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Comparison of the efficacy of azithromycin and cefixime for the treatment of shigellosis in children

A randomized clinical trial at the Institute of Tropical Medicine (Asuncion, Paraguay) included 75 children aged 6 months to 5 years with typical dysentery diarrhea, who were treated at the Institute from May 1998 to January 2000 g.

All patients were examined at the admissions department by an infectious disease specialist. The criteria for dysenteric diarrhea were: the frequency of blood stools twice or more in the 24 hours before admission, the presence of 20 or more leukocytes during microscopic examination of stools, body temperature above 38 ° C, abdominal pain and tenesmus. The final diagnosis was made upon receipt of a positive bacteriological analysis and the isolation of Shigella spp. The study exclusion criteria were: taking antibiotics within 72 hours before inclusion, severe vomiting that interferes with oral medication, shock, malnutrition, primary or secondary immunodeficiency, reaction allergic to cephalosporins and macrolides in history.

All patients were randomized into two groups. The first group received cefixime 8 mg / kg / day (maximum dose 400 mg / day) for 5 days, the second - azithromycin 12 mg / kg the first day (maximum dose 500 mg / day), then 6 mg / kg (maximum dose 250 mg / day) for the next four days. The efficacy of the treatment was evaluated under the following conditions: (1) detection of Shigella spp. with bacteriological examination of the stool before the patient is included in the study; (2) a full five-day treatment with the antibiotics studied; (3) the absence of other antibiotic therapy during the study period. The clinical and bacteriological efficacy of antibiotic therapy was evaluated. Clinical efficacy was assessed 72 hours after the start of treatment. The absence of positive clinical dynamics (presence of diarrhea with blood mixture, fever and / or abdominal pain 72 hours after the start of treatment) was considered as an ineffective treatment.

Bacteriological research was carried out on the 3rd and 7th days. The presence of a positive bacteriological test result on the 3rd day of treatment was considered to be bacteriological ineffectiveness.

The therapy was effective in 28 patients (93%) in the first group and in 25 (78%) patients in the second group (p = 0.1). Clinical ineffectiveness was observed in 9 patients (2 patients in the azithromycin group, 7 in the cefixime group). The duration of diarrhea since the start of treatment was 2.5 ± 2.3 days in the first group and 3.9 ± 1.9 days in the second group (p less than 0.1). Adverse effects (vomiting and maculopapular rashes) were observed in 5 patients (2 in the azithromycin group, 3 in the cefixime group). A severe NLR has not been recorded. The most frequently isolated pathogen was Shigella flexneri (73% and 87%, respectively, in the azithromycin and cefixime groups).

The eradication of pathogens on the 3rd day of treatment was carried out in 19 (59%) patients in the cefixime group and in 28 (93%) patients in the azithromycin group (p less than 0.01). On day 7, a positive bacteriological test was obtained in one child in the azithromycin group and in two children in the cefixime group.

The high level of eradication of pathogens during treatment with azithromycin gives rise to new epidemiological studies aimed at confirming the efficacy of this antibiotic for the treatment of shigellosis in children.