Calfactant for Direct Acute Respiratory Distress Syndrome (CARDS)

Pneuma Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Respiratory Distress Syndrome, Adult

Treatments: Drug: Calfactant; Drug: Room Air (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT00682500

Pneuma AR-06

Details and patient eligibility

About

This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.

Full description

Recruitment limited to direct adult respiratory distress syndrome patients who have been intubated <48 hours. Origin of ARDS must be infectious pneumonia, aspiration of stomach contents, near drowning, smoke inhalation without pulmonary burn, inhaled industrial gas.

Enrollment: 332 patients

Sex: All

Ages: 12 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
2. Less than 48 hours of mechanical ventilation
3. Informed consent

Exclusion criteria

1. Pre-existing lung disease
2. coma
3. limited therapeutic goals (do not resuscitate, etc.)
4. failure of another vital organ

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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332 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Calfactant treatment

Treatment:

Drug: Calfactant

2

Placebo Comparator group

Treatment:

Drug: Room Air (placebo)