Study of MK-1986 (tedizolid phosphate) in subjects from birth to <12 y with acute bacterial skin and skin structure infections (ABSSSI) PIP P/226/2019
- Conditions
- Acute bacterial skin and skin structure infections (ABSSSI).MedDRA version: 20.1Level: PTClassification code 10052891Term: Skin bacterial infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2016-003884-20-LV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
1. Have a parent/legally authorized representative (LAR) who is able to give informed consent and willing and able to comply with all required study procedures . Assent is required of subjects who in the investigator’s judgment are capable of understanding the nature of the study.
2. Be male or female from birth to < 12 years of age at the time of consent
3. Have adequate venous access for collection of protocol-specified samples and administration of study drug (for subjects receiving IV study medication)
4. Have ABSSSI, defined by meeting the definition of at least 1 of the following 3 clinical syndromes:
a. Cellulitis/erysipelas defined as a diffuse skin infection, characterized as defined in the protocol
b. Major cutaneous abscess, defined as an infection characterized by a collection of pus apparent upon visual examination within the dermis or deeper that is accompanied by all conditions defined in the protocol
c. Wound infection, defined as an infection characterized by purulent drainage from a wound with surrounding erythema, edema, and induration (EEI); and is further defined by the conditions defined in the protocol
5. Have local symptoms of ABSSSI that started within 7 days before Study Day -1
6. Have a suspected or documented gram-positive infection from baseline Gram stain or culture. Specimens for culture are required for abscesses and wounds at the Screening Visit; specimens for cellulitis are to be collected according to standard practice at the site. Note: the microbiological sample must have been collected using a valid sampling technique, such as an aspirate, biopsy, incision, deep swab, etc. A superficial swab is not acceptable.
7. Have body weight = 10 kg for children from 2 to <12 years old; for children under 2 years old, weight eligibility criterion will be updated in future amendment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Has an uncomplicated skin and skin structure infection such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, and minor wound -associated foreign body reactions (e.g., stitch abscesses)
2. Has ABSSSI due to or associated with any of the conditions listed in the protocol
3. Has received antibacterial therapy for treatment of the current episode of ABSSSI unless:
• = 24 hours of effective antibacterial drug therapy with a short-acting antibacterial drug (defined as administration frequency of 1 or more doses per 24 hours)
OR
• Response to prior antibacterial therapy for the primary infection site of ABSSSI is considered by the investigator to be failure (no improvement in signs and symptoms [e.g., fever, pain, tenderness, lesion size increase]) after at least 48 hours of therapy
4. Has topical antibacterial applied and remaining on the primary lesion > 24 hours prior to randomization, except for antibiotic/antiseptic-coated dressing applied to a clean postsurgical wound
5. Has known bacteremia, severe sepsis, or septic shock at the Screening Visit
6. Has significant or life-threatening condition, disease, or organ system condition (e.g., endocarditis, meningitis)
7. Has recent history of opportunistic infections where the underlying cause of these infections is still active (e.g., leukemia, transplant, acquired immunodeficiency syndrome), or is suspected to be at risk of opportunistic infections or infection with unusual pathogens (e.g., primary immune deficiency, cystic fibrosis)
8. Has received or is receiving treatment for active tuberculosis (within 1 month)
9. Has known or suspected severe neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3)
10. Is human immunodeficiency virus (HIV) positive and has known or suspected CD4 cell count < 15%
11. Has renal impairment that requires peritoneal dialysis, plasmapheresis, hemodialysis, venovenous dialysis, or other forms of renal filtration
12. Has known or suspected severe hepatic impairment
13. Has cardiac or electrocardiogram (ECG) finding which in the opinion of the investigator would limit the subject’s ability to complete and/or participate in this clinical study. For neonates, an ECG is not required, but ECG data will be collected if available.
14. Has received investigational medicinal product within 30 days before the first administration of study drug. (Investigational product in this case refers to a product that is not approved in the country in which the subject is enrolled, for either adults or children, for any indication.)
15. Has an investigational device present or removed within 30 days before the first administration of study drug or presence of device-related infection
16. Was previously treated in tedizolid phosphate clinical studies (including this protocol)
17. Has contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation
18.Has contraindication, including hypersensitivity to all available comparator drugs.
19.Has a wound infection, and meets either of the conditions listed in the protocol
20. Is currently receiving (or scheduled to receive, while on study) topotecan, irinotecan, methotrexate or rosuvastatin
21. Is a female who is pregnant or nursing, or who is of childbearing potential and not abstinent or a male who is not abstinent
22. Has circumstances, including those of p
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method