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)

NCT ID: NCT03643952

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2020-04-07

Brief 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.

Conditions

Bacteremia; Soft Tissue Infections; Skin Diseases, Infectious

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daptomycin

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.

Group Type: EXPERIMENTAL

Daptomycin for Injection

Intervention Type: DRUG

Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.

Interventions

Daptomycin for Injection

Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.

Intervention Type: DRUG

Other Intervention Names

MK-3009

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Chiba University Hospital ( Site 0005)

Chiba, , Japan

Chiba Children's Hospital ( Site 0024)

Chiba, , Japan

National Hospital Organization Kumamoto Medical Center ( Site 0018)

Kumamoto, , Japan

Osaka City General Hospital ( Site 0020)

Osaka, , Japan

Saitama City Hospital ( Site 0008)

Saitama, , Japan

Nihon University Itabashi Hospital ( Site 0029)

Tokyo, , Japan

Countries

Japan

References

Iwata S, Koyama H, Murata Y. Efficacy and safety of daptomycin in Japanese pediatric participants with complicated skin and soft tissue infections or bacteremia caused by gram-positive cocci. J Infect Chemother. 2022 Mar;28(3):406-412. doi: 10.1016/j.jiac.2021.11.019. Epub 2021 Dec 15.

Reference Type: RESULT

PMID: 34920946 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MK-3009-029

Identifier Type: OTHER

Identifier Source: secondary_id

184155

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-001576-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3009-029

Identifier Type: -

Identifier Source: org_study_id