A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants Fr… (NCT03176134) | Clinical Trial Compass
CompletedPhase 3
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
United States100 participantsStarted 2019-01-20
Plain-language summary
This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).
Who can participate
Age range1 Day – 11 Years
SexALL
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Inclusion Criteria:
* Has a parent/legally acceptable representative who is able to give documented informed consent
* Has acute bacterial skin and skin structure infections (ABSSSI), defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection
* Local symptoms of ABSSSI that started within 14 days before study start
* Suspected or documented Gram-positive bacterial infection
Exclusion Criteria:
* Uncomplicated skin and skin structure infection
* ABSSSI due to or associated with disallowed etiology per protocol
* Received antibacterial therapy for treatment of the current episode of ABSSSI except 1) \<48 hours of antibacterial therapy with a short-acting antibacterial drug, or 2) response is considered to be failure (no improvement in signs and symptoms) after at least 48 hours of therapy
* Known bacteremia, severe sepsis, or septic shock
* Significant or life-threatening condition, disease, or organ system condition
* Recent history of opportunistic infections where the underlying cause of the infection is still active, or is suspected to be at risk of opportunistic infection with unusual pathogens
* Received or is receiving treatment for active tuberculosis within 1 month of study start
* Known or suspected severe neutropenia
* Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4 cell count \<15% (HIV testing is not required for eligibility)
* Renal impairment that requires renal filtration
*…
What they're measuring
1
Number of Participants Who Experienced an Adverse Event (AE)
Timeframe: Up to approximately 35 days
2
Number of Participants Who Discontinued Study Treatment Due to an AE
Timeframe: Up to approximately day 15
3
Number of Participants With Hematopoietic Cytopenias