• Qin Lu, Jean-Jacques Rouby, Pierre-François Laterre, Philippe Eggimann, Anthony Dugard, Evangelos J Giamarellos-Bourboulis, Emanuelle Mercier, Jorge Garbino, Charles-Edouard Luyt, Jean Chastre, Violetta Georgescu-Kyburz, Michael P Rudolf, Verena Gafner, Hedvika Lazar, Holger Koch, Antonio Perez, Stefanie D Krämer, and Michael Tamm.
• Multidisciplinary Intensive Care Unit, Department of Anesthesiology, La Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, UPMC Paris 6, France.
• J. Antimicrob. Chemother. 2011 May 1; 66 (5): 1110-6.

ObjectivesNosocomial Pseudomonas aeruginosa pneumonia remains a major concern in critically ill patients. We explored the potential impact of microorganism-targeted adjunctive immunotherapy in such patients.Patients And MethodsThis multicentre, open pilot Phase 2a clinical trial (NCT00851435) prospectively evaluated the safety, pharmacokinetics and potential efficacy of three doses of 1.2 mg/kg panobacumab, a fully human monoclonal anti-lipopolysaccharide IgM, given every 72 h in 18 patients developing nosocomial P. aeruginosa (serotype O11) pneumonia.ResultsSeventeen out of 18 patients were included in the pharmacokinetic analysis. In 13 patients receiving three doses, the maximal concentration after the third infusion was 33.9 ± 8.0 μg/mL, total area under the serum concentration-time curve was 5397 ± 1993 μg h/mL and elimination half-life was 102.3 ± 47.8 h. Panobacumab was well tolerated, induced no immunogenicity and was detected in respiratory samples. In contrast to Acute Physiology and Chronic Health Evaluation II (APACHE II) prediction, all 13 patients receiving three doses survived, with a mean clinical resolution in 9.0 ± 2.7 days. Two patients suffered a recurrence at days 17 and 20.ConclusionsThese data suggest that panobacumab is safe, with a pharmacokinetic profile similar to that in healthy volunteers. It was associated with high clinical cure and survival rates in patients developing nosocomial P. aeruginosa O11 pneumonia. We concluded that these promising results warrant further trials.

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