Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old

Acute Hypoxemic Respiratory Failure Clinical Trial

— KL4-AHRF-01  

Official title:

A Multicenter, Randomized, Masked, Placebo-Controlled Trial to Assess the Safety and Efficacy of Lucinactant in Acute Hypoxemic Respiratory Failure in Children Up to Two Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578734
• Other study ID #: KL4-AHRF-01
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2007
• Last updated: May 1, 2012
• Start date: June 2007
• Est. completion date: April 2010

Study information

• Verified date: May 2012
• Source: Discovery Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial Summary

Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).

Description:

Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• = 38 weeks (corrected age) to 2 years (24 months)

• Intubated and mechanically ventilated (MV) for = 6 hours and anticipated need for MV for = 24 hours

• Persistent hypoxia

• Written informed consent

Exclusion Criteria:

• Mechanical Ventilation for > 48 hours

• Oxygenation index = 25, if arterial line was avialable

• Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange

• Neuromuscular disease or hypotonia

• Upper airway disease

• Baseline requirment for supplemental oxygen

• Untreated pneumothorax

• Off-label use of commercially available surfactant outside neonatal period

• History of prematurity and passive immunoprophylaxis with humanized monoclonal antibody

• Head injury with Glasgow Coma Scale < 8

• Brain death or impending brain death

• Do not resuscitate orders

• Cardiopulmonary resuscitation within 6 hours of meeting entry criteria

• Experimental therapy in which the intervention potentially affects respiratory outcomes

• Any transplant recipient

• Meconium aspiration syndrome

• Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Lucinactant
Slow intra-tracheal instillation

Other:
• Sham Comparator
Slow intra-tracheal instillation

Locations

Country	Name	City	State
Chile	Call for Information	Concepcion
Chile	Call For Information	Santiago
United States	Call for information	Warrington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Discovery Laboratories, Inc.

Countries where clinical trial is conducted

United States,  Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Mechanical Ventilation Through 14 Days	Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.	Up to 14 Days	No
Secondary	Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days		Up to 14 days	No