TCTR20240718005
Not yet recruiting
Phase 2
A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients from Birth to less than 3 Months of Age with Suspected or Confirmed Aerobic Gram-negative Bacterial Infections
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Aerobic Gram-negative Bacterial Infections
- Sponsor
- Shionogi Inc.
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 less than 3 months (less than 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 equal or greater than 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
- •1\. Documented history of any moderate or severe hypersensitivity or allergic reaction to any beta\-lactam antibiotic
- •2\. Life expectancy of less than 72 hours after enrollment
- •3\. Urine output less than 1\.0 milliliter/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, defined as a serum creatinine level greater than 1\.5 milligrams per decilieter (133 micromoles/ liter) or an increase of 0\.3 mg per dL (17 to 27 micromol/L per day) from a previous lower value
- •6\. Acute kidney injury based on an increase in serum creatinine equal or more than 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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutationsHomozygous Familial HypercholesterolemiaMedDRA version: 14.1Level: LLTClassification code 10057100Term: Homozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2011-005400-15-GRAmgen Inc75
Active, not recruiting
Phase 1
A pharmacokinetics and safety study of cefiderocol in hospitalized pediatric patients from birth to less than 3 months of age with suspected or confirmed Gram-negative bacterial infectionsAerobic Gram-negative bacterial infectionsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]CTIS2023-503757-35-00Shionogi B.V.40
Active, not recruiting
Phase 1
Macitentan pharmacokinetics (PK) in children below 2 years of agePulmonary Arterial HypertensionMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2022-002754-74-PLACTELION Pharmacteuticals Ltd.10
Active, not recruiting
Phase 1
Macitentan pharmacokinetics (PK) in children below 2 years of ageEUCTR2022-002754-74-DEACTELION Pharmacteuticals Ltd.10
Recruiting
Not Applicable
A single-arm, open-label, multicenter study to assess molecular response of P1101 therapy in patients with polycythemia vera and elevated hematocritNeoplasmsKCT0006138The Catholic University of Korea, Seoul St. Mary's Hospital93