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Diagnostic Tests |
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Clinical Trial: Early Diagnosis of Candida Infections in Premature Infants
This study is currently recruiting patients.
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Purpose
This study will: 1) Evaluate new tests for the early and accurate diagnosis of neonatal candidiasis; 2) Evaluate risk factors for neonatal candidiasis so that early treatment can be given safely and effectively.
| Condition | Treatment or Intervention |
|---|---|
| Candidiasis | Device: Beta Glucan Diagnostic Test |
MedlinePlus related topics: Candidiasis
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Early Diagnosis of Neonatal Candidiasis
Secondary Outcomes: Risk factor analysis; Early therapeutic strategies
Expected Total Enrollment: 1750
Study start: March 2004; Expected completion: June 2007
Last follow-up: December 2006; Data entry closure: April 2007
Neonatal candidiasis (infection with candida of the blood, brain, and other vital organs) is common in premature infants; in these infants, it is also often fatal. Diagnosis of candidiasis is challenging and cultures are often negative despite overwhelming disease. This protocol will evaluate several new diagnostic tests for neonatal candidiasis and compare their performance to culture. It will also evaluate strategies for early empirical antifungal therapy.
Eligibility
Ages Eligible for Study: up to 120 Days, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Neonate day of life 3 to day of life 120
- Birthweight <1000 grams
Exclusion Criteria:
- Congenital candidiasis
- Parents do not consent
Location and Contact Information
North Carolina
Duke Unversity, Durham, North Carolina, 27710, United States; Recruiting
Danny Benjamin, MD PhD 919-668-8009 danny.benjamin@duke.edu
Michael Cotten, MD, Principal Investigator
More Information
Record last reviewed: April 2005
Last Updated: April 29, 2005
Record first received: April 28, 2005
ClinicalTrials.gov Identifier: NCT00109525
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005
Resources
- Colonoscopy (National Institute of Diabetes and Digestive and Kidney Diseases)
- Diagnostic Tests (National Institute of Diabetes and Digestive and Kidney Diseases)
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