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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

A Phase II Open-Label, Single-arm Clinical Trial to Study the Safety, Efficacy and Pharmacokinetics of MK-3009 (Daptomycin) in Japanese Pediatric Participants Aged 1 to 17 Years With Complicated Skin and Soft Tissue Infections or Bacteremia Caused by Gram-positive Cocci

NCT03643952•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

1 - 17 years

Sex

ALL

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.
+1 more criteria

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.
+4 more criteria

Locations (16)

Japan Community Health Care Organization Chukyo Hospital ( Site 0030)

Nagoya, Aichi-ken, Japan

Japan Community Health care Organization Kyushu Hospital ( Site 0016)

Kitakyushu, Fukuoka, Japan

Maebashi Red Cross Hospital ( Site 0012)

Maebashi, Gunma, Japan

Kobe University Hospital ( Site 0015)

Kobe, Hyōgo, Japan

Shikoku Medical Center for Children and Adults ( Site 0027)

Zentsujichó, Kagawa-ken, Japan

Showa University Fujigaoka Hospital ( Site 0023)

Yokohama, Kanagawa, Japan

Kanagawa Children's Medical Center ( Site 0025)

Yokohama, Kanagawa, Japan

National Hospital Organization National Mie Hospital ( Site 0002)

Tsu, Mie-ken, Japan

National Hospital Organization Beppu Medical Center ( Site 0003)

Beppu, Oita Prefecture, Japan

Tokyo Metropolitan Children's Medical Center ( Site 0004)

Fuchū, Tokyo, Japan

Key Dates

Start Date

December 6, 2018

Primary Completion Date

April 7, 2020

Completion Date

April 7, 2020

Last Updated

May 13, 2022

Enrollment

ACTUAL participants

Conditions

BacteremiaSoft Tissue InfectionsSkin Diseases, Infectious

Interventions

Daptomycin for Injection

DRUG

Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia

NCT06650501

Staphylococcus Aureus EndocarditisStaphylococcus Aureus Septicemia+4 more

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RECRUITING

Treatment of Enterococcus Faecalis Bacterem

NCT07299539

Enterococcus Faecalis Bacteremia

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

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