Trial Outcomes & Findings for Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old (NCT NCT00578734)
NCT ID: NCT00578734
Last Updated: 2012-05-03
Results Overview
Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
Up to 14 Days
Results posted on
2012-05-03
Participant Flow
Subjects were enrolled at 24 hospitals in the United States and Chile from 04 June, 2007 to 23 March, 2010. Last subject's last visit occurred on 05 April, 2010.
Participant milestones
| Measure |
Lucinactant
KL₄Surfactant (lucinactant) endotracheal instillation
|
Sham Air
Sham air (placebo) instillation
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
81
|
|
Overall Study
COMPLETED
|
84
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Baseline characteristics by cohort
| Measure |
Lucinactant
n=84 Participants
KL₄Surfactant (lucinactant) endotracheal instillation
|
Sham Air
n=81 Participants
Sham air (placebo) instillation
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
84 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
0.44 years
STANDARD_DEVIATION 0.43 • n=5 Participants
|
0.45 years
STANDARD_DEVIATION 0.43 • n=7 Participants
|
0.45 years
STANDARD_DEVIATION 0.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
56 participants
n=5 Participants
|
54 participants
n=7 Participants
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 DaysPopulation: The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.
Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.
Outcome measures
| Measure |
Lucinactant
n=84 Participants
KL₄Surfactant (lucinactant) endotracheal instillation
|
Sham Air
n=81 Participants
Sham air (placebo) instillation
|
|---|---|---|
|
Duration of Mechanical Ventilation Through 14 Days
|
4.0 days
Interval 3.5 to 4.6
|
4.5 days
Interval 3.9 to 5.2
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.
Outcome measures
| Measure |
Lucinactant
n=84 Participants
KL₄Surfactant (lucinactant) endotracheal instillation
|
Sham Air
n=81 Participants
Sham air (placebo) instillation
|
|---|---|---|
|
Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days
Ventilator-free days
|
5.2 days
Interval 4.6 to 5.9
|
4.6 days
Interval 4.1 to 5.3
|
|
Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days
Duration in Pediatric Intensive Care Unit (PICU)
|
6.2 days
Interval 5.4 to 7.0
|
6.7 days
Interval 5.9 to 7.6
|
|
Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days
Duration of Supplemental Oxygen
|
7.7 days
Interval 6.8 to 8.7
|
7.9 days
Interval 7.0 to 9.0
|
|
Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days
Duration of Hospitalization
|
10.0 days
Interval 9.1 to 11.1
|
9.7 days
Interval 8.8 to 10.7
|
Adverse Events
Lucinactant
Serious events: 20 serious events
Other events: 65 other events
Deaths: 0 deaths
Sham Air
Serious events: 14 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lucinactant
n=84 participants at risk
KL₄Surfactant (lucinactant) endotracheal instillation
|
Sham Air
n=81 participants at risk
Sham air (placebo) instillation
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
2.5%
2/81 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
|
Cardiac disorders
Bradycardia
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
2.5%
2/81 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
2.5%
2/81 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
2.5%
2/81 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Congenital, familial and genetic disorders
Coarctation of the aorta
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
0.00%
0/81 • 14 days from randomization or until resolution of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
0.00%
0/81 • 14 days from randomization or until resolution of adverse events.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
0.00%
0/81 • 14 days from randomization or until resolution of adverse events.
|
|
Infections and infestations
Abscess
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Infections and infestations
Bronchopneumonia
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
0.00%
0/81 • 14 days from randomization or until resolution of adverse events.
|
|
Infections and infestations
Pneumonia
|
6.0%
5/84 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
0.00%
0/81 • 14 days from randomization or until resolution of adverse events.
|
|
Infections and infestations
Sepsis
|
2.4%
2/84 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Investigations
Oxygen saturation decreased
|
2.4%
2/84 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
2.5%
2/81 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
0.00%
0/81 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pertussis
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
0.00%
0/81 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
0.00%
0/81 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.0%
5/84 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
3.7%
3/81 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/84 • 14 days from randomization or until resolution of adverse events.
