A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
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| ClinicalTrials.gov Identifier: NCT04215991 |
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Recruitment Status :
Recruiting
First Posted : January 2, 2020
Last Update Posted : March 6, 2023
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Sponsor:
Shionogi
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )
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Brief Summary:
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to < 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gram-negative Bacterial Infections Hospital Acquired Bacterial Pneumonia (HABP) Complicated Urinary Tract Infection (cUTI) Ventilator Associated Bacterial Pneumonia (VABP) | Drug: Cefiderocol Drug: Standard of Care | Phase 2 |
This study consists of a nonrandomized single-dose phase in children aged 3 months to less than 12 years with suspected or confirmed aerobic Gram-negative bacterial infections and a randomized multiple-dose, active-comparator standard of care (SOC) phase in children aged 3 months to less than 18 years with cUTI, HABP, or VABP to assess the PK, safety, and tolerability of cefiderocol in hospitalized participants requiring systemic antibiotics for an expected 5 to 14 days.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 85 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age |
| Actual Study Start Date : | February 19, 2020 |
| Estimated Primary Completion Date : | May 15, 2024 |
| Estimated Study Completion Date : | June 15, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Single Dose Phase: Cefiderocol
Participants will receive a single dose of cefiderocol administered intravenously (IV) on Day 1, in addition to standard of care. Participants weighing less than 34 kilograms (kg) will receive 60 milligrams (mg)/kg cefiderocol and participants ≥34 kg will receive 2000 mg.
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Drug: Cefiderocol
Administered intravenously over 3 hours
Other Names:
Drug: Standard of Care Standard of care administered will be selected by the investigator based on the suspected or confirmed pathogen(s) for the infection in accordance with local standards. |
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Experimental: Multiple Dose Phase: Cefiderocol
Participants will receive cefiderocol administered via IV every 8 hours for an expected 5 to 14 days in addition to standard of care. Participants weighing less than 34 kg will receive 60 mg/kg cefiderocol and participants ≥ 34 kg will receive 2000 mg. Dosage may be adjusted based on renal function.
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Drug: Cefiderocol
Administered intravenously over 3 hours
Other Names:
Drug: Standard of Care Standard of care administered will be selected by the investigator based on the suspected or confirmed pathogen(s) for the infection in accordance with local standards. |
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Active Comparator: Multiple Dose Phase: Standard of Care Alone
Participants will receive standard of care treatment according to local standards.
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Drug: Standard of Care
Standard of care administered will be selected by the investigator based on the suspected or confirmed pathogen(s) for the infection in accordance with local standards. |
Primary Outcome Measures :
- Number of Participants with Adverse Events in the Single Dose Phase [ Time Frame: 28 days ]
- Maximum Observed Plasma Concentration (Cmax) of Cefiderocol in the Single Dose Phase [ Time Frame: Day 1, 1 (cohort 2 only), 3, 3.5 (cohort 2 only), 5, and 8 hours after the start of infusion ]
- Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of Cefiderocol in the Single Dose Phase [ Time Frame: Day 1, 1 (cohort 2 only), 3, 3.5 (cohort 2 only), 5, and 8 hours after the start of infusion ]
- Apparent Terminal Elimination Half-life of Cefiderocol in the Single Dose Phase [ Time Frame: Day 1, 1 (cohort 2 only), 3, 3.5 (cohort 2 only), 5, and 8 hours after the start of infusion ]
- Number of Participants with Adverse Events in the Multiple Dose Phase [ Time Frame: Up to 28 days after last dose (33 to 42 days depending on treatment duration) ]
- Maximum Observed Plasma Concentration of Cefiderocol in the Multiple Dose Phase [ Time Frame: During one of the dosing intervals from Day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion ]
- Area Under the Plasma Concentration Time Curve Over the Dosing Interval τ (AUC0-τ) of Cefiderocol in the Multiple Dose Phase [ Time Frame: During one of the dosing intervals from Day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion ]
- Apparent Terminal Elimination Half-life of Cefiderocol in the Multiple Dose Phase [ Time Frame: During one of the dosing intervals from Day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion ]
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| Ages Eligible for Study: | 3 Months to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant's parent(s) or legally authorized representative(s) (LAR) provides written informed consent in accordance with regional- and country-specific laws and regulations
- Participant provides written informed assent, when feasible (age of assent to be determined by institutional review board/independent ethics committee [IRBs/IECs] or be consistent with local legal requirements)
- Hospitalized participant is 3 months to < 18 years of age at the time written informed consent/assent is obtained for the multiple-dose phase. Hospitalized participant is 3 months to < 12 years of age at the time written informed consent/assent is obtained for the single-dose phase.
