Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subject… (NCT03643952) | Clinical Trial Compass
CompletedPhase 2
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
Japan18 participantsStarted 2018-12-06
Plain-language summary
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection (cSSTI) or bacteremia caused by gram-positive cocci.
Who can participate
Age range1 Year – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Requires treatment for cSSTI or bacteremia.
* Is male or female Japanese aged ≥ 1 to ≤ 17 years on the day of signing informed consent.
* As a male participant, has agreed to use contraception during the treatment period and for at least 14 days after the last dose of study treatment and refrain from donating sperm during this period.
* As a female participant, has agreed to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment.
* Has agreed to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided the Central Microbiology Reference Laboratory for study-related microbiological testing, long-term storage, and other future testing.
cSSTI Participants
* Has cSSTI known or suspected to be caused by gram-positive cocci that requires intravenous antibiotic treatment and diagnosed with either Gram stain or culture.
* Has at least 3 of the following clinical signs and symptoms associated with the cSSTI: pain, tenderness to palpation, temperature \>37.0°C axillary or \>37.5°C oral or \>38.0° C rectal, forehead, or aural, white blood count (WBC) \>12,000/mm\^3 or ≥10% bands, swelling and/or induration, erythema (\>1 cm beyond edge of wound or abscess)…
What they're measuring
1
Percentage of Participants With an Adverse Event
Timeframe: Up to 56 days
2
Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE)