Page 119 - 15Diarrhoeaandvomiting

Diarrhoea and vomiting caused by gastroenteritis in children under 5 years

samples. Clinical symptoms were assessed and reported daily by a parent and stool specimens
were obtained for the first 7 days, then weekly thereafter. There was about 25% loss to follow-up
and results for only 34 children were presented. The mean age of children in the antibiotic group
(n = 18) was 2.5 ± 3 years and was 3.6 ± 4.3 years in the treatment group (n = 16). There were
no statistically significant differences between the antibiotic and placebo groups for the clinical
outcomes (median duration of diarrhoea, the number of patients experiencing diarrhoea for less
than 7 days, or recurrence of diarrhoea). However, statistically significant differences between
the treatment groups were found for bacteriological parameters. The findings for the median
number of days until ‘bacteriological cure’ (erythromycin median 5.5 days, range 2–53 days
versus placebo, median 17.5 days, range 3–62 days; P < 0.005) and for the number of patients
with positive stool cultures at the end of treatment (erythromycin 2/18 versus placebo 13/16;
P < 0.001) both favoured antibiotic use. However, more participants taking antibiotics (7/18) had
a bacteriological relapse compared with those taking placebo (0/16) (P < 0.05). [EL = 1−].

Evidence summary
Evidence from one RCT suggested that erythromycin treatment compared with placebo for
yersinia gastroenteritis did not make a significant difference to clinical diarrhoeal outcomes.
Although erythromycin did reduce the time taken for patients to stop excreting yersinia, its
administration caused more patients to have bacteriological relapses compared with placebo.

7.4 Shigella

Evidence overview
One RCT was identified. This study 144 compared the effects of ampicillin with that of placebo
in infants and children younger than 2 years admitted to hospital in Colombia with diarrhoea
as a major symptom (n = 282). Children were recruited once culture confirmation of shigella,
salmonella or E. coli was made from rectal swab and stool specimens taken 12–16 hours
previously. One patient without recognised pathogens was entered into the study for every two
patients with shigella, salmonella or E. coli. Treatments were given intramuscularly (IM ampicillin
versus IM sterile fructose) in the first year of the trial, and orally in the second (oral suspension of
100 mg/kg per day ampicillin or placebo suspension in equally divided doses every 6 hours for
5 days). Overall, 37 participants had shigella infection – 16 received ampicillin and 21 received
placebo. No statistically significant differences were found between the treatment groups for
the diarrhoeal outcomes (mean number of days until diarrhoea improved, 2.4 versus 4.6 days,
and mean number of days until diarrhoea ceased, 4.4 versus 6.8 days). IM ampicillin and the
combined results for IM and oral ampicillin significantly reduced the mean number of days
until the patient became afebrile, compared with the placebo (less than 0.5 versus 2.6 days;
P < 0.05, and less than 0.5 versus 1.6 days; P < 0.05, respectively). Similarly, IM ampicillin and
the combined results for IM and oral ampicillin significantly reduced the mean number of days
until the patient became stool culture negative (0.4 versus 1.8 days; P < 0.01, and 0.9 versus
2 days; P < 0.05, respectively). IM ampicillin was found to be more effective in this respect than
oral administration (0.4 versus 1.5 days; P < 0.05). [EL = 1+]

Evidence summary

Although the trial was well conducted, the sample size of children evaluated for this relevant
section was small. The results suggested that children treated with ampicillin for shigella took
fewer days to become afebrile and to stop excreting the organism than those treated with placebo.
IM ampicillin was more effective than oral ampicillin in reducing the time to becoming stool
culture negative, but the use of ampicillin did not reduce the time to improvement or cessation
of diarrhoea.

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