Clinical Trials Logo
  1. Home
  2. Candidemia
  3. NCT00761267

Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

Candidemia Clinical Trial

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

Clinical Trial Summary

Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - <18 years) with invasive candidiasis, including candidemia (ICC).

Clinical Trial Description

Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - < 18 years) with invasive candidiasis, including candidemia (ICC). To participate in the study, at the time of enrollment subjects must (1) have either a confirmed diagnosis of ICC or mycological evidence highly suggestive of Candida sp or (2) in infants 1 month to < 2 years only, be at high risk of candidiasis. All subjects meeting screening criteria receive IV anidulafungin. Subjects will be stratified by age (1 month - < 2 years; 2 years - < 5 years; 5 years - < 18 years). Subjects may be switched to oral fluconazole, provided that the pre-specified criteria are met. Subjects with microbiologically confirmed ICC must have a minimum total treatment duration of 14 days. The maximum allowed treatment duration of anidulafungin is 35 days; the maximum total treatment duration for the study is 49 days. At selected centers, anidulafungin pharmacokinetics will be assessed in the first 6 subjects age 1 month - < 2 years to confirm the recommended dosage regimen. A population PK-PD analysis will be performed in all other enrolled subjects. Subjects will be followed for safety through 6 week FU visit. Efficacy for subjects with confirmed ICC will be assessed at EOIVT, EOT, 2-week FU and 6-week FU visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00761267
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 3
Start date February 2009
Completion date February 2018
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01982071 - A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia Phase 4
Completed NCT02244606 - Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis Phase 2
Completed NCT02163889 - Serial Therapeutic and Antifungal Monitoring Protocol
Recruiting NCT01438216 - Anidulafungin Pharmacokinetics in Intensive Care Unit Patients N/A
Not yet recruiting NCT01249313 - Risk Factor and Outcome of Candidemia N/A
Terminated NCT01213823 - Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins Phase 4
Completed NCT00940017 - A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects Phase 4
Completed NCT00105144 - Study of Micafungin in Patients With Invasive Candidiasis or Candidemia Phase 3
Completed NCT03667690 - Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis Phase 3
Completed NCT03604705 - An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia Phase 2
Completed NCT00607763 - Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug Phase 1
Completed NCT00608335 - Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug Phase 1
Recruiting NCT04147975 - Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood
Completed NCT01734525 - Negative Beta Glucan in ICU Patients Phase 4
Withdrawn NCT01622595 - UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients N/A
Completed NCT03363841 - Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) Phase 3
Completed NCT03799172 - Echinocandins Versus Azoles for Candidemia Treatment
Completed NCT01406093 - Early- and Late-onset Candidemia N/A
Completed NCT00670657 - CRITIC - Treatment of Candidemia and Invasive Candidiasis Phase 4
Completed NCT00113191 - Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants N/A