Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis
DANC-05
Prospective Randomized Clinical Trial Assessing the Efficacy of a Short Course of Intravenous Amoxicillin Plus Clavulanic Acid Followed by Oral Antibiotic in Patients With Uncomplicated Acute Diverticulitis
1 other identifier
interventional
50
1 country
1
Brief Summary
Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an enormous diversity in clinical practice. The investigators' aim was to demonstrate that uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a short hospital admission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2005
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedSeptember 28, 2023
September 1, 2023
2.4 years
June 8, 2009
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
failure of treatment
the 4th day (group 1) or the 8th day (group 2)
Secondary Outcomes (1)
emergency admission or hospital readmission for reasons related to the previous diverticulitis
30 days after discharge
Study Arms (2)
Short intravenous amoxicillin plus clavulanic acid
EXPERIMENTALIntravenous antibiotic 48 hours followed by oral antibiotic for 10 days
Long intravenous amoxicillin plus clavulanic acid
ACTIVE COMPARATORIntravenous antibiotic for 7 days followed by oral antibiotic for 5 days
Interventions
intravenous amoxicillin plus clavulanic acid 1 gr every 8 hours 48 hours followed by oral amoxicillin plus clavulanic acid 1 gr every 8 hours for 10 days
Eligibility Criteria
You may qualify if:
- clinical diagnosis of uncomplicated acute diverticulitis confirmed by a computed tomography (CT) scan within 24-48 hours
You may not qualify if:
- immunocompromised patients
- pregnant women
- clinical suspicion or CT confirmation of complicated acute diverticulitis
- Karnofsky performance score less than 50%
- allergy to penicillin
- withdrawal of the trial
- CT confirmation of complicated acute diverticulitis
- CT not conforming to acute diverticulitis
- CT performed 72 hours after the admission
- adverse reaction to the antibiotic
- bacteriemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Consorci Sanitari de Terrassalead
- Corporacion Parc Taulicollaborator
Study Sites (1)
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yolanda Ribas, MD, PhD
Consorci Sanitari de Terrassa
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
December 1, 2005
Primary Completion
May 1, 2008
Study Completion
October 1, 2008
Last Updated
September 28, 2023
Record last verified: 2023-09