Early Diagnosis of Candidiasis in Premature Infants

NCT00109525 | Completed

• 38 other identifiers: NICHD-NRN-0030UL1RR024139UL1RR024160M01RR016587M01RR000030M01RR000032M01RR000039M01RR000044M01RR000054M01RR000059M01RR006022M01RR000633M01RR000070M01RR007122M01RR000750M01RR000080M01RR008084M01RR000997U10HD036790U10HD021364U10HD021373U10HD021385U10HD021397U10HD027851U10HD027853U10HD027856U10HD027871U10HD027880U10HD027904U10HD034216U10HD040461U10HD040492U10HD040498U10HD040521U10HD040689U10HD053089U10HD053109U10HD053119
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Infection; Candida; Candidiasis; Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature

Keywords

NICHD Neonatal Research Network; Fungal Infection; Mycosis; Extremely Low Birth Weight (ELBW); Prematurity; Clinical Judgement; Polymerase chain reaction (PCR) testing; Beta-glucan assay; Mass Spectrometry; Lumbar puncture

Outcome Measures

Primary Outcomes (2)

• Probability of invasive candidiasis based on new assay results

  Until discharge

• Determine test performance of clinical predictive model

  Until discharge

Secondary Outcomes (14)

• Determine test performance (sensitivity and specificity) of polymerase chain reaction (PCR) testing

  Until discharge

• Determine test performance of Beta-glucan assay

  Until discharge

• Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of blood samples

  Until discharge

• Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of urine samples

  Until discharge

• Determine test performance of the blood culture

  Until discharge

Eligibility Criteria

• Age: 3 Days - 120 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants with birth weights ≤1,000 grams

You may qualify if:

• Infants born ≤1,000g birth weight
• Infants \>72 hours old and less than 120 days old

You may not qualify if:

• Prior positive blood culture for Candida
• Evidence of congenital candidiasis
• Parents/legal guardians refuse consent

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Center for Research Resources (NCRR): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California at San Diego

San Diego, California, 92103-8774, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Wake Forest University

Charlotte, North Carolina, 27157, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (5)

• 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.

  PMID: 20876174 RESULT

• 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.

  PMID: 23726546 RESULT

• 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.

  PMID: 22504098 RESULT

• 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.

  PMID: 22424952 RESULT

• 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.

  PMID: 22144537 RESULT

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Infections; Torulopsis; Candidiasis; Premature Birth; Mycoses; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abbot R. Laptook, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Michele C. Walsh, MD MS

  Case Western Reserve University, Rainbow Babies and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Ronald N. Goldberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Brenda B. Poindexter, MD MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Krisa P. Van Meurs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ivan D. Frantz III, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Waldemar A. Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Neil N. Finer, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Kurt Schibler, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Edward F. Bell, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Shahnaz Duara, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Kristi L. Watterberg, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Dale L. Phelps, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Kathleen A. Kennedy, MD MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Pablo J. Sanchez, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• T. Michael O'Shea, MD MPH

  Wake Forest University

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2005
• First Posted: April 29, 2005
• Study Start: March 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: December 1, 2009
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (20)