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Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02785549
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Neus Ruiz-Edo, Corporacion Parc Tauli

Brief Summary:
Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.

Condition or disease Intervention/treatment Phase
Acute Diverticulitis Drug: Ibuprofen Drug: Acetaminophen Drug: Amoxicillin/clavulanic acid Phase 4

Detailed Description:

In the last years, traditional pathologic mechanisms of acute diverticulitis are being questioned and replaced by more scientifically grounded hypotheses that strongly postulate an inflammatory origin. Local pro-inflammatory cytokines, microbiota shifts, disturbed neurological intestinal signalling due to alterations in colonic neuropeptides and abnormal colonic motility are all being proposed as potential etiologic factors. Recent publications, therefore, call into question the benefits of antibiotic treatment or episodes of acute diverticulitis, especially for mild episodes. Furthermore, recent international guidelines endorse this stance in their recommendations. Moreover, recent studies provide evidence regarding the security of treating patients with mild acute diverticulitis as outpatients.

The investigators think that outpatient treatment without antibiotic for mild acute diverticulitis is not-inferior to traditional treatment with antibiotic, measuring the efficacy with readmission ratio. For this reason we have designed a multicentric, randomised, prospective study.

All patients seen in the emergency department with clinical signs of acute diverticulitis (left iliac fossa abdominal pain, peritoneal irritation signs and/or leucocytosis) will undergo an abdominal computed tomography to confirm the diagnosis and grade the disease according to severity using the modified Neff (mNeff) classification. Those with mild acute diverticulitis (grade 0), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.

Primary goal is to determine if, in mild acute diverticulitis, the treatment without antibiotic is not-inferior to the traditional treatment with antibiotic considering readmission ratio.

Secondary goals include the analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation, reason for readmission (bad symptoms control, radiologic progression, analysis worsening), pain control (analogic visual scale), recuperation after the acute episode, complication rate and their treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre Controlled, Randomized Clinical Trial to Compare the Efficacy and Safety of Ambulatory Treatment of Mild Acute Diverticulitis Without Antibiotics With the Standard Treatment With Antibiotics
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Symptomatic treatment with NSAID
1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen
Drug: Ibuprofen
600 mg/8hours

Drug: Acetaminophen
1 g/8 hours
Other Name: Paracetamol

Active Comparator: Antibiotic+symptomatic treatment with NSAID
875/125mg /8h amoxicillin/clavulanic acid and symptomatic treatment with 1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen
Drug: Ibuprofen
600 mg/8hours

Drug: Acetaminophen
1 g/8 hours
Other Name: Paracetamol

Drug: Amoxicillin/clavulanic acid
875mg/125mg/8 hours




Primary Outcome Measures :
  1. Readmission ratio [ Time Frame: 3 months ]
    Primary outcome is to determine if, in mild acute diverticulitis, the treatment without antibiotic is not-inferior to the traditional treatment with antibiotic considering readmission ratio.


Secondary Outcome Measures :
  1. Reconsultation ratio [ Time Frame: 3 months ]
    The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation

  2. Reason for reconsultation [ Time Frame: 3 months ]
    The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation

  3. Reason for readmission [ Time Frame: 3 months ]
    The analysis of the differences between groups, in case there are, in relation to reason for readmission (bad symptoms control, radiologic progression, analysis worsening)

  4. Pain control [ Time Frame: 48 hours, 7 days, 1 month, 3 months ]
    The analysis of the differences between groups, in case there are, in relation to pain control (analogic visual scale), during follow-up.

  5. Complications [ Time Frame: 3 months ]
    Description of the complications in both groups (perforation, abscess) and its treatment (percutaneous drainage, emergency surgery, broad spectrum antibiotics)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's written informed consent. Adequate cognitive capacity.
  • Adequate family support
  • No acute diverticulitis episode in the last 3 months
  • mNeff 0 acute diverticulitis (abdominal computed tomography scan)
  • No antibiotic treatment in the last 2 weeks
  • Immunocompetence*
  • No significant comorbidities**
  • Good oral tolerance
  • Good symptom control
  • Maximum one of the following SIRS criteria (* T>38 ºC or <36ºC, L>12,000 or <4000/uL, HR>90 bpm, RR<20 rpm) or CRP>15 mg/dL

Exclusion Criteria:

  • Women in pregnancy or breastfeeding
  • Age <18 years or > 80 years.
  • Absence of the patient's written informed consent. Inadequate cognitive capacity.
  • Inadequate family support
  • Acute diverticulitis episode in the last 3 months
  • Moderate acute diverticulitis (mNeff grade I or upper)
  • Antibiotic treatment in the last 2 weeks
  • Inflammatory bowel disease
  • Immunodepression*
  • Presence of significant comorbidities**
  • Bad oral tolerance
  • Poor symptom control
  • More than one of the following SIRS criteria (* T>38 ºC or <36ºC, L>12,000 or <4000/uL, HR>90 bpm, RR<20 rpm) or CRP>15 mg/dL

(*) Immunocompetence is the absence and immunodepression is the presence of any of the following: active neoplastic disease/hematologic malignancy/HIV with low CD4+ count/long-term corticosteroid treatment/immunosuppressant therapy/transplant/splenectomy/genetic immunodeficiency.

(**) We consider significant comorbidities any of the following: poorly controlled diabetes mellitus (HbA1>7mg/dl), cardiologic event in the last 3 months, decompensation of hepatopathy in the last 3 months, renal chronic insufficiency in dialysis programme.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785549


Contacts
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Contact: Neus Ruiz, MD Mnruiz@tauli.cat

Locations
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Spain
Corporació Sanitària Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: NEUS RUIZ    0034937231010 ext 21490    mnruiz@tauli.cat   
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Laura Mora, MD PhD Corporacion Parc Tauli

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Neus Ruiz-Edo, MD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02785549    
Other Study ID Numbers: CIR-DISA-2016
2016-001596-75 ( EudraCT Number )
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Neus Ruiz-Edo, Corporacion Parc Tauli:
Acute diverticulitis
Antibiotic
Outpatient treatment
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Acetaminophen
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Ibuprofen
Anti-Infective Agents
Antitubercular Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors