Abstract
BackgroundWe have evaluated the therapeutic efficacy of AIGIV when given in combination with levofloxacin and the effective window of treatment to assess the added benefit provided by AIGIV over standard antibiotic treatment alone in a New Zealand white rabbit model of inhalational anthrax.MethodsRabbits were exposed to lethal dose of aerosolized spores of Bacillus anthracis (Ames strain) and treated intravenously with either placebo, (normal immune globulin intravenous, IGIV) or 15 U/kg of AIGIV, along with oral levofloxacin treatment at various time points (30–96 hours) after anthrax exposure.ResultsThe majority of treated animals (>88%) survived in both treatment groups when treatment was initiated within 60 hours of post-exposure. However, reduced survival of 55%, 33% and 25% was observed for placebo + levofloxacin group when the treatment was initiated at 72, 84 and 96 hours post-exposure, respectively. Conversely, a survival rate of 65%, 40% and 71% was observed in the AIGIV + levofloxacin treated groups at these time points.ConclusionsThe combination of AIGIV with antibiotics provided an improvement in survival compared to levofloxacin treatment alone when treatment was delayed up to 96 hours post-anthrax exposure. Additionally, AIGIV treatment when given as an adjunct therapy at any of the time points tested did not interfere with the efficacy of levofloxacin.
Highlights
Bacillus anthracis, the etiologic agent of anthrax, is a Grampositive, spore-forming bacterium that can cause human disease when exposed via the gastrointestinal, cutaneous, or inhalation routes with pulmonary exposure being the most lethal at close to 100% mortality in the absence of treatment [1]
The mortality caused by B. anthracis is predominantly due to three well characterized virulence factors; lethal factor (LF), edema factor (EF) and protective antigen (PA)
We report data from two independent placebo controlled studies in rabbits that evaluated the therapeutic efficacy of Anthrax Immune Globulin Intravenous (AIGIV) compared to placebo (IGIV) when both were given in combination with levofloxacin at various time points after exposure to inhalation anthrax
Summary
The etiologic agent of anthrax, is a Grampositive, spore-forming bacterium that can cause human disease when exposed via the gastrointestinal, cutaneous, or inhalation (pulmonary) routes with pulmonary exposure being the most lethal at close to 100% mortality in the absence of treatment [1]. Vaccination is an effective pre-exposure prophylactic measure against anthrax disease. Due to the rapid nature of the disease progression vaccination is unlikely to provide protection if given after an individual has been exposed to aerosolized spores or after the onset of clinical disease. We have evaluated the therapeutic efficacy of AIGIV when given in combination with levofloxacin and the effective window of treatment to assess the added benefit provided by AIGIV over standard antibiotic treatment alone in a New Zealand white rabbit model of inhalational anthrax
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