/breast feading, childbearing potential, method of contraception, post-menopausal

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0232970
The subject has used an investigational drug within 30 days prior to entering the study.
Beschrijving

Use of investigational drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524063
The subject has been previously enrolled in this study.
Beschrijving

Previously enrolled in study

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1516879
The subject has fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
Beschrijving

Fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C0016751
UMLS CUI [2]
C0865194
UMLS CUI [3,1]
C0038635
UMLS CUI [3,2]
C0231179
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Similar models

Eligibility criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility question
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
Entry criteria
Code List
Did the subject meet all the entry criteria?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
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
C1123023 (UMLS CUI [1,1])
C0270838 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0521987 (UMLS CUI [2,1])
C0011603 (UMLS CUI [2,2])
C0013595 (UMLS CUI [2,3])
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])
C0205231 (UMLS CUI [2,2])
C0007642 (UMLS CUI [2,3])
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 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])
C1517874 (UMLS CUI [2])
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])
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