Oral ofloxacin for the treatment of acute bacterial pneumonia: use of a nontraditional protocol to compare experimental therapy with ''usual care'' in a multicenter clinical trial

Article Abstract:

Initial treatment of patients hospitalized for pneumonia almost universally consists of parenteral (given other than by mouth, such as intravenously) administration of antibiotics. This can be continued or oral agents then used, depending on the bacterial type, severity, and sensitivity to antibiotics. Risks and costs associated with antibiotic therapy could be reduced if an effective oral treatment could be identified. Ofloxacin was a candidate for this protocol, and its effectiveness in treating pneumonia was compared with that of normal standards of care, in which a variety of antibiotics were used according to the usual practices of physicians participating in the study. Ofloxacin was used to treat 75 patients, while 72 patients received standard parenteral antibiotics (the control subjects). Patients in critical condition were excluded from participation in the trial. Differences in the rate of cure, improvement and failure between the groups were not statistically different; cure occurred in 56 ofloxacin and 44 control patients, while 13 and 17, respectively, improved. Duration of antibiotic treatment was similar. Eight ofloxacin patients and six control patients developed side effects. Four patients receiving ofloxacin and two control patients died. The results challenge the currently accepted conviction that pneumonia in hospitalized patients can only be treated initially with intravenous antibiotics. Success is partly attributed to close monitoring and attention to detail. Further study is needed to determine the applicability of oral ofloxacin therapy to other groups of patients hospitalized with pneumonia. (Consumer Summary produced by Reliance Medical Information, Inc.)

Health aspects, Antibiotics, Drug therapy, Pneumonia, Dosage and administration, Bacterial pneumonia

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Toxicologic evaluation of ofloxacin

Article Abstract:

Quinolone antibiotics have been shown to cause adverse effects including anemia, impaired blood clotting, loss of fertility, decreased weight of accessory glands, formation of cataracts, liver and kidney damage, genetic effects, disorders in cartilage formation, and joint disease. The toxic effects of a new quinolone antibiotic, ofloxacin, were evaluated in dogs, rats, rabbits, and guinea pigs. In dogs and rats, ofloxacin caused effects on the joints that included blister, erosion, and increased synovial (joint) fluid. These effects were related to the age of the dogs and rats and to the dose of the antibiotic. In rats and rabbits, ofloxacin caused toxic effects on pregnant animals and their embryos, but it did not affect fertility, fetal development, labor, delivery, survival of the newborn, or growth of the offspring. Ofloxacin had no effect on the eyes of rats, the kidneys of rabbits, the ears and immunity or natural defense system of guinea pigs. These results show that with the exception of joint effects, ofloxacin does not have most of the adverse effects of other quinolone antibiotics and is relatively safe in various animal models when given by different routes over a short, intermediate or long period. (Consumer Summary produced by Reliance Medical Information, Inc.)

Joints, Joints (Anatomy), Complications and side effects, Quinolones

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