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Fig. 1 | Critical Care

Fig. 1

From: A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients

Fig. 1

Study design. *Day 0 assessments were in the intensive care unit (ICU). Subsequent visits were performed in the ICU, hospital, or outpatient setting. Key study visits were at days 0, 7, 14, and 90, and ICU discharge. Optional study visits were performed on days 28, 42, 56, and 70, and only if the patient was still in the ICU or hospital. The total number of visits was dependent on the length of hospital stay (maximum 9 visits). The day-90 visit was considered essential; if patients were not able to attend in person, a telephone call for safety assessment was conducted. The primary endpoint (immunogenicity assessment) was outer membrane protein (OprF/I)-specific immunoglobulin G (IgG) antibody titer at day 14. †Surveillance cultures for Pseudomonas aeruginosa (P. aeruginosa) diagnosis were taken from blood, wounds (if applicable), respiratory tract, urine, and central venous catheter at visits conducted in the ICU. In between these visits, and at other visits up to day 90, cultures for P. aeruginosa diagnosis were taken at the investigator’s discretion, if medically indicated

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