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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Skin Diseases, Infectious; Bacteremia; Soft Tissue Infections

Treatments: Drug: Daptomycin for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03643952

MK-3009-029 (Other Identifier)

3009-029

184155 (Registry Identifier)

2020-001576-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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), pus formation, CRP > upper limited of normal.

Bacteremia Participants

• Have proven bacteremia with pathogen identification of gram-positive cocci at least one blood culture bottle by conventional culture methods or by a rapid diagnostic test in screening period.
• Have probable bacteremia with a blood culture result demonstrating gram-positive cocci by Gram stain in screening period.

Exclusion criteria

• Has received previous systemic antimicrobial therapy that is effective against gram-positive cocci and exceeding 72 hours duration administered at any time during the 96 hours prior to the first dose of study drug.
• Has a known infection caused solely by gram-negative pathogen(s), fungus(i) or virus(es).
• Has pneumonia (septic emboli in the lung is not an exclusion if clear evidence of source of infection is other than lungs), empyema, meningitis, endocarditis, or osteoarticular infection.
• Has a history of or current rhabdomyolysis.
• Is anticipated to require non-study systemic antibiotics that may be potentially effective against gram-positive pathogen(s).
• Has shock or hypotension unresponsive to fluids or vasopressors for ≥ 4 hours.
• Has significant allergy/hypersensitivity or intolerance to daptomycin.
• Has renal insufficiency.
• Has a history of clinically significant (as assessed by the Investigator) muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre or spinal cord injury; previous uncomplicated febrile seizure allowed.
• Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the participant to risk by participating in the trial, confound the results of the trial, or interfere with the participant's participation for the full duration of the trial.
• Is a female who is pregnant or is expecting to conceive (or is a male partner of a female who is expecting to conceive), is breastfeeding, or plans to breastfeed prior to completion of the study.
• Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 30 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial.
• Has previously participated in this study at any time.
• Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Daptomycin

Experimental group

Description:

Participants aged 1 to 17 years old with cSSTI or bacteremia will receive daptomycin intravenously every 24 hours for either 5-14 days for cSSTI or for 5-42 days for bacteremia.

Treatment:

Drug: Daptomycin for Injection