Bibliographic informationStudy type and evidence levelStudy detailsPatient characteristicsIntervention and comparisonOutcome measures, follow-up and effect sizeComments
Pai 1984148

Location : Canada
Study Type

Evidence Level 1−
Total number of participants
n = 45
results for 34 participants with complete data presented

Two treatment arms

Group 1
Intervention :
n = 18

Group 2
Intervention :
n = 16
Inclusion criteria:

Children under 15 years with symptomatic enteritis and their household contacts.

Prior to recruitment, stool samples from children had positive culture of yersinia (confirmation within 2 days of receipt of specimen)

Exclusion criteria :
Presence of other enteric pathogens in the stool, antibiotic therapy in previous 2 weeks and patients with a positive culture who were no longer symptomatic

Withdrawal criteria :
Not stated

Intervention details:

Group 1:
10 mg/kg per day trimethoprim + 50 mg/kg per day sulfamethoxazole oral suspension twice per day for 7 days

Group 2:
Placebo oral suspension
Follow up

All participants contacted until all of the household had three consecutive negative (weekly) stool samples

Clinical symptoms assessed and reported daily by parent on telephone

Stool specimens obtained for first 7 days, then weekly.

Outcome measures:

Median duration of diarrhoea
Group 1 = 3.0
Range 1–67 days
Group 2 = 3.5
Range 1–27
P = NS

(f) Diarrhoea for <7 days
Group 1 = 1
Group 2 = 1
P = NS

Recurrence of diarrhoea

Group 1 = 4
Group 2 = 2
P = NS

Median no days until bacteriological cure
Group 1 = 5.5
Range 2–53
Group 2 = 17.5
Range 3–62
P < 0.005

Positive stool culture at end of treatment
Group 1 = 2
Group 2 = 13
P < 0.001

(g) Bacteriologic relapse
Group 1 = 7
Group 2 = 0
P < 0.05
Funding :
In part from National Health Research and Development (Project 605–1396– 40)

Drug and placebo supplied by Burroughs Wellcome

Applicable to UK

Baseline comparability
Similar for age, sex, symptoms (diarrhoea, fever, vomiting, abdominal pain), days ill prior to study entry.

Allocation concealment :
Implied pharmacy controlled

Sequence generation :
Implied pharmacy controlled

Blinding of outcome assessors :

Loss to follow up
Incomplete follow-up (5)
Negative stool culture at admission to study (3)
Appendectomy (2)
Mixed infection (1)

Intention to treat analysis :

Power calculation :

From: Evidence tables

Cover of Diarrhoea and Vomiting Caused by Gastroenteritis
Diarrhoea and Vomiting Caused by Gastroenteritis: Diagnosis, Assessment and Management in Children Younger than 5 Years.
NICE Clinical Guidelines, No. 84.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2009 Apr.
Copyright © 2009, National Collaborating Centre for Women’s and Children’s Health.

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