None listed
Conditions
Interventions
Anidulafungin Type of group
Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis
followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Maximum treatment duration with anidulafungin is 35 days. Subjects may be switched to oral fluconazole [6-12 mg/kg/day (not to ex
Sponsors
PFIZER S.A.,
Eligibility
Sex/Gender
All
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of CIC from a blood culture or a culture of a sample from a normally sterile site obtained within 96 hours prior to entering the study. • Subjects of both sexes from 1 month to <18 years of age. Patients of childbearing age should use appropriate contraceptive methods, as directed by the researcher, throughout the trial. • For each subject, their parents or legal guardian must be willing and able to give informed consent in writing signed and dated. The consent of the child or adolescent will be obtained when appropriate. It will be obtained before recruitment. • Will be available throughout the study and can withstand the restrictions of the study.
Exclusion criteria
Exclusion criteria: • Premature infants born before 36 weeks of gestation (unless the sum of the gestational age plus the chronological age is at least 44 weeks). • Known history of hypersensitivity allergy or severe reaction to echinocandins. • Girls who are pregnant or breastfeeding, or who expect to become pregnant during the study, • Subjects who have received more than 4.8.hom? Of systemic antifungal treatment for Candida infection considering their inclusion in the study. • Subjects who have not responded to antifungal treatment with any systemic antifungal for this episode of candidiasis / candidemia. Recurrence in the following two weeks is considered a failure of previous treatment. • Subjects presenting any of the following anomalies in analytical parameters: Total bilirubin, AST or ALT> 5 times greater than the upper limit of normal • Subjects that require continuation of treatment with another systemic antifungal (non-absorbable oral azoles will be allowed [such as clotrimazole]). Exception: the first six subjects recruited between 1 month and <2 years of age may receive a second systemic antifungal at the discretion of the investigator. • Subjects with poor venous access that would prevent intravenous administration of a drug or the collection of several blood samples. • Patients who have participated in a study of a drug or device under investigation (without indications approved by the FDA and the EMEA) in the four weeks prior to the study. Experimental use of approved drugs is allowed if the subject has received a stable pattern for four weeks before entering the study and is expected to maintain that stable pattern throughout the study. • Life expectancy <72 hours; • Subjects with suspected osteomyelitis, endocarditis or candidiasic meningitis. • Subjects who have prostheses in a suspected infection site will be excluded, unless the device is removed at the entrance to the study. (Hemodialysis shunts [AV fistulas] may remain in place. • Subjects with a heart valve prosthesis or vascular graft that are suspected to be the focus of Candida infection and positive blood cultures. • Any other serious, acute or chronic medical or psychiatric disorder, electrocardiogram abnormalities (ECG) or any laboratory abnormality that may increase the risk associated with participation in the study or administration of the product under investigation or interfere with the interpretation of the results of the study and, in the opinion of the researcher, prevent participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral). Measure:Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Timepoints:Baseline up to 6 weeks after EOT (up to 91 days) ; Outcome name:Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: ) 1.5*upper limit of normal (ULN); Platelets: 1.75*ULN; white blood cell count: 1.5*ULN; neutrophils (absolute or percent): 1.2*ULN; basophils (absolute or percent): >1.2*ULN; lymphocytes (absolute or percent): 1.2*ULN; monocytes (absolute or percent): >1.2*ULN. Serum Chemistry parameters: sodium: 1.05*ULN, potassium, chloride, bicarbonate, calcium: 1.1*ULN; magnesium: >1.1*ULN or 1.3* ULN, creatinine: >1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : >3.0*ULN ; total bilirubin: >1.5*ULN; albumin: 1.2*ULN and glucose: 1.5*ULN.EOT visit defined as last day of study treatment (IV or oral). Measure:Number of Participants With Laboratory Abnormalities Timepoints:Baseline up to 6 weeks after EOT (up to 91 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection[CI]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral). Measure:Number of Participants With Global Response Timepoints:End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) ; Outcome name:Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from participants in the PK sub-study. AUC24 was calculated based on the trapezoidal rule. Measure:Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup Timepoints:Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion ; Outcome name:Cmax was obtained directly from the observed concentration data on Day 2. Measure:Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup Tim | — |
Countries
France, Germany, Greece, Italy, Peru, Portugal, Spain, United Kindgdom
Outcome results
None listed