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)

NCT03643952 | Completed Phase 2 Results

• 4 other identifiers: 3009-029MK-3009-0291841552020-001576-15
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 16

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

Keywords

methicillin-resistant S. aureus (MRSA) infections; complicated skin and soft tissue infections (cSSTI)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With an Adverse Event

  An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.

  Up to 56 days

• Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE)

  An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.

  Up to 42 days

Secondary Outcomes (8)

• Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success

  Up to 7 days following end of treatment (up to 49 days)

• Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response

  Up to 7 days following end of treatment (up to 49 days)

• Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin

  Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

• Maximum Plasma Concentration (Cmax) of Daptomycin

  Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

• Time to Maximum Plasma Concentration (Tmax) of Daptomycin

  Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment

Study Arms (1)

Daptomycin

EXPERIMENTAL

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.

Drug: Daptomycin for Injection

Interventions

Daptomycin for Injection 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.

Also known as: MK-3009

Daptomycin

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (16)

Japan Community Health Care Organization Chukyo Hospital ( Site 0030)

Nagoya, Aichi-ken, 457-8510, Japan

Location

Japan Community Health care Organization Kyushu Hospital ( Site 0016)

Kitakyushu, Fukuoka, 806-8501, Japan

Location

Maebashi Red Cross Hospital ( Site 0012)

Maebashi, Gunma, 371-0811, Japan

Location

Kobe University Hospital ( Site 0015)

Kobe, Hyōgo, 650-0017, Japan

Location

Shikoku Medical Center for Children and Adults ( Site 0027)

Zentsujichó, Kagawa-ken, 765-8507, Japan

Location

Showa University Fujigaoka Hospital ( Site 0023)

Yokohama, Kanagawa, 227-8501, Japan

Location

Kanagawa Children's Medical Center ( Site 0025)

Yokohama, Kanagawa, 232-8555, Japan

Location

National Hospital Organization National Mie Hospital ( Site 0002)

Tsu, Mie-ken, 514-0125, Japan

Location

National Hospital Organization Beppu Medical Center ( Site 0003)

Beppu, Oita Prefecture, 874-0011, Japan

Location

Tokyo Metropolitan Children's Medical Center ( Site 0004)

Fuchū, Tokyo, 183-8561, Japan

Location

Chiba University Hospital ( Site 0005)

Chiba, 260-8677, Japan

Location

Chiba Children's Hospital ( Site 0024)

Chiba, 266-0007, Japan

Location

National Hospital Organization Kumamoto Medical Center ( Site 0018)

Kumamoto, 860-0008, Japan

Location

Osaka City General Hospital ( Site 0020)

Osaka, 534-0021, Japan

Location

Saitama City Hospital ( Site 0008)

Saitama, 336-8522, Japan

Location

Nihon University Itabashi Hospital ( Site 0029)

Tokyo, 173-8610, Japan

Location

Related Publications (1)

• 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.

  PMID: 34920946 RESULT

MeSH Terms

Conditions

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

Interventions

Daptomycin; Injections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

The study was concluded due to the difficulty of enrolling pediatric patients into the study during the COVID-19 pandemic. This study concluded enrollment with 18 participants, versus the 20 that were originally planned.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: December 6, 2018
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: May 13, 2022
• Results First Posted: March 30, 2021

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (16)