Study To Assess The Safety, Pharmacokinetics, And Evaluate The Response To Anidulafungin When Treating Children With Invasive Candidiasis.
- Conditions
- INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIAMedDRA version: 14.0Level: LLTClassification code 10064954Term: Invasive candidiasisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2008-004150-32-DE
- Lead Sponsor
- Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Subject eligibility should be reviewed and documented by an appropriate qualified member of the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Definitive diagnosis of invasive candidiasis/candidemia (ICC) is based on the growth of Candida sp. from a blood and/or tissue culture obtained from a normally sterile site.
For the purpose of study entry, a subject must have at least one microbiologic AND at least one clinical criteria listed below.
Microbiologic Criteria:
Subject must have at least one of the criteria listed below either at the time of study entry or within 96 hours prior to study entry.
? Candidemia: At least one blood culture positive for Candida sp. (in the absence of other demonstrated foci of infection) or;
? Other forms of invasive candidiasis:
? Positive culture for Candida sp. from a specimen from a normally sterile site (other than blood), with or without a positive blood culture;
? Positive culture for Candida sp. from a percutaneous drain (eg, chest tube, intra-abdominal) placed <24 hours in a normally sterile site;
? Positive blood culture for Candida sp. plus ophthalmic examination consistent with Candida endophthalmitis;
? Candida endocarditis: At least one positive blood culture for Candida sp. and evidence of endocarditis on echocardiogram;
? Candida osteomyelitis: At least one positive culture for Candida sp. from a bone biopsy or aspirate and evidence of osteomyelitis on a magnetic resonance imaging (MRI) study;
Clinical Criteria:
Subject must have at least one of the criteria listed below either at the time of study entry or within 96 hours prior to study entry.
? Fever, defined as an oral/tympanic temperature =100.4°F (38.0oC), rectal temperature =101.4oF (38.6oC) or an axillary temperature =99.4oF (37.4oC);
? Hypothermia, defined as a temperature less than 96.8°F (36.0oC);
? Hypotension, defined as 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 guidelines);7
? Other 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.
** Important Notes **
Subjects may be enrolled in the study on the basis of mycologic evidence highly suggestive of Candida sp. (eg, the growth of yeast in culture and/or the direct microscopic visualization of yeast, hyphae, or pseudohyphae) from a sample obtained from a normally sterile site (eg, blood and/or tissue). However, in these subjects, culture confirmation of Candida sp. must be obtained within 96 hours post treatment
initiation. If culture confirmation is not obtained within this time period, subjects will be discontinued from study treatment but will remain in the study for continued safety monitoring. These subject will be required to return for the 2-week and 6-week follow-up visits.
Positive cultures for Candida sp. from urine (in the absence of clinical signs and symptoms of pyelonephritis), sputum, bronchoalveolar lavage (BAL), endotracheal aspiration, gastric drainage or gastric aspiration do not qualify as a positive culture for study entry.
2. Male or female between the ages of 1 month and <18 years. Females
Subjects presenting with any of the following will not be included in the study:
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 intolerance, allergy, hypersensitivity or serious reaction to anidulafungin or any of its excipients (including fructose), or to other 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.
** Important Note ** Prior antifungal prophylaxis (ie, the use of an antifungal agent for the prevention of fungal infection) is allowed.
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 meningitis.
12. Subjects with a prosthetic device and/or vascular catheter (including central venous catheter or an implantable port) at a suspected site of infection are to be excluded, unless the device is removed at study entry or soon after randomization (within 24 – 48 hours).
** Important Note ** If it is anticipated that a prosthetic device or vascular catheter cannot be removed within this time frame, the medical monitor should be contacted to discuss enrolment.
13. Subjects with a vascular graft suspected to be the site of the Candida infection and positive blood cultures.
14. Subjects with prosthetic or native valve Candida endocarditis who have not and/or cannot undergo valvular replacement surgery prior to or soon after study entry.
15. Subjects with Candida osteomyelitis associated with a prosthetic device in whom the prosthetic device has not been and/or cannot be removed surgically prior to or soon after study entry.
16. 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
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