NCT05314764CompletedPhase 4
Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis
Population Pharmacokinetics of Cefiderocol During Acute Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 29 Mar 2022
- Start date
- 1 Jun 2022
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- Hartford Hospital
- Diseases
- Cystic fibrosis
- NCT number
- NCT05314764
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 10
- From 1 Jun 2022 to the primary completion date, 1 Jun 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)
- History of a lung transplant at any time in the past or any other organ transplantation (e.g., liver) within the last 6 months
- Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
Lab values
- Moderate to severe renal dysfunction defined as a creatinine clearance \< 60 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
- A hemoglobin less than 8 gm/dL at baseline
Other
- Females that are pregnant and/or breastfeeding
Who the study is looking for
- Documented diagnosis of CF
- Acute pulmonary exacerbation as the primary reason for admission to the hospital with requirement to receive systemic antibiotic treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Clements University Hospital Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| IU Health University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| UPMC Presbyterian Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.