|
1.2%
1/81 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
Other adverse events
| Measure |
Lucinactant
n=84 participants at risk
KL₄Surfactant (lucinactant) endotracheal instillation
|
Sham Air
n=81 participants at risk
Sham air (placebo) instillation
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.1%
11/84 • Number of events 13 • 14 days from randomization or until resolution of adverse events.
|
23.5%
19/81 • Number of events 21 • 14 days from randomization or until resolution of adverse events.
|
|
Cardiac disorders
Bradycardia
|
4.8%
4/84 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
11.1%
9/81 • Number of events 10 • 14 days from randomization or until resolution of adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.0%
5/84 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
3.7%
3/81 • Number of events 3 • 14 days from randomization or until resolution of adverse events.
|
|
General disorders
Drug withdrawal syndrome
|
4.8%
4/84 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
4.9%
4/81 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
|
General disorders
Oedema
|
2.4%
2/84 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
6.2%
5/81 • Number of events 6 • 14 days from randomization or until resolution of adverse events.
|
|
General disorders
Pyrexia
|
2.4%
2/84 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
4.9%
4/81 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
|
Infections and infestations
Pneumonia
|
8.3%
7/84 • Number of events 7 • 14 days from randomization or until resolution of adverse events.
|
2.5%
2/81 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
|
Investigations
Oxygen saturation decreased
|
10.7%
9/84 • Number of events 10 • 14 days from randomization or until resolution of adverse events.
|
7.4%
6/81 • Number of events 10 • 14 days from randomization or until resolution of adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
12/84 • Number of events 12 • 14 days from randomization or until resolution of adverse events.
|
7.4%
6/81 • Number of events 6 • 14 days from randomization or until resolution of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
6/84 • Number of events 6 • 14 days from randomization or until resolution of adverse events.
|
7.4%
6/81 • Number of events 6 • 14 days from randomization or until resolution of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
27.4%
23/84 • Number of events 23 • 14 days from randomization or until resolution of adverse events.
|
21.0%
17/81 • Number of events 18 • 14 days from randomization or until resolution of adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.4%
2/84 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
4.9%
4/81 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
4.9%
4/81 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
6.0%
5/84 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
11.1%
9/81 • Number of events 9 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
13.1%
11/84 • Number of events 14 • 14 days from randomization or until resolution of adverse events.
|
16.0%
13/81 • Number of events 13 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
8.3%
7/84 • Number of events 9 • 14 days from randomization or until resolution of adverse events.
|
6.2%
5/81 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
1.2%
1/84 • Number of events 1 • 14 days from randomization or until resolution of adverse events.
|
7.4%
6/81 • Number of events 6 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.0%
5/84 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
3.7%
3/81 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
3.6%
3/84 • Number of events 3 • 14 days from randomization or until resolution of adverse events.
|
7.4%
6/81 • Number of events 7 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
7.1%
6/84 • Number of events 6 • 14 days from randomization or until resolution of adverse events.
|
2.5%
2/81 • Number of events 2 • 14 days from randomization or until resolution of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
4.8%
4/84 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
8.6%
7/81 • Number of events 10 • 14 days from randomization or until resolution of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
3.6%
3/84 • Number of events 3 • 14 days from randomization or until resolution of adverse events.
|
4.9%
4/81 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
|
Vascular disorders
Capillary leak syndrome
|
4.8%
4/84 • Number of events 4 • 14 days from randomization or until resolution of adverse events.
|
3.7%
3/81 • Number of events 3 • 14 days from randomization or until resolution of adverse events.
|
|
Vascular disorders
Hypertension
|
6.0%
5/84 • Number of events 5 • 14 days from randomization or until resolution of adverse events.
|
3.7%
3/81 • Number of events 3 • 14 days from randomization or until resolution of adverse events.
|
|
Vascular disorders
Hypotension
|
9.5%
8/84 • Number of events 8 • 14 days from randomization or until resolution of adverse events.
|
14.8%
12/81 • Number of events 14 • 14 days from randomization or until resolution of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee First publication must be joint, multicenter publication in conjunction with a presentation. Following multicenter publication, proposed publications or presentations must be submitted to sponsor 30 days in advance. In the event of an objection by sponsor, PI agrees to delay the publication or presentation until modifications or revisions have been made to protect Sponsor's patent rights, copyrights, or proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER