DiverticulitisPhase 4DANC-05NCT00917592
Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis
A Phase 4 study testing amoxicillin plus clavulanic acid in people with Diverticulitis, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diverticulitis
- What is being tested?
- amoxicillin plus clavulanic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2005to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of uncomplicated acute diverticulitis confirmed by a computed tomography (CT) scan within 24-48 hours
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic, with those who received intravenous antibiotic for a longer period. We included 50 patients, 25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of treatment" which was defined as the impossibility of discharging on the expected day, emergency admission or hospital readmission.
- Conditions
- Diverticulitis
- Being tested
- amoxicillin plus clavulanic acid
- Keywords
- Diverticulitis
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin plus clavulanic acidDrug
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
amoxicillin plus clavulanic acidDrug
intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Short intravenous amoxicillin plus clavulanic acid | Experimental | Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days Receives: Drug: amoxicillin plus clavulanic acid |
| Long intravenous amoxicillin plus clavulanic acid | Active comparator | Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days Receives: Drug: amoxicillin plus clavulanic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of treatment
Measured: 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
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startDec 2005
- Primary completionMay 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Responsible party
- Principal investigator, Yolanda Ribas, Consorci Sanitari de Terrassa
- Investigators
- Yolanda Ribas, MD, PhD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917592
- Sponsor's protocol ID
- DANC-05
- Acronym
- DANC-05
- Status last verified
- Sep 2023
- First submitted
- 8 Jun 2009
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00917592
- Acronym / sponsor ID
- DANC-05 / DANC-05
- Conditions
- Diverticulitis
- Keywords
- Diverticulitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Study start
- Dec 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic, with those who received intravenous antibiotic for a longer period. We included 50 patients, 25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of treatment" which was defined as the impossibility of discharging on the expected day, emergency admission or hospital readmission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short intravenous amoxicillin plus clavulanic acid | Experimental | Drug: amoxicillin plus clavulanic acidIntravenous antibiotic 48 hours followed by oral antibiotic for 10 days |
| Long intravenous amoxicillin plus clavulanic acid | Active comparator | Drug: amoxicillin plus clavulanic acidIntravenous antibiotic for 7 days followed by oral antibiotic for 5 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of uncomplicated acute diverticulitis confirmed by a computed tomography (CT) scan within 24-48 hours
Key exclusion criteria (11 listed)
- immunocompromised patients
- pregnant women
- clinical suspicion or CT confirmation of complicated acute diverticulitis
- Karnofsky performance score less than 50%
- allergy to penicillin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amoxicillin plus clavulanic acidintravenous 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 | Drug | Long intravenous amoxicillin plus clavulanic acid, Short intravenous amoxicillin plus clavulanic acid |
| amoxicillin plus clavulanic acidintravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days | Drug | Long intravenous amoxicillin plus clavulanic acid, Short intravenous amoxicillin plus clavulanic acid |
Primary outcome
failure of treatment
Time frame: the 4th day (group 1) or the 8th day (group 2)
1 secondary outcome
emergency admission or hospital readmission for reasons related to the previous diverticulitis
Time frame: 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda Ribas, MD, PhD principal investigator
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amoxicillin plus clavulanic acid in people with Diverticulitis, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure of treatment (time frame: the 4th day (group 1) or the 8th day (group 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.