HA-1A in septic patients with ARDS: results from the pivotal trial.
OBJECTIVE
To evaluate the effects of HA-1A, a human monoclonal antiendotoxin antibody, in septic patients with ARDS.


METHODS
Substudy of a multicenter, double-blinded, placebo-controlled trial of HA-1A in septic patients.


METHODS
63 septic patients with ARDS at the time of study entry.


METHODS
A single intravenous injection of HA-1A (100 mg) or placebo.


RESULTS
A quantitative radiographic score, the PaO2/FIO2 ratio and an index of the severity of ARDS did not show a significant difference between the treatment and placebo groups at 3, 5 and 7 days after treatment. The duration of endotracheal intubation did not differ between the two groups. 15 of 30 HA-1A treated patients (50%) and 23 of 33 placebo-treated patients (69.7%) died within 28 days. The daily mortality was always lower in the HA-1A group, but this difference was not statistically significant at 28 days. The 28-day survival curves for the two treatment groups adjusted by covariate analysis were not significantly different (p = 0.07). Using logistic regression, a significant independent effect of HA-1A treatment was detected upon the early survival rate at 7 days (p = 0.03) but not at 14 and 28 days.


CONCLUSIONS
A single injection of HA-1A in septic patients with ARDS did not reverse acute respiratory failure or improve long-term survival.
Bigatello
L M
LM
Department of Anaesthesia, Harvard Medical School, Massachusetts General Hospital, Boston 02114.
Greene
R E
RE
Sprung
C L
CL
Panacek
E A
EA
Straube
R C
RC
Zimmerman
J L
JL
Maunder
R J
RJ
Lanken
P N
PN
Pile-Spellmann
E
E
Stanek
K S
KS
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D004731:Endotoxins / Q000276:immunology*; D005260:Female; D006801:Humans; D007075:Immunoglobulin M / Q000627:therapeutic use*; D015994:Incidence; D008168:Lung / Q000000981:diagnostic imaging; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D012128:Respiratory Distress Syndrome / Q000150:complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D012307:Risk Factors; D018805:Sepsis / Q000150:complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D013997:Time Factors
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D004731:Endotoxins; D007075:Immunoglobulin M; C068069:nebacumab