None listed
Conditions
Interventions
Group 1 Type of group
Infants will receive a daily intravenous administration of micafungin over 2 hours. The dose of micafungin will be 10 mg / kg.
Group name:Group 2 Type of group
Infants will receive a daily intravenous administration of CAB over 2 hours. The dose of CAB will be 1 mg / kg.
Sponsors
Astellas Pharma US, Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: • Prior to admission, informed written consent of the legally authorized representative and authorization under HIPAA for centers in the US must be obtained. UU. or the equivalent privacy language in accordance with national standards. • Infants must be between 48 hours of life and 120 days of life at the time of obtaining the crop. • Diagnosis of invasive candidiasis • The infant must have sufficient venous access to allow the administration of the study medication and the monitoring of the safety variables.
Exclusion criteria
Exclusion criteria: • Infants with a history of any hypersensitivity reaction or severe vasomotor reaction to any echinocandin or systemic product with amphotericin B. • Infants who have received more than 48 hours of systemic antifungal treatment before the first dose of the study drug for the treatment of current Candida infection. Cumulative doses should not exceed 2 mg / kg of CAB. In the case of a systemic antifungal treatment not specified here, infants who have received more than 2 therapeutic doses within 48 hours prior to the first dose of the study drug will not be eligible. • Infants who have a regrowth of systemic mycosis while receiving a product with amphotericin B or an echinocandin as a prophylaxis. • Infants who have failed previous antifungal treatment for this episode of invasive candidiasis, including recurrence of the same Candida infection within 2 weeks of the end of antifungal treatment. • Infants with a concomitant medical condition, whose participation, in the opinion of the researcher and / or the medical advisor, may create an additional unacceptable risk. • Infants enrolled previously in this study. • Infants coinfected with a fungal organism not belonging to the genus Candida. • Infants whose positive cultures of yeast fungi have been obtained exclusively from a permanent catheter in the bladder or sputum.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Mycosis-free survival is defined as eradication (free from mycosis) and alive one week after the last dose of the study drug without the need for alternative systemic antifungal treatment as a continuation of treatment. Measure:Mycosis-free survival one week after the last dose of the study drug Timepoints:1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Absence documented by culture or histology of infectious species of the genus Candida obtained from all positive places normally sterile, confirmed with two negative samples, obtained at least 24 hours apart; in the case of Candida meningitis and / or candiduria, a negative culture. If the result of the culture does not show fungal growth within 72 hours of obtaining, for the purpose of determining eradication, the culture may be considered negative. Measure:Time elapsed until mycological elimination of invasive candidiasis. Timepoints:During the study ; Outcome name:After positive cultures obtained from normally sterile places (eg, blood, urine or CSF) to detect Candida, dissemination in the affected organ should be evaluated as follows: Abdominal ultrasound v / o computed tomography, echocardiogram, head ultrasound, ophthalmoscopy. Measure:Survival without mycosis in patients with dissemination in the affected organ at the end of treatment with the study drug and one week after the last dose of the study drug Timepoints:During the study ; Outcome name:Emerging mycosis: Invasive mycosis detected at any time during the study by an organism that is not of the Candida genus, or An invasive mycosis detected during the period of treatment or post-treatment with an identified species of Candida in addition to those detected at the baseline level. If it occurs within 72 hours of the first dose of the study drug, the infection will be considered part of the final diagnosis of the infection at the time of enrollment and not as an emerging infection. Recurrent Mycosis: A systemic mycosis in an infant with eradication at the end of treatment with the study drug that develops positive blood cultures or a deep mycologically confirmed Candida infection, with the same species as the infection at the time of enrollment Measure:General incidence of emerging and recurrent mycoses until the end of the study Timepoints:During the | — |
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed