Trial Outcomes & Findings for CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients (NCT NCT00999713)
NCT ID: NCT00999713
Last Updated: 2018-03-16
Results Overview
Overall mortality rate from admission to PICU discharge
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
43 participants
Primary outcome timeframe
Admission to PICU discharge, up to 120 days
Results posted on
2018-03-16
Participant Flow
Participant milestones
| Measure |
Calfactant
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
17
|
|
Overall Study
COMPLETED
|
24
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Calfactant
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
Baseline characteristics by cohort
| Measure |
Calfactant
n=26 Participants
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
n=17 Participants
Endotracheal air administration
Air placebo: Endotracheal air administration
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
16 participants
n=107 Participants
|
42 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Admission to PICU discharge, up to 120 daysOverall mortality rate from admission to PICU discharge
Outcome measures
| Measure |
Calfactant
n=26 Participants
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
n=17 Participants
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 60 days after study enrollmentNumber of days the patient is alive and off of the ventilator
Outcome measures
| Measure |
Calfactant
n=26 Participants
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
n=17 Participants
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
Ventilator Free Days (VFDs)
|
0 Days
Interval 0.0 to 21.02
|
5.40 Days
Interval 0.0 to 17.44
|
SECONDARY outcome
Timeframe: Admission to discharge, up to 120 daysLength of stay (LOS) ,measured in days, from admission to PICU discharge and admission to hospital discharge.
Outcome measures
| Measure |
Calfactant
n=26 Participants
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
n=17 Participants
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
Total Duration of Stay Required
LOS from admission to PICU discharge
|
15.5 days
Interval 8.0 to 29.5
|
21 days
Interval 12.5 to 39.5
|
|
Total Duration of Stay Required
LOS from admission to hospital discharge
|
34.5 days
Interval 17.5 to 95.5
|
65 days
Interval 21.0 to 107.5
|
SECONDARY outcome
Timeframe: 48 hours after enrollment, up to 12 hours after each interventionPopulation: Total number of subjects analyzed at each measurement fluctuates due to arterial blood gas testing not being ordered at the appropriate time (i.e., subjects missing a test at a specific time point since the frequency of these tests in this study are not standard of care).
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.
Outcome measures
| Measure |
Calfactant
n=24 Participants
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
n=17 Participants
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
Change in Oxygenation: First Intervention
First Intervention: Hour 0
|
18.30178397 index number
Interval 14.8899734 to 22.49535894
|
20.59720208 index number
Interval 16.21205422 to 26.16847488
|
|
Change in Oxygenation: First Intervention
First Intervention: Hour 1
|
16.10723481 index number
Interval 12.40927173 to 20.9071909
|
19.25708144 index number
Interval 13.98618037 to 26.51440036
|
|
Change in Oxygenation: First Intervention
First Intervention: Hour 4
|
14.79254257 index number
Interval 11.76126752 to 18.60507937
|
16.80523147 index number
Interval 12.85367235 to 21.97160447
|
|
Change in Oxygenation: First Intervention
First Intervention: Hour 12
|
17.06208571 index number
Interval 13.03988505 to 22.32494901
|
16.42411116 index number
Interval 11.98559242 to 22.50630741
|
SECONDARY outcome
Timeframe: 48 hours after enrollment, up to 12 hours after each interventionPopulation: Total number of subjects analyzed at each measurement fluctuates due to arterial blood gas testing not being ordered at the appropriate time (i.e., subjects missing a test at a specific time point since the frequency of these tests in this study are not standard of care).
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.
Outcome measures
| Measure |
Calfactant
n=16 Participants
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
n=14 Participants
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
Change in Oxygenation: Second Intervention
Second Intervention: Hour 0
|
15.65261779 index number
Interval 10.74981818 to 22.79149651
|
15.05105738 index number
Interval 10.19615508 to 22.21762286
|
|
Change in Oxygenation: Second Intervention
Second Intervention: Hour 1
|
21.28116857 index number
Interval 15.40809906 to 29.39286242
|
14.68059885 index number
Interval 10.36992308 to 20.78318046
|
|
Change in Oxygenation: Second Intervention
Second Intervention: Hour 4
|
17.47108142 index number
Interval 13.41337922 to 22.75628541
|
15.40251337 index number
Interval 11.60739802 to 20.43846672
|
|
Change in Oxygenation: Second Intervention
Second Intervention: Hour 12
|
17.26865232 index number
Interval 12.65514101 to 23.56404822
|
14.83842164 index number
Interval 10.66746181 to 20.64021983
|
Adverse Events
Calfactant
Serious events: 15 serious events
Other events: 8 other events
Deaths: 15 deaths
Placebo (Air)
Serious events: 7 serious events
Other events: 1 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Calfactant
n=26 participants at risk
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
n=17 participants at risk
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
Blood and lymphatic system disorders
Death
|
57.7%
15/26 • Number of events 15
|
41.2%
7/17 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.4%
4/26 • Number of events 4
|
0.00%
0/17
|
|
Renal and urinary disorders
Renal Failure
|
7.7%
2/26 • Number of events 2
|
0.00%
0/17
|
Other adverse events
| Measure |
Calfactant
n=26 participants at risk
Endotracheal calfactant administration
Calfactant: Endotracheal calfactant, up to 3 doses if subject qualifies
|
Placebo (Air)
n=17 participants at risk
Endotracheal air administration
Air placebo: Endotracheal air administration
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Peri-dosing hypotension
|
11.5%
3/26 • Number of events 3
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Peri-dosing Hypoxia or Hypotension
|
15.4%
4/26 • Number of events 4
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediatinum
|
3.8%
1/26 • Number of events 1
|
0.00%
0/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place