ErysipelasPhase 4SHARENCT01059123
Short Course of Amoxicillin for Erysipelas
A Phase 4 study testing Amoxicillin in people with Erysipelas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. This trial will be open but evaluation will be perform by a blind evaluator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erysipelas
- What is being tested?
- Amoxicillin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Jul 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age
- First episode of erysipelas of a lower leg defined as
- acute well delineate inflammation than had lasted less than 5 days
- T°≥ 38°5 at least once during the past 5 days or chills.
- Score ≥3 : oedema, erythema, pain each scored from 0 to 3 : 0= none, 1= moderate, 3= severe
- Written informed consent provided by the patient
- available health insurance
- accept conditions of the trial
Who cannot join
- Erysipelas for more than 5 days
- Score < 3
- Septic shock
- Clinical signs of necrotizing cellulitis or fasciitis, bullous lesions related to necrosis, purpuric lesions or superficial cutaneous necrosis.
- Past history of erysipelas of the same lower leg
- Erysipelas not on the lower leg
Show all 19Show fewer
- Bilateral erysipelas
- Bite occuring during the preceding 7 days.
- Diabetic foot
- patients who have previously received systemic antibiotherapy within the last 5 days (except one or two doses within last 24 hours)
- History of any hypersensitivity or allergic reaction to beta-lactam drugs
- Known renal or Hepatic failure
- Known HIV infection
- Female patients who are pregnant, lactating (breast milk feeding), or who are of child bearing potential and not using an acceptable method of birth control
- Impossibility to stop immunosuppressive treatment, systemic corticosteroids or nonsteroidal anti-inflammatory drugs.
- Severe gastrointestinal disease, dysphagia or any pathology preventing oral administration of treatment.
- Denied to sign written informed consent
- Unable or unwilling to adhere to the study-specified procedures and restrictions
- Evolutive cancer under treatment
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Henri Mondor - Service de dermatologie
Créteil, Île-de-France Region, 94000
About this study
Official title: Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas
The propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. This trial will be open but evaluation will be perform by a blind evaluator.
Read the detailed description
To fight against increasing rate of bacterial resistance to antibiotics, several studies have demonstrated efficacy of short antibiotic course in e.g. acute streptococcal tonsillitis, community acquired pneumonia, and urinary tract infection. Erysipelas is an acute dermo-hypodermal infection due to streptococcus. To date no resistance of theses bacteria to amoxicillin was described. The diagnosis of erysipelas is clinical. Thus, short course of antibiotic is a good regimen to test in erysipelas treatment. To date there is no controlled trial concerning efficacy of oral amoxicillin in erysipelas treatment. Expected advantages of the demonstration of the non inferiority of a short and oral amoxicillin treatment in erysipelas are: reduction of antibiotic selective pressure, cost, adverse events caused by infusion and hospitalisation.
- Conditions
- Erysipelas
- Being tested
- Amoxicillin
- Keywords
- Amoxicillin, Erysipelas, Short course
- Medical subject headings
- Erysipelas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
50 mg/kg/24H ; Per Os ; 3 times/day 6 days
AmoxicillinDrug
50 mg/kg/24H in I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; Per Os ; 3 times/day up to day 14.
| Study group | Role | What they receive |
|---|---|---|
| 1:Short treatment | Experimental | amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days. Receives: Drug: Amoxicillin |
| 2:Usual treatment | Active comparator | amoxicillin 50 mg/kg/24H ; I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day up to day 14. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)
Measured: Day 30 ± 5
Secondary outcomes (4)
Time to obtain disappearance of fever and local signs
Measured: up to day 30 ± 5
Relapse rate
Measured: end of treatment to day 30± 5
Recurrence rate
Measured: day 30± 5 to day 95± 5
Frequency of adverse events
Measured: 30 days ± 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Insufficient number of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErysipelasStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Société de Dermatologie Française
- Responsible party
- Sponsor
- Investigators
- Olivier CHOSIDOW, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059123
- Sponsor's protocol ID
- P071207
- Other IDs
- 2008-006794-32, 2008
- Acronym
- SHARE
- Status last verified
- Feb 2014
- First submitted
- 28 Jan 2010
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas
- ClinicalTrials.gov ID
- NCT01059123
- Acronym / sponsor ID
- SHARE / P071207
- Conditions
- Erysipelas
- Keywords
- Amoxicillin, Erysipelas, Short course
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient number of inclusion
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Société de Dermatologie Française
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Jan 2010 (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.
The propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. This trial will be open but evaluation will be perform by a blind evaluator.
Detailed description
To fight against increasing rate of bacterial resistance to antibiotics, several studies have demonstrated efficacy of short antibiotic course in e.g. acute streptococcal tonsillitis, community acquired pneumonia, and urinary tract infection. Erysipelas is an acute dermo-hypodermal infection due to streptococcus. To date no resistance of theses bacteria to amoxicillin was described. The diagnosis of erysipelas is clinical. Thus, short course of antibiotic is a good regimen to test in erysipelas treatment. To date there is no controlled trial concerning efficacy of oral amoxicillin in erysipelas treatment. Expected advantages of the demonstration of the non inferiority of a short and oral amoxicillin treatment in erysipelas are: reduction of antibiotic selective pressure, cost, adverse events caused by infusion and hospitalisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1:Short treatment | Experimental | Drug: Amoxicillinamoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days. |
| 2:Usual treatment | Active comparator | Drug: Amoxicillinamoxicillin 50 mg/kg/24H ; I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day up to day 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females ≥ 18 years of age
- First episode of erysipelas of a lower leg defined as
- Written informed consent provided by the patient
- available health insurance
- accept conditions of the trial
Key exclusion criteria (19 listed)
- Erysipelas for more than 5 days
- Score < 3
- Septic shock
- Clinical signs of necrotizing cellulitis or fasciitis, bullous lesions related to necrosis, purpuric lesions or superficial cutaneous necrosis.
- Past history of erysipelas of the same lower leg
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 |
|---|---|---|
| Amoxicillin50 mg/kg/24H ; Per Os ; 3 times/day 6 days | Drug | 1:Short treatment |
| Amoxicillin50 mg/kg/24H in I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; Per Os ; 3 times/day up to day 14. | Drug | 2:Usual treatment |
Primary outcome
Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)
Time frame: Day 30 ± 5
4 secondary outcomes
Time to obtain disappearance of fever and local signs
Time frame: up to day 30 ± 5
Relapse rate
Time frame: end of treatment to day 30± 5
Recurrence rate
Time frame: day 30± 5 to day 95± 5
Frequency of adverse events
Time frame: 30 days ± 5
Results and safety
The study was stopped early (reason given: Insufficient number of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
Related trials for Erysipelas
Not yet recruitingPhase 4
Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy.
Recurrent Erysipelas
Not yet recruitingPhase 4
Comparing Short to Standard Amoxicillin Course for Erysipelas
Erysipelas
Recruiting
Hospital at Home for Elderly Acute Ill Patients
Cystitis, Erysipelas
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.
Olivier CHOSIDOW, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 in people with Erysipelas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 7 Feb 2014. 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 France. 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 was stopped early (reason given: Insufficient number of inclusion). Results are not available in the source record.
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?
Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o) (time frame: Day 30 ± 5). 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 7 Feb 2014.