Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients (CALIPSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00999713
Recruitment Status : Completed
First Posted : October 22, 2009
Results First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Neal Thomas, Penn State University

Tracking Information
First Submitted Date  ICMJE October 18, 2009
First Posted Date  ICMJE October 22, 2009
Results First Submitted Date  ICMJE January 19, 2018
Results First Posted Date  ICMJE March 16, 2018
Last Update Posted Date March 16, 2018
Study Start Date  ICMJE June 2010
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge [ Time Frame: Admission to PICU discharge, up to 120 days ]
Overall mortality rate from admission to PICU discharge
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
All-cause mortality at the time of PICU discharge [ Time Frame: PICU discharge ]
Change History Complete list of historical versions of study NCT00999713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • Ventilator Free Days (VFDs) [ Time Frame: 60 days after study enrollment ]
    Number of days the patient is alive and off of the ventilator
  • Total Duration of Stay Required [ Time Frame: Admission to discharge, up to 120 days ]
    Length of stay (LOS) ,measured in days, from admission to PICU discharge and admission to hospital discharge.
  • Change in Oxygenation: First Intervention [ Time Frame: 48 hours after enrollment, up to 12 hours after each intervention ]
    The Oxygenation Index after the first intervention is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.
  • Change in Oxygenation: Second Intervention [ Time Frame: 48 hours after enrollment, up to 12 hours after each intervention ]
    The Oxygenation Index after the second intervention (if applicable) is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
  • Total duration of mechanical ventilation required during PICU admission. [ Time Frame: PICU discharge ]
  • Total duration of PICU and hospital stay required. [ Time Frame: Hospital discharge ]
  • Improvement in oxygenation, as measured by oxygenation index, in the initial 48 hours after treatment [ Time Frame: 48 hours after enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
Official Title  ICMJE A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients
Brief Summary

Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these children represent a relatively small and unique patient population, they account for the largest proportion of deaths of all pediatric diseases. The long-term goal of this project is to improve outcomes among these patients. Recently, the intratracheal administration of calfactant has resulted in decreased mortality among children with ALI including promising results among children with cancer and following HSCT. Consequently, the primary specific aim of this study is to assess the effect of calfactant on intensive care (PICU) survival among pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung injury in the overall pediatric population by improving oxygenation and decreasing mortality. These findings, in conjunction with recent subgroup analysis in which calfactant therapy appeared to improve outcomes in immunocompromised children provide the rationale for assessing calfactant therapy in this patient population.

Funding Source - FDA Office of Orphan Products Development (OOPD)

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Lung Injury
Intervention  ICMJE
  • Drug: Calfactant
    Endotracheal calfactant, up to 3 doses if subject qualifies
  • Other: Air placebo
    Endotracheal air administration
Study Arms  ICMJE
  • Experimental: Calfactant
    Endotracheal calfactant administration
    Intervention: Drug: Calfactant
  • Placebo Comparator: Placebo (air)
    Endotracheal air administration
    Intervention: Other: Air placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2015)
43
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2009)
140
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must meet criteria for acute lung injury

    • Intubated, mechanically ventilated, with respiratory failure secondary to diffuse, bilateral parenchymal lung disease (as judged by chest x-ray).
    • Oxygenation index (OI) > 13, but < 37, for two consecutive blood gases which should be separated by at least one hour within 48 hours of the initiation of mechanical ventilation.
    • Arterial catheter placement
    • Parental informed consent
  2. Patients must have a diagnosis of leukemia/lymphoma undergoing active treatment or following HSCT for any indication. Leukemia/lymphoma will be defined according to the National Cancer Institute Surveillance Epidemiology and End Results Collaborative Staging Manual including those conditions defined as borderline such as myelodysplastic syndromes. All forms of HSCT will be eligible, allogeneic as well as autologous.

Exclusion Criteria:

  1. Clinical diagnosis of congestive heart failure and/or pulmonary capillary wedge pressure >15 mmHg, or uncorrected congenital heart disease.
  2. Glasgow Coma Score < 8 (prior to respiratory failure).
  3. Pre-existing limitations on care options, (Do Not Attempt Resuscitation Orders, etc).
  4. Patients with impending death from another disease.
  5. Patients moribund or with other organ failure at possible randomization:

    • hypotension unresponsive to treatment (mean BP < 60 or < 5th % for age),
    • persistent cardiac tachyarrhythmia >150/minute, or persistent bradyarrythmia < 50/minute, or age appropriate criteria for younger children,
    • metabolic acidosis > - 10 milliequivalent (mEq)/L for more than 2 hours,
    • persistent arterial oxygen desaturation, arterial partial pressure of oxygen (PaO2) < 50 or oxygen saturation (SaO2) saturation < 80%,
    • hyperkalemia, serum K+ > 6.5 plus widening of QRS complex on EKG (QRS complex corresponds to the depolarization of the right and left ventricles of the heart).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00999713
Other Study ID Numbers  ICMJE 1R01FD003410-01( U.S. FDA Grant/Contract )
R01FD003410-01A1 ( U.S. FDA Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neal Thomas, Penn State University
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neal J Thomas, MD, MSc Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Principal Investigator: Robert F Tamburro, MD, MSc Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP