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BacteremiaPhase 2NCT03643952

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 2 study testing Daptomycin for Injection in people with Bacteremia and Soft Tissue Infections, run by Merck Sharp & Dohme LLC at 16 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 17 years
What is being tested?
Daptomycin for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
16 sitesJapan
Study dates
6 Dec 2018to 7 Apr 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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 locations and contacts

16 sites in 1 country.

16 sites in 1 country

Japan16 sites

  • National Hospital Organization Beppu Medical Center ( Site 0003)

    Beppu, Oita Prefecture, 874-0011

  • Chiba University Hospital ( Site 0005)

    Chiba, 260-8677

  • Chiba Children's Hospital ( Site 0024)

    Chiba, 266-0007

  • Tokyo Metropolitan Children's Medical Center ( Site 0004)

    Fuchū, Tokyo, 183-8561

  • Japan Community Health care Organization Kyushu Hospital ( Site 0016)

    Kitakyushu, Fukuoka, 806-8501

  • Kobe University Hospital ( Site 0015)

    Kobe, Hyōgo, 650-0017

  • National Hospital Organization Kumamoto Medical Center ( Site 0018)

    Kumamoto, 860-0008

  • Maebashi Red Cross Hospital ( Site 0012)

    Maebashi, Gunma, 371-0811

  • Japan Community Health Care Organization Chukyo Hospital ( Site 0030)

    Nagoya, Aichi-ken, 457-8510

  • Osaka City General Hospital ( Site 0020)

    Osaka, 534-0021

  • Saitama City Hospital ( Site 0008)

    Saitama, 336-8522

  • Nihon University Itabashi Hospital ( Site 0029)

    Tokyo, 173-8610

  • National Hospital Organization National Mie Hospital ( Site 0002)

    Tsu, Mie-ken, 514-0125

  • Showa University Fujigaoka Hospital ( Site 0023)

    Yokohama, Kanagawa, 227-8501

  • Kanagawa Children's Medical Center ( Site 0025)

    Yokohama, Kanagawa, 232-8555

  • Shikoku Medical Center for Children and Adults ( Site 0027)

    Zentsujichó, Kagawa-ken, 765-8507

Other trials in Japan

About this study

Official title: 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

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.

Being tested
Daptomycin for Injection
Keywords
methicillin-resistant S. aureus (MRSA) infections, complicated skin and soft tissue infections (cSSTI)
Medical subject headings
Bacteremia, Soft Tissue Infections, Skin Diseases, Infectious, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daptomycin for InjectionDrug

    Also called MK-3009

    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.

Study groups in NCT03643952
Study groupRoleWhat they receive
DaptomycinExperimentalParticipants 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.
Receives: Drug: Daptomycin for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 56 days

  2. 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.

    Measured: Up to 42 days

Secondary outcomes (8)

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

    Clinical success in participants with MRSA infections was defined as either "Cure" - Resolution of clinically significant signs and symptoms associated with admission infection and no further antibiotic therapy required, OR "Improved"- partial resolution of clinical signs or symptoms of infection with no further antibiotic therapy required.

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

  2. Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response

    Participant-level microbiological response in participants with MRSA infections at baseline is defined as absence or presumed absence of all baseline infecting pathogens AND no gram-positive superinfection or gram-positive new infection, as assessed by infection site specimen culture or blood culture.

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

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

    Blood samples were collected at pre-specified time points to determine the AUC0-24 of daptomycin.

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

  4. Maximum Plasma Concentration (Cmax) of Daptomycin

    Blood samples were collected at pre-specified timepoints to determine Cmax of daptomycin.

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

  5. Time to Maximum Plasma Concentration (Tmax) of Daptomycin

    Blood samples were collected at pre-specified time points to determine Tmax of daptomycin

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

  6. Body Weight Adjusted Clearance (CLss/wt) of Daptomycin

    Blood samples were collected at pre-specified time points to determine CLss/wt of daptomycin at steady state.

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

  7. Volume of Distribution at Steady State (Vss) of Daptomycin

    Blood samples were collected at pre-specified time points to determine Vss (mL) of daptomycin.

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

  8. Apparent Terminal Half-Life (t½) of Daptomycin

    Blood samples were collected at pre-specified time points to determine the t½ of daptomycin.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2018
  2. Study start6 Dec 2018
  3. Primary completion7 Apr 2020
  4. Study completion7 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03643952
Sponsor's protocol ID
3009-029
Other IDs
MK-3009-029, 184155, 2020-001576-15
Status last verified
Apr 2022
First submitted
21 Aug 2018
Last updated
13 May 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 34920946

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daptomycin for Injection in people with Bacteremia and Soft Tissue Infections, run by Merck Sharp & Dohme LLC at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an Adverse Event (time frame: Up to 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03643952, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.

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