Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
NCT00292071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2017-02-23
Summary
This is an open-label study of MK0991 in children between 3 to 24 months of age with new onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of caspofungin.
Conditions
Interventions
- DRUG
-
caspofungin acetate
(50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Months
- Max Age
- 24 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-05-31
- Primary Completion
- 2006-07-31
- Completion
- 2006-07-31
More Related Trials
-
Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)
NCT00548080 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
NCT01945281 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
NCT02452034 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
NCT01165320 ·Status: COMPLETED ·Phase: PHASE2
-
Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
NCT00082524 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
NCT00056381 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia
NCT00001790 ·Status: COMPLETED ·Phase: PHASE1
-
Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
NCT00008359 ·Status: COMPLETED ·Phase: PHASE3
-
Caspofungin for the Treatment of Non-blood Candida Infections (0991-045)
NCT00083343 ·Status: COMPLETED ·Phase: PHASE2
-
A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis
NCT02057289 ·Status: TERMINATED ·Phase: PHASE1
-
Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis
NCT01318148 ·Status: COMPLETED ·Phase: PHASE2
-
A 28 - 90 Days Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Injection as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia (0991-053)(COMPLETED)
NCT00379964 ·Status: COMPLETED ·Phase: PHASE3
-
PK/PD of Caspofungin in Children Severe Infection
NCT04961593 ·Status: RECRUITING
-
A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
NCT00717860 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates
NCT01533558 ·Status: COMPLETED
-
Pharmacokinetics and Pharmacodynamics of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit
NCT02510053 ·Status: UNKNOWN ·Phase: NA
-
Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation
NCT01666769 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy
NCT02895529 ·Status: TERMINATED ·Phase: PHASE4
-
Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
NCT03421002 ·Status: COMPLETED ·Phase: PHASE2
-
MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037)
NCT00076869 ·Status: COMPLETED ·Phase: PHASE2
-
Alternate Day Micafungin: A PK Study in Pediatric Patients
NCT00842504 ·Status: COMPLETED ·Phase: PHASE1
-
Caspofungin Study for Fungal Infections in Adults in Critical Care Settings
NCT00095316 ·Status: TERMINATED ·Phase: PHASE3
-
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
NCT04218851 ·Status: COMPLETED ·Phase: PHASE2
-
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
NCT00761267 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics of Fluconazole in Children (2-18 Years)
NCT05130723 ·Status: UNKNOWN