Objective: To verify whether cefixime is suitable for the treatment of
Helicobacter pylori infection in monotherapy. Design: Prospective, tw
o-centre study with open randomization in two antisecretory treatment
schedules. Patients: Duodenal ulcer patients with an endoscopically do
cumented active lesion. Intervention: All patients received antisecret
ory treatment (either ranitidine 300 mg twice daily or ranitidine 300
mg three times daily) for 31 days (3 weeks+/-10 days) plus cefixime 40
0 mg four times daily during the fast 10 days. Histology, rapid urease
test and culture were used to diagnose H. pylori infection. An upper
gastrointestinal endoscopy was performed at the beginning of the study
, 31-35 days after starting treatment and 1 month after stopping treat
ment. Results: Of the 26 patients who joined the study, five were test
to follow-up, the ulcer lesion was found unhealed in six out of 21 pa
tients at the end of the therapy and three out of 21 patients were fou
nd to be free of H. pylori. One month later, two out of these th ree p
atients remained free of infection. Ten adverse events were registered
, mainly diarrhoea (seven cases). Conclusions: Cefixime is not suitabl
e as monotherapy for H. pylori eradication.