Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01169402 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)
A Phase 1 study of Fungal Infection and Cardiopulmonary Arrest, sponsored by Michael Cohen-Wolkowiez.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01169402: Completed Phase 1 study of Fungal Infection and Cardiopulmonary Arrest, sponsored by Michael Cohen-Wolkowiez.
NCT01169402 is a Phase 1 study of Fungal Infection and Cardiopulmonary Arrest that has completed, run by Michael Cohen-Wolkowiez. The registered enrollment target is 21 participants, below the 159-participant average among 6 other Fungal Infection trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01169402, a Phase 1 study of Fungal Infection and Cardiopulmonary Arrest, has completed, sponsored by Michael Cohen-Wolkowiez.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper treatment of fungal infections would be difficult if not impossible. The investigators believe that giving prophylactic antifungal medication to all children on ECMO may prevent fungal infections from developing in the first place. Fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. The investigators have obtained FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the study. Blood samples will be collected at specific times around the first and second fluconazole doses to describe the PK and drug extraction by the ECMO circuit.
Primary Outcome
Determine proper dosing of fluconazole in children supported with extracorporeal membrane oxygentation
Conditions Studied
Interventions
- DRUG Fluconazole
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-02-20 |
| Phase | Phase 1 |
What the finished NCT01169402 record still lists
NCT01169402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 159-participant average among 6 other Fungal Infection trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Fungal Infection appearing as the primary indexed condition, and to 1 intervention - of which Fluconazole is the first listed.
NCT01169402 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01169402 about?
NCT01169402 is a clinical study titled "Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)". Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatmen...
What is the current status of trial NCT01169402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-07. Estimated completion is 2013-02-20.
What conditions does trial NCT01169402 study?
This clinical trial studies the following conditions: Fungal Infection, Cardiopulmonary Arrest.
What interventions are being tested in trial NCT01169402?
The interventions under investigation include: Fluconazole (DRUG).
Who is sponsoring clinical trial NCT01169402?
This trial is sponsored by Michael Cohen-Wolkowiez, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01169402 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fungal Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Alternate Day Micafungin: A PK Study in Pediatric Patients
COMPLETED · Phase 1
-
Pharmacogenomics for Better Treatment of Fungal Infections in Cancer
RECRUITING · Phase 2
-
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
ACTIVE NOT RECRUITING · Phase 3
-
Study of Cyclodextrin (SBECD) and Voriconazole Blood Concentrations During Continuous Dialysis
COMPLETED
-
Itraconazole Oral Absorption
COMPLETED · Phase 4
-
CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia