Azithromycin vs. Placebo for the Clinical Outcome in Campylobacter concisus Diarrhoea in Adults: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Fig 2
Upon diagnosis of C. concisus in a stool sample the diarrheic patient was contacted by telephone, through their General Practitioner or physician (if hospitalized), by the principal-investigator (day 0).
If the patient still had diarrhoea the patient was offered to participate in the clinical trial. At day 1 the patient met the principal-investigator in an outpatient setting and was randomized to either azithromycin or placebo 500 mg once-daily dose for three days for the treatment of diarrhoea. Moreover, the patient was asked to deliver a blood sample (CRP and leukocytes) as well as a saliva sample. During the follow-up period of ten days the patient had to fill in a questionnaire on daily basis regarding diarrheic symptoms. At day ten the patient was contacted by telephone by the principal-investigator and if the patient stated ongoing diarrheic symptoms (no effect of study treatment; azithromycin or placebo) the patient was offered another ten-day study period and treatment with cross-over study medication (azithromycin or placebo), also double-blinded. Finally, the patient was asked to deliver a saliva sample as well as a stool sample for an ongoing diagnosis of C. concisus infection.