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Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
NCT00734539 · View on ClinicalTrials.gov ↗
Study Summary
The most common etiology of infection-related death or neurodevelopmental impairment in neonates with birthweight \<750 g is invasive candidiasis. Over 70% of the premature neonates who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment. Fluconazole has been commonly used off-label in the neonatal intensive care unit, but definitive recommendations for its use in the nursery have been hampered by the limited number of well-designed trials. In neonates weighing \<750 g, appropriate dosing is not known, definitive safety and long-term follow up trials have not been completed, and there have not been well-powered trials conducted to establish the efficacy of the product using mortality as part of the primary endpoint. Three recent proof-of-concept studies suggest that fluconazole will be safe and effective, and a recently completed pharmacokinetic study is providing data to give preliminary dosing guidance. The next logical step in drug development is proposed by this research: to conduct a pivotal trial to determine the safety and efficacy of fluconazole in premature neonates with 2-year neurodevelopmental follow-up assessment. 362 neonates, with a birthweight \<750g, were randomized at 33 US centers, to twice weekly fluconazole (6 mg/kg) or placebo for the first 6 weeks of life. The primary efficacy endpoint will be Candida-free survival at study day 49. The research will establish definitive dosing, safety, and efficacy of fluconazole; it will also provide critical information on the effects of fluconazole on neurodevelopmental impairment and antifungal resistance. Potential Impact: Approximately 17,000 neonates are born \<750 grams each year in the United States. Over 5000 will die or develop invasive Candida infections. Demonstrating safety and efficacy of fluconazole in preterm neonates will improve the survivability and long term outcomes for these neonates.
Conditions Studied
Interventions
- DRUG placebo
- DRUG fluconazole
Study Locations (20)
Florida
- University of Florida — Gainesville
- Baptist Medical Center — Jacksonville
- Shands Jacksonville Medical Center — Jacksonville
- University of Miami — Miami
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
- Arkansas Childrens Hospital — Little Rock
California
- Children's Hospital of Orange County — Orange
- University of California-San Diego — San Diego
Indiana
- Riley Hospital — Indianapolis
- Memorial Hospital — South Bend
New York
- Brookdale University Medical Center — Brooklyn
- Kings County Hospital Center — Brooklyn
Alabama
- University of Alabama at Birmingham — Birmingham
Kansas
- Wesley Medical Center — Wichita
Kentucky
- Kosair Children's Hospital — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2008-11 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00734539
The ClinicalTrials.gov registry entry for NCT00734539 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daniel Benjamin, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Candidiasis appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00734539 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00734539 about?
NCT00734539 is a clinical study titled "Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight". The most common etiology of infection-related death or neurodevelopmental impairment in neonates with birthweight \<750 g is invasive candidiasis. Over 70% of the premature neonates who develop invasive candidiasis will die or suffer severe, permanent neurologic impairment. Fluconazole has been comm...
What is the current status of trial NCT00734539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 362 participants. The study started on 2008-11. Estimated completion is 2013-04.
What conditions does trial NCT00734539 study?
This clinical trial studies the following conditions: Candidiasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00734539?
The interventions under investigation include: placebo (DRUG), fluconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00734539?
This trial is sponsored by Daniel Benjamin, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00734539 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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