A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA - ND

Phase 1

Conditions: invasive candidiasis, including candidemia (ICC)
MedDRA version: 9.1Level: LLTClassification code 10064954Term: Invasive candidiasis

Registration Number: EUCTR2008-004150-32-IT

Lead Sponsor: PFIZER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Diagnosis of ICC from a blood culture or a culture of a specimen from a normally sterile site taken within 96 hours before study entry. Diagnosis will be based on presence of at least one of the following: Candidemia: at least one blood culture positive for yeast (in the absence of other demonstrated foci of infection) or; Other forms of invasive candidiasis: positive culture for yeast from a specimen from a normally sterile site with or without a positive blood culture; positive yeast culture from a newly-placed drain in a normally sterile site; or any positive blood culture for yeast plus ophthalmic examination consistent with Candida endophthalmitis. NOTE: Positive yeast cultures from sputum (including those obtained by bronchoalveolar lavage or an endotracheal aspirate) will not qualify as a positive culture. AND At least one of the following: A fever defined as an oral/tympanic temperature ≥100.4F (38.0C), rectal temperature ≥101.4F (38.6C) or an axillary temperature ≥99.4F (37.4C); Hypothermia defined as a temperature less than 96.8F (36.0C); A systolic blood pressure of less than 100% for age and gender norms (per National High Blood Pressure Education Program (NHBPEP) Working Group on Children and Adolescents guidelines5); Signs or symptoms of candidemia/invasive candidiasis which may include the following: feeding intolerance, bloody stools, abdominal distension, thrombocytopenia, lethargy, color change, hyperglycemia, glycosuria, unexplained metabolic acidosis.2. Male or female between the ages of 1 month and <18 years. Females of childbearing potential must have adequate contraception as determined by the Investigator for the duration of the trial. 3. For each subject, parent or legal guardian must be willing and able to provide signed and dated written informed consent documentation. Assent from the child or adolescent will be obtained as appropriate. This is to be obtained prior to enrollment. 4. Will be available for the duration of the study and be able to abide by the study restrictions.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Premature neonates born at gestation of less than 36 weeks (unless the sum of gestational age plus chronological age is at least 44 weeks). Note: Rounding to the closest week is round up one week if birth occurred on days 4 to 6 of the week and round down one week if birth occurred on days 1 to 3 of the week. 2. Known history of allergy, hypersensitivity or serious reaction to echinocandin antifungals. 3. Female subjects who are pregnant or lactating, or planning a pregnancy during the course of the study. 4. Subjects who have received more than 48 hours of systemic antifungal therapy for the Candida infection for which their enrollment is being considered. 5. Subjects who have failed antifungal therapy with any systemic antifungal for this episode of candidiasis/candidemia. Recurrence within 2 weeks is considered failure of previous therapy. 6. Subjects with any of the following abnormal laboratory values: Total bilirubin, AST or ALT >5 times the upper limit of normal (ULN). 7. Subjects who require continued treatment with another systemic antifungal agent [oral nonabsorbable azoles (eg, clotrimazole troches) will be permitted]. Exception: the first 6 subjects enrolled who are between 1 month to <2 years of age may receive a second systemic antifungal agent at the investigator?s discretion. 8. Subjects with poor venous access that would preclude IV drug delivery or multiple blood draws.9. Subjects who have participated in a study of an investigational drug or device (without any FDA and EMEA approved indications) within four weeks of study entry. The investigational use of licensed agents are permitted if the subject is on a stable regimen for four weeks prior to study start, and expected to remain on the stable regimen for the duration of the trial. 10. Life expectancy <72 hours. 11. Subjects with suspected Candida osteomyelitis, endocarditis, or meningitis. 12. Subjects with prosthetic devices at a suspected site of infection are to be excluded, unless the device is removed at study entry. [Hemodialysis shunts (AV fistulae) may remain in situ).] 13. Subjects with a prosthetic heart valve or vascular graft suspected to be the site of the Candida infection and positive blood cultures. 14. Other severe acute or chronic medical or psychiatric condition, electrocardiogram (ECG) abnormalities, 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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