| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02497781 | Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs) | PHASE2 | COMPLETED | 97 | — | — | Sep 24, 2015 | Sep 15, 2017 | Jul 11, 2018 | 28 | United States, Czechia +7 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 36 days after last dose of study treatment \[IV or oral\]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.
Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of diarrhea, renal disorder, hematological disorder and liver disorder relevant to the cephalosporin class within the safety topics (ST) based on MedDRA 20.0) were reported in this outcome measure.
EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Criteria for potentially clinically significant laboratory abnormalities: hematology (platelets: \<0.4\*lower limit of normal \[LLN\], \>2\*upper limit of normal \[ULN\], \>40% decrease from baseline \[DFB\],\>100% Increase from baseline \[IFB\]; Chemistry (Bicarbonate: \<0.7\*LLN, \>1.3\*ULN, \>50% DFB, \>30% IFB).
PCS criteria for abnormal value of ECG parameters: QT interval \>=450 milliseconds (msec); 480 msec; \>=500 msec; Increase from baseline (IFB) of \>=30 msec; \>=60 msec and \>90 msec; Decrease from baseline (DFB) of \>=30 msec; \>=60 msec and \>90 msec. QT interval using Bazett's correction (QTcB): \>=450 milliseconds (msec); 480 msec; \>=500 msec; Increase from baseline (IFB) of \>=30 msec; \>=60 msec and \>90 msec; DFB of \>=30 msec; \>=60 msec and \>90 msec. QT interval using Fridericia's correction (QTcF): \>=450 msec; 480 msec; \>=500 msec; IFB of \>=30 msec; \>=60 msec and \>90 msec; DFB of \>=30 msec; \>=60 msec and \>90 msec. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: \<30 mL/min/1.73 m\^2, \>=30 to \<50 mL/min/1.73 m\^2, \>=50 mL/min/1.73 m\^2 to \<80 mL/min/1.73 m\^2, and \>=80 mL/min/1.73 m\^2.
CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: \<30 mL/min/1.73 m\^2, \>=30 to \<50 mL/min/1.73 m\^2, \>=50 mL/min/1.73 m\^2 to \<80 mL/min/1.73 m\^2, and \>=80 mL/min/1.73 m\^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: \<30 mL/min/1.73 m\^2, \>=30 to \<50 mL/min/1.73 m\^2, \>=50 mL/min/1.73 m\^2 to \<80 mL/min/1.73 m\^2, and \>=80 mL/min/1.73 m\^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).
| Arm | Type | Description |
|---|---|---|
| ceftazidime-avibactam (CAZ-AVI) | EXPERIMENTAL | CAZ-AVI to be administered every 8 hours as a 2-hour infusion (CAZ-AVI dose and frequency of IV administration will depend upon body weight and renal function) |
| Cefepime | ACTIVE_COMPARATOR | Patients randomised to receive cefepime should receive the dose, schedule and infusion duration as recommended in the local prescribing information or as prescribed by the investigator. The maximum dose of cefepime in any single infusion should not exceed 2000 mg |
| Name | Type | Description |
|---|---|---|
| Ceftazidime -avibactam | DRUG | Patients randomised (3:1) to the CAZ-AVI or cefepime treatment |
| Cefepime | DRUG | Patients randomised (3:1) to the CAZ-AVI or cefepime treatment |
Inclusion Criteria: 1. Must be ≥3 calendar months to \<18 years of age. Patients aged ≥3 calendar months to \<1 year must have been born at term (defined as gestational age ≥37 weeks). 2. Written informed consent from parent(s) or other legally acceptable representative(s), and informed assent from...