Clinical Trials List
Protocol Number1904R2136
NCT Number(ClinicalTrials.gov Identfier)NCT06086626
Completed
2023-10-31 - 2025-06-12
Phase II
Not yet recruiting1
Recruiting1
ICD-10A41.50
Gram-negative sepsis, unspecified
ICD-10R65.10
Systemic inflammatory response syndrome (SIRS) of non-infectious origin without acute organ dysfunction
ICD-10R65.11
Systemic inflammatory response syndrome (SIRS) of non-infectious origin with acute organ dysfunction
ICD-10R65.20
Severe sepsis without septic shock
ICD-9038.40
Septicemia due to Gram-negative organism, unspecified
A multicenter, single-arm, open-label study to assess the pharmacokinetics, safety, and tolerability of cefiderocol in hospitalized pediatric patients from birth to < 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections
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Sponsor
PPD DEVELOPMENT (HK) LIMITED TAIWAN BRANCH
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 曹伯年 Division of Pediatrics
- 周昱廷 Division of Pediatrics
- Luan-Yin Chang Division of Pediatrics
- 黃冠穎 Division of Pediatrics
- 黃昱璁 Division of Others
- TING-YU YEN Division of Pediatrics
- 金彥杰 Division of Pediatrics
- 黃冠穎 Division of Pediatrics
- Chun-yi Lu Division of Pediatrics
- 何昇原 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Cheng-Hsun Chiu
Co-Principal Investigator
- 朱世明 Division of Pediatrics
- 李恩沛 Division of Pediatrics
- Jen Fu Hsu Division of Pediatrics
- 賴美吟 Division of Pediatrics
- 吳怡萱 Division of Pediatrics
- 林瑞瑩 Division of Pediatrics
- 傅仁煇 Division of Pediatrics
- 江明洲 Division of Pediatrics
- 林建志 Division of Pediatrics
- 許凱翔 Division of Pediatrics
- 李建忠 Division of Pediatrics
- 夏紹軒 Division of Pediatrics
- 楊長佑 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Gram-Negative Bacterial Infections
Objectives
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.
Test Drug
Cefiderocol
Active Ingredient
Cefiderocol
Dosage Form
Injection
Dosage
GM
Endpoints
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
Cmax After a Minimum of 4 Doses of Cefiderocol
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Cefiderocol
Cmax After a Minimum of 4 Doses of Cefiderocol
Inclution Criteria
Key Inclusion Criteria:
1. Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements
2. Hospitalized infants from birth to < 3 months (< 90 days) of age at the time written informed consent is provided. Enrollment of premature infants will not be restricted, but they must have a GA ≥ 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg)
3. Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram-negative infections including, but not limited to, complicated urinary tract infection, complicated intra-abdominal infection, hospital-acquired/ ventilator-associated bacterial pneumonia, and BSI/sepsis
4. For the multiple-dose phase, within 72 hours of the start of potentially effective treatment with SOC antibiotics for the suspected or confirmed primary aerobic Gram-negative infection
1. Written informed consent has been provided by parent(s) or legally authorized representative(s) in accordance with local regulatory requirements
2. Hospitalized infants from birth to < 3 months (< 90 days) of age at the time written informed consent is provided. Enrollment of premature infants will not be restricted, but they must have a GA ≥ 26 weeks, PNA of 0 to 3 months, and weight of at least 1 kilogram (kg)
3. Require systemic IV antibiotic treatment for suspected or confirmed aerobic Gram-negative infections including, but not limited to, complicated urinary tract infection, complicated intra-abdominal infection, hospital-acquired/ ventilator-associated bacterial pneumonia, and BSI/sepsis
4. For the multiple-dose phase, within 72 hours of the start of potentially effective treatment with SOC antibiotics for the suspected or confirmed primary aerobic Gram-negative infection
Exclusion Criteria
Key Exclusion Criteria:
1. Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
2. Life expectancy of < 72 hours after enrollment
3. Urine output < 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1
4. Serum creatinine value greater than the maximum for GA and PNA shown below within the 24 hours prior to study drug administration on Day 1
5. Neonatal acute kidney injury (AKI), defined as a serum creatinine level greater than 1.5 milligrams per decilieter (mg/dL) (133 micromoles[μmol]/liter [L]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value
6. Acute kidney injury based on an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours from an established baseline value
7. 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
8. Receiving renal replacement therapy
9. Received any other investigational medicinal product within 30 days of study drug administration
10. Receiving treatment with a vasopressor at Screening
11. Has a confirmed or strongly suspected infection at Screening with a pathogen known to be resistant to cefiderocol or only a Gram-positive pathogen or viral, fungal, or parasitic pathogen as the sole cause of infection
12. Anticipated need for antibacterial therapy longer than 14 days (example , osteomyelitis or endocarditis); this applies to both study treatment with cefiderocol, as well as adjunctive IV antibacterial treatment for suspected coinfection with Gram-positive organisms or multidrug resistant Gram-negative organisms
13. Suspected or confirmed central nervous system (CNS) infection, including suspected CNS infection who do not have a lumbar puncture (LP) but who are treated for potential CNS infection, evidence suggestive of CNS infection based on LP results (polymorphonuclear pleocytosis, hypoglycorrhachia, and increased protein concentration), regardless of culture results, LP with organisms on Gram stain or culture-positive cerebrospinal fluid
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
1. Documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic
2. Life expectancy of < 72 hours after enrollment
3. Urine output < 1.0 milliliter (mL)/kg/hour within the 24 hours prior to study drug administration on Day 1
4. Serum creatinine value greater than the maximum for GA and PNA shown below within the 24 hours prior to study drug administration on Day 1
5. Neonatal acute kidney injury (AKI), defined as a serum creatinine level greater than 1.5 milligrams per decilieter (mg/dL) (133 micromoles[μmol]/liter [L]) or an increase of 0.3 mg/dL (17 to 27 μmol/L) per day from a previous lower value
6. Acute kidney injury based on an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours from an established baseline value
7. 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
8. Receiving renal replacement therapy
9. Received any other investigational medicinal product within 30 days of study drug administration
10. Receiving treatment with a vasopressor at Screening
11. Has a confirmed or strongly suspected infection at Screening with a pathogen known to be resistant to cefiderocol or only a Gram-positive pathogen or viral, fungal, or parasitic pathogen as the sole cause of infection
12. Anticipated need for antibacterial therapy longer than 14 days (example , osteomyelitis or endocarditis); this applies to both study treatment with cefiderocol, as well as adjunctive IV antibacterial treatment for suspected coinfection with Gram-positive organisms or multidrug resistant Gram-negative organisms
13. Suspected or confirmed central nervous system (CNS) infection, including suspected CNS infection who do not have a lumbar puncture (LP) but who are treated for potential CNS infection, evidence suggestive of CNS infection based on LP results (polymorphonuclear pleocytosis, hypoglycorrhachia, and increased protein concentration), regardless of culture results, LP with organisms on Gram stain or culture-positive cerebrospinal fluid
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
40 participants
