Randomized clinical trial to compare the treatment of mild acute diverticulitis with or without antibiotics

Phase 1

• Conditions: Mild acute diverticulitis; MedDRA version: 19.0Level: LLTClassification code 10052812Term: Acute diverticulitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-001596-75-ES
• Lead Sponsor: Fundació Parc Taulí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-05
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age between 18 and 80 years old
Patients with acute diverticulitis grade 0 according to the modified Neff classification
Absence of acute diverticulitis episode in the previous 3 months
No treatment with antibiotics for any reason within the previous 2 weeks
Absence of relevant comorbidities
Patients giving their informed consent to participate in the study. Adecuate cognitive functions
Good family support
Good symptom control at emergency room
Oral tolerance
Immunocompetent patients
Maximum, one of the forllowing criteria: SIRS (T >38ºC or <36ºC, L >12000 or <4000/uL, Fc >90bpm, Fr >20rpm) or PCR >15mg/dL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

Pregnant or breast feeding women
Younguer than 18 years or older than 80 years
Patients with acute diverticulitis grade I or more according to the Neff classification
Acute diverticulitis episode within the last 3 months
Imflammatory Bowel Disease
Atibiotic intake in the previous 2 weeks
Presence of relevant comorbidities
Contraindications or alergy to any of the study treatments (amoxicillin-clavulanic, parecetamol, ibuprofen, omeprazol)
Patients unable to give their informed consent freely. Unadequate cognitive function
absence of good family support
Bad symptom control at emergency room
Bad oral tolerance
Immunosupression
More than one of the following criteria: SIRS (T >38ºC o <36ºC, L >12000 o <4000/uL, Fc >90bpm, Fr >20rpm) o PCR >15mg/dL

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if treatment of non complicated acute diverticulitis without antibiotic is non inferior to treatment woth antibiotic in terms of readmission rate;Secondary Objective: Assess differences between groups in number and reason of reconsultation<br>Assess differences between groups in the reasons for readmission (insufficient control, radiological progression, analytical worsening)<br>Assess diverences between groups in pain control (VAS) after 48 hours, 1 week, 1 month and 3 months<br>Assess differences between treatments in terms of recovery after 48 hours, 1 week, 1 month and 3 months <br>Describe complications for both treatment groups (percutaneous drainage, antibiotic use, urgent sigmoidectomy)<br>Describe and compare between groups adverse events related with study medication;Primary end point(s): Percentage of patients readmitted from emergency room discharge to 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percentage and reasons for reconsulting<br>Reasons for readmission: insufficient symptom control, complications.<br>Type of complications and treatment<br>Pain intensity (48 hours, 1 week, 4 weeks, 12 weeks)<br>Percentage of patients with free diet at 12 weeks<br>Percentage of patients free of symptoms at 48 hours and 1 week<br>Frequency of adverse events related with the study medication;Timepoint(s) of evaluation of this end point: 48 hours, 1 week, 4 weeks, 12 weeks