Clinical Trials Register

Summary
EudraCT Number:	2015-004886-98
Sponsor's Protocol Code Number:	TOC110978
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-01-24
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

Expand All Collapse All

A. Protocol Information

A.2

EudraCT number

2015-004886-98

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Comparison of Safety and Efficacy between Retapamulin Ointment, 1% and Oral Linezolid in the treatment of Secondarily-Infected Traumatic Lesions and Impetigo.

A.4.1

Sponsor's protocol code number

TOC110978

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GlaxoSmithKline
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Research and Development Ltd
B.5.2	Functional name of contact point	GSK Clinical Support Help Desk
B.5.3	Address:
B.5.3.1	Street Address	Iron Bridge Road, Stockley Park West
B.5.3.2	Town/ city	Uxbridge, Middlesex
B.5.3.3	Post code	UB11 1BU
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 0208 990 44 66
B.5.6	E-mail	GSKClinicalSupportHD@gsk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Retapamulin
D.3.4	Pharmaceutical form	Ointment
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RETAPAMULIN
D.3.9.1	CAS number	224452-66-8
D.3.9.4	EV Substance Code	SUB25391
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Linezolid
D.3.2	Product code	Linezolid
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LINEZOLID
D.3.9.3	Other descriptive name	LINEZOLID
D.3.9.4	EV Substance Code	SUB08520MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Linezolid
D.3.2	Product code	Linezolid
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LINEZOLID
D.3.9.3	Other descriptive name	LINEZOLID
D.3.9.4	EV Substance Code	SUB08520MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral suspension
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

secondarily-infected traumatic lesions (SITL; excluding abscesses) or impetigo due
to methicillin-resistant Staphylococcus aureus (MRSA

E.1.1.1

Medical condition in easily understood language

Infected skin lesions

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	PT
E.1.2	Classification code	10021531
E.1.2	Term	Impetigo
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to evaluate the clinical and bacteriological efficacy
of topical retapamulin ointment, 1%, versus oral linezolid, in the treatment of subjects
with secondarily-infected traumatic lesions (SITL; excluding abscesses) or impetigo due
to methicillin-resistant Staphylococcus aureus (MRSA).

E.2.2

Secondary objectives of the trial

To evaluate the safety of topical retapamulin ointment, 1%, versus linezolid, in the
treatment of subjects with SITL (excluding abscesses) or impetigo due to MRSA.
To evaluate the efficacy and safety of topical retapamulin ointment, 1%, versus linezolid,
in the treatment of subjects with SITL (excluding abscesses) or impetigo, without regard
to pathogen.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. The subject is aged 2 months or older.
2. The subject has a secondarily infected traumatic lesion (SITL) or impetigo (bullous
or non-bullous).
3. The subject has had a negative urine pregnancy test prior to enrolment (if of
childbearing potential).
4. 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).
5. The subject and/or parent/legal guardian is willing and able to comply with the study
protocol.
6. 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.

E.4

Principal exclusion criteria

1. The subject has demonstrated a previous hypersensitivity reaction to pleuromutilins
or any component of the retapamulin ointment, or to oxazolidinones.
2. The subject has phenylketonuria (PKU) or known hypersensitivity to aspartame.
3. The subject has a secondarily infected animal/human bite, or a puncture wound.
4. The subject has an abscess; defined as a localized collection of pus caused by
suppuration buried in tissues.
5. The subject has a chronic ulcerative lesion that is likely to be polymicrobial and
unlikely to have Staphylococcus aureus as the causative agent.
6. The subject has an underlying skin disease, such as pre-existing eczematous
dermatitis, with clinical evidence of secondary infection.
7. The subject has systemic signs and symptoms of infection (e.g., a fever; defined as a
rectal temperature greater than 101° F or 38.3° C).
8. 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).
9. 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. This includes subjects who
have infected surgical wounds from an amputation.
10. The subject has received a systemic antibacterial or steroid, or has applied any
topical therapeutic agent (including glucocorticoid steroids, antibacterials and
antifungals) directly to the wound, within 24 hours of entry into the study.
11. The subject is currently receiving adrenergic agents (e.g., pseudoephedrine).
12. The subject is currently receiving serotonergic agents (i.e., antidepressants).
13. The subject has a clinical history of pseudomembranous colitis.
14. 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.
15. The subject has a history of seizures.
16. The subject has a history of severe renal failure and is undergoing dialysis.
17. The subject has a serious underlying disease that could be imminently lifethreatening.
18. 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 (i.e., surgical sterilization, intra-uterine
contraceptive device, oral contraception plus barrier contraception, other hormone
delivery systems plus barrier contraception, diaphragm or condom in combination
with contraceptive cream, jelly or foam).
19. The subject has used an investigational drug within 30 days prior to entering the
study.
20. The subject has been previously enrolled in this study
21. The subject has fructose intolerance, glucose-galactose malabsorption, or sucraseisomaltase
insufficiency.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the clinical response at follow-up (7-9 days post-therapy; Day
12-14 for retapamulin and Day 17-19 for linezolid) in subjects with MRSA as the
baseline pathogen.

E.5.1.1

Timepoint(s) of evaluation of this end point

(7 to 9 days post-therapy; ie. Day 12 to 14 for retapamulin and Day 17 to 19 for linezolid)

E.5.2

Secondary end point(s)

• Microbiological response at follow-up in subjects with MRSA as the baseline
pathogen
• Clinical response at follow-up in all subjects
• Microbiological response at follow-up in all subjects with a baseline pathogen
• Clinical outcome at end of therapy (2-4 days post-therapy; Day 7-9 for retapamulin
and Day 12-14 for linezolid) in subjects with MRSA as the baseline pathogen
• Microbiological outcome at end of therapy in subjects with MRSA as the baseline
pathogen
• Clinical outcome at end of therapy in all subjects
• Microbiological outcome at end of therapy in all subjects with a baseline pathogen
• Therapeutic response (combined clinical and microbiological response) at follow-up

E.5.2.1

Timepoint(s) of evaluation of this end point

end of therapy (2 to 4 days post-therapy; ie. Day 7 to 9 for retapamulin and Day 12 to14 for linezolid) or at follow up (7 to 9 days post-therapy ie. Day 12 to 14 for retapamulin and Day 17 to 19 for linezolid)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last subject last visit – 27-Sep-2010

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

116

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

256

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Paediatrics

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

500

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	United States

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials