Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and… (NCT04126031) | Clinical Trial Compass
TerminatedPhase 2
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
Stopped: Following regulatory consultation, the Sponsor has decided to terminate the study and analyze the current dataset. The decision to terminate was solely based on a business decision, not due to safety concerns.
United States48 participantsStarted 2020-01-14
Plain-language summary
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.
Who can participate
Age range0 Days – 88 Days
SexALL
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Inclusion criteria
✓. Evidence of a personally signed and dated informed consent document indicating that the subject's parent(s), legal guardian, or legally acceptable representative has been informed of all pertinent aspects of the study.
✓. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
✓. Male or female neonates and infants with age at Screening:
✓. Hospitalized with suspected or confirmed aerobic Gram-negative bacterial infection requiring intravenous antibacterial therapy.
✓. Subjects must meet at least 1 clinical and 1 laboratory criterion or meet at least 2 of the clinical criteria:
✓. Hypothermia (\<36ºC) OR fever (\>38.5ºC);
✓. Bradycardia OR tachycardia OR rhythm instability;
✓. Urine output 0.5 to 1 mL/kg/h OR hypotension OR mottled skin OR impaired peripheral perfusion;
Exclusion criteria
✕
What they're measuring
1
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours Post-dose: Part A
Timeframe: 2 hours post dose on Day 1
2
Plasma Concentrations of Ceftazidime and Avibactam 2 Hours and 30 Minutes Post-dose: Part A
Timeframe: 2 hours and 30 minutes post dose on Day 1
3
Plasma Concentrations of Ceftazidime and Avibactam of 7 Hours Post-dose: Part A
Timeframe: 7 hours post dose on Day 1
4
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part B
Timeframe: Day 1 up to maximum of Day 49
5
Number of Participants Who Died: Part B
Timeframe: Day 1 up to maximum of Day 49
6
Number of Participants Who Discontinued Treatment and Study Due to AEs: Part B
Timeframe: Day 1 up to maximum of Day 49
7
Number of Participants With Clinically Significant Laboratory Parameters Occurred in More Than 2 Participants: Part B
. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
✕. Participation in another clinical study involving investigational drug(s) within 30 days prior to study entry and/or during this study participation or have previously participated in the current study or in another study of CAZ-AVI (in which an active agent was received).
✕. Use of potent inhibitors of organic anion transporters OAT1 and/or OAT3 (eg, probenecid, p-aminohippuric acid (PAH), or teriflunomide) are prohibited. This prohibition of OAT1 and/or OAT3 inhibitors also applies to the mothers of any neonates or infants who are breast feeding during the trial.
✕. Other acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
✕. Documented history of any hypersensitivity or allergic reaction to any beta-lactam antibiotic.
✕. Refractory septic shock within 24 hours before screening that does not resolve after 60 minutes of vasopressor therapy.
✕. Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (ULN) for age OR urine output \<0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis. Deterioration of renal function after enrollment during Part B of the study will be handled on a case-by-case basis in discussion with the Medical Monitor.
✕. Evidence of progressively fatal underlying disease, or life expectancy of ≤ 60 days.