The novel, once-daily fluoroquinolone prulifloxacin dramatically reduces the duration of traveller’s diarrhoea, researchers reported here at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Brain Walsh, DVM, Optimer Pharmaceuticals, San Diego, California, presented the findings of the second phase 3 trial of the drug on September 14.
A 3-day course of prulifloxacin 600 mg, daily reduced the duration of diarrhoea compared with placebo (P < .0001). Similar findings were seen in the initial pivotal trial of the drug, presented at ICAAC last year.
“Prulifloxacin offers advantages for travellers who want a simple treatment option — a once-a-day pill,” Dr. Walsh said. “Patients typically feel better within 1 day and cured by the second,” he continued.
The study involved 268 adults from industrialised nations who visited Mexico, India, or Guatemala and developed traveller’s diarrhoea, defined as at least 3 unformed stools plus 1 or more additional symptoms. Most were infected with enterotoxigenic Escherichia coli.
Within 72 hours of symptom onset, participants were randomised to prulifloxacin 600 mg once daily or placebo for 3 days.
In the intent-to-treat analysis, the median time to last unformed stool was 33 hours in patients treated with prulifloxacin. In contrast, the median time to last unformed stool could not be estimated for the placebo group because more than half were clinical failures or were not well by the final visit — 24-72 hours after the end of treatment.
Among patients with identifiable pathogens, traveller’s diarrhoea–associated enteropathogens were eradicated in 67.0% of 97 patients treated with prulifloxacin, compared with only 27.2% of 103 control subjects.
Prulifloxacin was generally well tolerated, with a side-effect profile comparable to placebo.
Optimer Pharmaceuticals plans to apply for US Food and Drug Administration approval in 2010, according to Dr. Walsh.