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Completed No phase listed Observational Accepts healthy volunteers

Early Diagnosis of Candidiasis in Premature Infants

ClinicalTrials.gov ID: NCT00109525

Public ClinicalTrials.gov record NCT00109525. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 10:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Early Diagnosis of Nosocomial Candidiasis Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately. 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth weights ≤1,000g; 100 of these infants later tested positive for candidiasis. Blood, urine, and lumbar puncture samples were collected whenever other specimens were obtained from participants for cultures. These samples are being tested using the new methods and compared with standard culture results. Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age.

Study identification

NCT ID
NCT00109525
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
1,500 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Days to 120 Days
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2004 (Type not available)
Primary completion
Jul 2007 (Actual)
Completion
Dec 2009 (Actual)
Last update posted
Mar 22, 2019

2004 – 2009

United States locations

U.S. sites
20
U.S. states
15
U.S. cities
19
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
Stanford University Palo Alto California 94304 —
University of California at San Diego San Diego California 92103-8774 —
Yale University New Haven Connecticut 06504 —
University of Miami Miami Florida 33136 —
Emory University Atlanta Georgia 30303 —
Indiana University Indianapolis Indiana 46202 —
University of Iowa Iowa City Iowa 52242 —
Tufts Medical Center Boston Massachusetts 02111 —
Wayne State University Detroit Michigan 48201 —
University of New Mexico Albuquerque New Mexico 87131 —
University of Rochester Rochester New York 14642 —
Wake Forest University Charlotte North Carolina 27157 —
RTI International Durham North Carolina 27705 —
Duke University Durham North Carolina 27710 —
Cincinnati Children's Medical Center Cincinnati Ohio 45267 —
Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio 44106 —
Brown University, Women & Infants Hospital of Rhode Island Providence Rhode Island 02905 —
University of Texas Southwestern Medical Center at Dallas Dallas Texas 75235 —
University of Texas Health Science Center at Houston Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00109525, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 22, 2019 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00109525 live on ClinicalTrials.gov.

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