Antibiotics in acute diverticulitis

Randomised double-blind placebo-controlled trial to evaluate the effect of antibiotics on length of hospital stay in uncomplicated acute diverticulitis in a tertiary hospital setting.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000249550

Enrollment

180

Registered

2015-03-18

Start date

2015-12-24

Completion date

2019-04-25

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim To determine whether the administration of an intravenous and oral antibiotic regimen is more effective than a placebo for reducing length of hospital stay, pain and symptoms of uncomplicated AD. Hypothesis That patients given the placebo will have a similar resolution of symptoms (as measured by patient reported scores) as those treated with antibiotics without an increase in recurrence or complications. Primary Objective To determine whether antibiotic administration results in a difference in length of hospital stay when compared to a placebo. Secondary Objectives To determine whether antibiotic administration results in a difference in; patient-reported symptom scores, length of stay, occurrence of complications, readmission within 30 days, symptoms of AD, and serum markers of inflammation when compared with patients receiving placebo.

Interventions

The intervention group will receive intravenous antibiotics followed by oral antibiotics. Intravenous regimen (to commence following CT confirmation of uncomplicated AD, until afebrile for 24 hours) Cefuroxime 750mg intravenous, every 8 hours Metronidazole 500mg intravenous, every 8 hours Oral antibiotics (on discharge or once afebrile for 24 hours) Augmentin 625mg per oral, three times a day for 5-7 days -patients will be telephoned at 30 days and adherence will be examined at this time

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age > 18 years. 2. Current inpatient under the General Surgery service 3. Diagnosed with uncomplicated acute diverticulitis on CT scan within 24 hours of admission

Exclusion criteria

1. Pregnancy. 2. Previous allergic reaction with cefuroxime, metronidazole or amoxicillin/clavulanic acid use 3. Steroid or immunomodulator use for more than 5 days prior to presentation 4. Greater than 1 week of regular, non-steroidal anti-inflammatory drug use prior to presentation 5. Inflammatory bowel disease 6. ASA of 4 or greater 7. CT evidence of complicated disease 8. Meets criteria for a diagnosis of SIRS

Outcome results