- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00109525
Early Diagnosis of Candidiasis in Premature Infants (Candida)
Early Diagnosis of Nosocomial Candidiasis Study
Study Overview
Status
Detailed Description
Candida species are a leading cause of infectious mortality in newborns with the incidence rates estimated at 4-18% in extremely low birth weight (ELBW) infants. 20-30% of these infants are likely to die. Because candida can invade virtually all body tissues (eyes, brain, heart, lung, liver, spleen, urinary tract, and joints), survivors of invasive Candida infections are at risk of blindness, developmental delays, and the need for surgical and other corrective procedures.
Time is of the essence in detecting and treating these infections, with infant mortality from candidiasis largely attributed to duration of time for cultures to become positive for Candida. Diagnosis of candidiasis is challenging - blood and urine tests are slow (taking up to 72 hours to complete) and inaccurate in many cases, showing negative results despite overwhelming disease in adults as well as children. These problems are likely made worse in neonates, with smaller amounts of blood available for testing and infections that often spread to tissues inaccessible for testing.
This observational study is evaluating the performance of new lab tests (beta-glucan assays, Gas Chromatography Mass Spectrometry for D-arabinitol, and polymerase chain reaction tests) compared to existing culture tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately.
In this study, 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth weights ≤1,000g by 72 hours of life; more than 100 of these infants later tested positive for candidiasis. In the larger cohort, whenever cultures of blood or urine were obtained, or a lumbar puncture was done, additional samples and clinical data were collected. These additional samples are being tested using the new techniques under investigation. No additional blood specimens were taken once participants had a positive blood culture for candida. Note: Test procedure reagents are being provided the Duke University laboratory by Cape Cod Incorporated and Rockeby; the Thrasher Research Fund is also providing support to the Duke University laboratory.
Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age to evaluate potential early risk factors with long-term outcome.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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California
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Palo Alto, California, United States, 94304
- Stanford University
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San Diego, California, United States, 92103-8774
- University of California at San Diego
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Connecticut
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New Haven, Connecticut, United States, 06504
- Yale University
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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North Carolina
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Charlotte, North Carolina, United States, 27157
- Wake Forest University
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Durham, North Carolina, United States, 27710
- Duke University
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Durham, North Carolina, United States, 27705
- RTI International
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Ohio
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Cincinnati, Ohio, United States, 45267
- Cincinnati Children's Medical Center
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University, Rainbow Babies and Children's Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Brown University, Women & Infants Hospital of Rhode Island
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Texas
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Dallas, Texas, United States, 75235
- University of Texas Southwestern Medical Center at Dallas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Infants born ≤1,000g birth weight
- Infants >72 hours old and less than 120 days old
Exclusion Criteria:
- Prior positive blood culture for Candida
- Evidence of congenital candidiasis
- Parents/legal guardians refuse consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Probability of invasive candidiasis based on new assay results
Time Frame: Until discharge
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Until discharge
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Determine test performance of clinical predictive model
Time Frame: Until discharge
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Until discharge
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine test performance (sensitivity and specificity) of polymerase chain reaction (PCR) testing
Time Frame: Until discharge
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Until discharge
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Determine test performance of Beta-glucan assay
Time Frame: Until discharge
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Until discharge
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Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of blood samples
Time Frame: Until discharge
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Until discharge
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Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of urine samples
Time Frame: Until discharge
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Until discharge
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Determine test performance of the blood culture
Time Frame: Until discharge
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Until discharge
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Determine test performance of the lumbar puncture (cell count, protein, glucose, and culture)
Time Frame: Until discharge
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Until discharge
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Determine test performance of tracheal aspirates
Time Frame: Until discharge
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Until discharge
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Determine test performance of urine cultures
Time Frame: Until discharge
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Until discharge
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Compare clinical predictive model performance to neonatologist clinical judgment
Time Frame: Until discharge
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Until discharge
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Determine incidence of end-organ damage in neonates with candidemia
Time Frame: Until discharge
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Until discharge
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Determine resistance patterns of organisms isolated
Time Frame: Until discharge
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Until discharge
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Determine molecular epidemiology of candidemia
Time Frame: Until discharge
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Until discharge
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Determine genetic expression of organism virulence factors
Time Frame: Until discharge
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Until discharge
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Neurodevelopmental outcome
Time Frame: 18-22 months corrected age
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18-22 months corrected age
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shahnaz Duara, MD, University of Miami
Publications and helpful links
General Publications
- Benjamin DK Jr, Stoll BJ, Gantz MG, Walsh MC, Sanchez PJ, Das A, Shankaran S, Higgins RD, Auten KJ, Miller NA, Walsh TJ, Laptook AR, Carlo WA, Kennedy KA, Finer NN, Duara S, Schibler K, Chapman RL, Van Meurs KP, Frantz ID 3rd, Phelps DL, Poindexter BB, Bell EF, O'Shea TM, Watterberg KL, Goldberg RN; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal candidiasis: epidemiology, risk factors, and clinical judgment. Pediatrics. 2010 Oct;126(4):e865-73. doi: 10.1542/peds.2009-3412. Epub 2010 Sep 27.
- Adams-Chapman I, Bann CM, Das A, Goldberg RN, Stoll BJ, Walsh MC, Sanchez PJ, Higgins RD, Shankaran S, Watterberg KL, Duara S, Miller NA, Heyne RJ, Peralta-Carcelen M, Goldstein RF, Steichen JJ, Bauer CR, Hintz SR, Evans PW, Acarregui MJ, Myers GJ, Vohr BR, Wilson-Costello DE, Pappas A, Vaucher YE, Ehrenkranz RA, McGowan EC, Dillard RG, Fuller J, Benjamin DK Jr; Eunice Kennedy Shriver National Institutes of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome of extremely low birth weight infants with Candida infection. J Pediatr. 2013 Oct;163(4):961-7.e3. doi: 10.1016/j.jpeds.2013.04.034. Epub 2013 May 30.
- Bliss JM, Wong AY, Bhak G, Laforce-Nesbitt SS, Taylor S, Tan S, Stoll BJ, Higgins RD, Shankaran S, Benjamin DK Jr; Candida Subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Candida virulence properties and adverse clinical outcomes in neonatal candidiasis. J Pediatr. 2012 Sep;161(3):441-447.e2. doi: 10.1016/j.jpeds.2012.02.051. Epub 2012 Apr 14.
- Greenberg RG, Benjamin DK Jr, Gantz MG, Cotten CM, Stoll BJ, Walsh MC, Sanchez PJ, Shankaran S, Das A, Higgins RD, Miller NA, Auten KJ, Walsh TJ, Laptook AR, Carlo WA, Kennedy KA, Finer NN, Duara S, Schibler K, Ehrenkranz RA, Van Meurs KP, Frantz ID 3rd, Phelps DL, Poindexter BB, Bell EF, O'Shea TM, Watterberg KL, Goldberg RN, Smith PB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Empiric antifungal therapy and outcomes in extremely low birth weight infants with invasive candidiasis. J Pediatr. 2012 Aug;161(2):264-9.e2. doi: 10.1016/j.jpeds.2012.01.053. Epub 2012 Mar 15.
- Wynn JL, Tan S, Gantz MG, Das A, Goldberg RN, Adams-Chapman I, Stoll BJ, Shankaran S, Walsh MC, Auten KJ, Miller NA, Sanchez PJ, Higgins RD, Cotten CM, Smith PB, Benjamin DK Jr; NICHD Neonatal Research Network. Outcomes following candiduria in extremely low birth weight infants. Clin Infect Dis. 2012 Feb 1;54(3):331-9. doi: 10.1093/cid/cir800. Epub 2011 Dec 5.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NICHD-NRN-0030
- M01RR000633 (U.S. NIH Grant/Contract)
- U10HD036790 (U.S. NIH Grant/Contract)
- U10HD021364 (U.S. NIH Grant/Contract)
- U10HD021373 (U.S. NIH Grant/Contract)
- U10HD021385 (U.S. NIH Grant/Contract)
- U10HD027851 (U.S. NIH Grant/Contract)
- U10HD027853 (U.S. NIH Grant/Contract)
- U10HD027856 (U.S. NIH Grant/Contract)
- U10HD027871 (U.S. NIH Grant/Contract)
- U10HD027880 (U.S. NIH Grant/Contract)
- U10HD027904 (U.S. NIH Grant/Contract)
- U10HD034216 (U.S. NIH Grant/Contract)
- U10HD040492 (U.S. NIH Grant/Contract)
- U10HD040689 (U.S. NIH Grant/Contract)
- U10HD053089 (U.S. NIH Grant/Contract)
- U10HD053109 (U.S. NIH Grant/Contract)
- U10HD053119 (U.S. NIH Grant/Contract)
- UL1RR024139 (U.S. NIH Grant/Contract)
- M01RR000059 (U.S. NIH Grant/Contract)
- M01RR008084 (U.S. NIH Grant/Contract)
- M01RR006022 (U.S. NIH Grant/Contract)
- M01RR000750 (U.S. NIH Grant/Contract)
- M01RR000070 (U.S. NIH Grant/Contract)
- M01RR000997 (U.S. NIH Grant/Contract)
- U10HD021397 (U.S. NIH Grant/Contract)
- U10HD040461 (U.S. NIH Grant/Contract)
- U10HD040498 (U.S. NIH Grant/Contract)
- U10HD040521 (U.S. NIH Grant/Contract)
- M01RR000032 (U.S. NIH Grant/Contract)
- M01RR000039 (U.S. NIH Grant/Contract)
- M01RR000044 (U.S. NIH Grant/Contract)
- M01RR000054 (U.S. NIH Grant/Contract)
- M01RR000080 (U.S. NIH Grant/Contract)
- M01RR007122 (U.S. NIH Grant/Contract)
- M01RR016587 (U.S. NIH Grant/Contract)
- M01RR000030 (U.S. NIH Grant/Contract)
- UL1RR024160 (U.S. NIH Grant/Contract)
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