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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00109525
Other study ID # NICHD-NRN-0030
Secondary ID UL1RR024139UL1RR
Status Completed
Phase
First received
Last updated
Start date March 2004
Est. completion date December 2009

Study information

Verified date March 2019
Source NICHD Neonatal Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date December 2009
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 120 Days
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Emory University Atlanta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Tufts Medical Center Boston Massachusetts
United States Wake Forest University Charlotte North Carolina
United States Cincinnati Children's Medical Center Cincinnati Ohio
United States Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States Wayne State University Detroit Michigan
United States Duke University Durham North Carolina
United States RTI International Durham North Carolina
United States University of Texas Health Science Center at Houston Houston Texas
United States Indiana University Indianapolis Indiana
United States University of Iowa Iowa City Iowa
United States University of Miami Miami Florida
United States Yale University New Haven Connecticut
United States Stanford University Palo Alto California
United States Brown University, Women & Infants Hospital of Rhode Island Providence Rhode Island
United States University of Rochester Rochester New York
United States University of California at San Diego San Diego California

Sponsors (3)

Lead Sponsor Collaborator
NICHD Neonatal Research Network Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Adams-Chapman I, Bann CM, Das A, Goldberg RN, Stoll BJ, Walsh MC, Sánchez 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 B — View Citation

Benjamin DK Jr, Stoll BJ, Gantz MG, Walsh MC, Sánchez 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, Be — View Citation

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. Candi — View Citation

Greenberg RG, Benjamin DK Jr, Gantz MG, Cotten CM, Stoll BJ, Walsh MC, Sánchez 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, — View Citation

Wynn JL, Tan S, Gantz MG, Das A, Goldberg RN, Adams-Chapman I, Stoll BJ, Shankaran S, Walsh MC, Auten KJ, Miller NA, Sánchez PJ, Higgins RD, Cotten CM, Smith PB, Benjamin DK Jr; NICHD Neonatal Research Network. Outcomes following candiduria in extremely l — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Probability of invasive candidiasis based on new assay results Until discharge
Primary Determine test performance of clinical predictive model Until discharge
Secondary Determine test performance (sensitivity and specificity) of polymerase chain reaction (PCR) testing Until discharge
Secondary Determine test performance of Beta-glucan assay Until discharge
Secondary Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of blood samples Until discharge
Secondary Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of urine samples Until discharge
Secondary Determine test performance of the blood culture Until discharge
Secondary Determine test performance of the lumbar puncture (cell count, protein, glucose, and culture) Until discharge
Secondary Determine test performance of tracheal aspirates Until discharge
Secondary Determine test performance of urine cultures Until discharge
Secondary Compare clinical predictive model performance to neonatologist clinical judgment Until discharge
Secondary Determine incidence of end-organ damage in neonates with candidemia Until discharge
Secondary Determine resistance patterns of organisms isolated Until discharge
Secondary Determine molecular epidemiology of candidemia Until discharge
Secondary Determine genetic expression of organism virulence factors Until discharge
Secondary Neurodevelopmental outcome 18-22 months corrected age
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