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Single-dose phase: Participant has a suspected or confirmed infection type (including but not limited to cUTI, complicated intra-abdominal infections [cIAI], pneumonia, HABP/VABP, and sepsis or bloodstream infections [BSI]) that requires hospitalization for treatment with IV antibiotics.
Multiple-dose phase: Participant has a suspected or confirmed cUTI, HABP, or VABP that requires hospitalization for treatment with IV antibiotics
- If participant is a sexually active female of childbearing potential and has reached menarche or Tanner stage 3, participant agrees to use barrier contraception (including condom, diaphragm, or cervical cap) with spermicide or agrees to use a highly effective method of contraception (including contraceptive implant, injectable contraceptive, combination oral contraceptive, or an intrauterine [IUD] contraceptive device) from Screening up to 28 days after administration of the last dose of cefiderocol.
Exclusion Criteria:
- Participant has a documented history of any hypersensitivity or allergic reaction to any β-lactam antibiotic (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment.)
- Multiple-dose only: Participant has an infection caused only by a confirmed Gram-positive pathogen.
- Participant has a suspected or confirmed central nervous system (CNS) infection (for example, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy).
- Participant has cystic fibrosis.
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Single-dose phase: Participant has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on the Schwartz equation if ≥ 3 months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to < 18 years of age) of < 60 milliliter (mL)/ minute (min)/1.73 square meters (m^2)² at Screening .
Multiple-dose phase: Participant has an eGFR (based on the Schwartz equation if ≥ 3 months to < 1 year of age and modified Bedside Schwartz equation if ≥ 1 to < 18 years of age) of < 15 mL/min/1.73 m² at Screening.
- Participant has end-stage renal disease (ESRD), is on hemodialysis (HD), or receiving continuous venovenous hemofiltration (CVVH).
- Participant has experienced shock in the prior month or is in shock at the time of Screening.
- Participant has severe neutropenia or is severely immunocompromised.
- Participant has multiorgan failure .
- Participant with a life expectancy of < 30 days due to severity of a concurrent illness.
- Participant is a female who has a positive pregnancy test at Screening.
- Participant is a female who is breastfeeding.
- Participant has received any other investigational medicinal product (IMP) within 30 days.
- Participant has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data, including acute trauma to the pelvis or urinary tract.
- Participant is receiving vasopressor therapy at Screening.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04215991
Contacts
| Contact: Shionogi Clinical Trials Administrator Clinical Support Help Line | 800-849-9707 | Shionogiclintrials-admin@shionogi.co.jp |
Locations
Show 22 study locations
Sponsors and Collaborators
Shionogi
Investigators
| Study Director: | Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi |
| Responsible Party: | Shionogi |
| ClinicalTrials.gov Identifier: | NCT04215991 |
| Other Study ID Numbers: |
1704R2133 2019-002121-30 ( EudraCT Number ) |
| First Posted: | January 2, 2020 Key Record Dates |
| Last Update Posted: | March 6, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Infections Communicable Diseases Pneumonia Urinary Tract Infections Bacterial Infections Pneumonia, Bacterial Gram-Negative Bacterial Infections |
Disease Attributes Pathologic Processes Respiratory Tract Infections Lung Diseases Respiratory Tract Diseases Urologic Diseases Bacterial Infections and Mycoses |