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

Phase 1

• Conditions: secondarily-infected traumatic lesions (SITL; excluding abscesses) or impetigo dueto methicillin-resistant Staphylococcus aureus (MRSA; MedDRA version: 19.1Level: PTClassification code 10021531Term: ImpetigoSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-004886-98-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-24
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 500

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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 116
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 28

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified