Arthritis, SepticNCT03615781
Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis
A study testing Two week's arm - surgery, Four week's arm - surgery and Two week's arm - drugs in people with Arthritis, Septic, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allowing up to 3 surgical lavages and allocating patients into a two-week's and a four week's randomization arm Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Arthritis, Septic
- What is being tested?
- Two week's arm - surgery, Four week's arm - surgery and Two week's arm - drugs
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2015to 18 May 2018
- Phase
- Interventional
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >17 years
- Microbiologically-confirmed septic arthritis
- At least one surgical drainage/lavage
Who cannot join
- Presence of osteosynthesis material in the vicinity of the articulation
- Presence of a concomitant infection needing more than 2 week's of antibiotic therapy
- More than 3 surgical drainages
- Life expectancy less than 6 months
- Chronic osteomyelitis in vicinity of the arthritis
Trial locations and contacts
1 site in 1 country.
About this study
The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allowing up to 3 surgical lavages and allocating patients into a two-week's and a four week's randomization arm
Read the detailed description
The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allocating patients into a two-week's and a four week's randomization arm.
The adult patients are hospitalized for septic arthritis. A computer program randomizes 1:1 between a two week's and a four week's arm of targeted antibiotic treatment of which at least the first week is intravenously. The randomization may occur until Day 5 of admission. Up to three surgical interventions are allowed. The investigators allow the inclusion of all bacterial arthritis and all joints.
- Conditions
- Arthritis, Septic
- Being tested
- Two week's arm - surgery, Four week's arm - surgery, Two week's arm - drugs, Four week's arm - drugs
- Keywords
- septic arthritis, surgery, antibiotic duration, remission, sequelae
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two week's arm - surgeryProcedure or surgery
The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
Four week's arm - surgeryProcedure or surgery
The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
Two week's arm - drugsDrug
After the surgical implant removal, the investigators prescribe a total of 2 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.
Four week's arm - drugsDrug
After the surgical implant removal, the investigators prescribe a total of 4 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Two week's arm - surgery | Experimental | The investigators perform a surgical drainage and removal of the infected orthopedic implant. Receives: Procedure: Two week's arm - surgery |
| Four week's arm - surgery | Active comparator | The investigators surgically remove the infected implant. Receives: Procedure: Four week's arm - surgery |
| Two week's arm - drugs | Experimental | The investigators perform a surgical drainage and removal of the infected orthopedic implant. They start an empirical antibiotic treatment based on patient's history and co-morbidities, such as vancomycin or amoxicillin/clavulanic acid. The adapt later on the targeted antibiotic therapy according to the causative pathogens and their antibiotic susceptibility testing. Receives: Drug: Two week's arm - drugs |
| Four week's arm - drugs | Active comparator | The investigators surgically remove the infected implant and all soft tissue infection. Instead of a total of 2 week's of antibiotic therapy, they administer a total of 4 weeks of systemic antibiotic therapy targeted to the pathogen(s). Receives: Drug: Four week's arm - drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission of systemic infection
Measurement of fever.
Measured: 6 months
Sequels
Patient's remaining gait disorders.
- range of movement in adjacent joints of former infection
- questionnaire regarding persistant pain and handicaps (open wording)
Measured: 6 months
Secondary outcomes (3)
Wound redness
Visual examination of the presence of wound redness.
Measured: 6 months
Wound discharge
Visual examination of the presence of wound discharge
Measured: 6 months
Presence of pus
Visual examination of the presence of pus coming out the wound
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jun 2015
- Primary completion1 Apr 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, SepticStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Uckay, University Hospital, Geneva
- Investigators
- Ilker Uçkay, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615781
- Sponsor's protocol ID
- no. 15-014
- Status last verified
- Jul 2018
- First submitted
- 16 Jan 2017
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uckay I, Tovmirzaeva L, Garbino J, Rohner P, Tahintzi P, Suva D, Assal M, Hoffmeyer P, Bernard L, Lew D. Short parenteral antibiotic treatment for adult septic arthritis after successful drainage. Int J Infect Dis. 2013 Mar;17(3):e199-205. doi: 10.1016/j.ijid.2011.12.019. Epub 2012 Nov 22.
PubMed 23183231Gjika E, Beaulieu JY, Vakalopoulos K, Gauthier M, Bouvet C, Gonzalez A, Morello V, Steiger C, Hirsiger S, Lipsky BA, Uckay I. Two weeks versus four weeks of antibiotic therapy after surgical drainage for native joint bacterial arthritis: a prospective, randomised, non-inferiority trial. Ann Rheum Dis. 2019 Aug;78(8):1114-1121. doi: 10.1136/annrheumdis-2019-215116. Epub 2019 Apr 16.
PubMed 30992295
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis
- ClinicalTrials.gov ID
- NCT03615781
- Acronym / sponsor ID
- no. 15-014
- Conditions
- Arthritis, Septic
- Keywords
- septic arthritis, surgery, antibiotic duration, remission, sequelae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- 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 optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allowing up to 3 surgical lavages and allocating patients into a two-week's and a four week's randomization arm
Detailed description
The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allocating patients into a two-week's and a four week's randomization arm.
The adult patients are hospitalized for septic arthritis. A computer program randomizes 1:1 between a two week's and a four week's arm of targeted antibiotic treatment of which at least the first week is intravenously. The randomization may occur until Day 5 of admission. Up to three surgical interventions are allowed. The investigators allow the inclusion of all bacterial arthritis and all joints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Two week's arm - surgery | Experimental | Procedure: Two week's arm - surgeryThe investigators perform a surgical drainage and removal of the infected orthopedic implant. |
| Four week's arm - surgery | Active comparator | Procedure: Four week's arm - surgeryThe investigators surgically remove the infected implant. |
| Two week's arm - drugs | Experimental | Drug: Two week's arm - drugsThe investigators perform a surgical drainage and removal of the infected orthopedic implant. They start an empirical antibiotic treatment based on patient's history and co-morbidities, such as vancomycin or amoxicillin/clavulanic acid. The adapt later on the targeted antibiotic therapy according to the causative pathogens and their antibiotic susceptibility testing. |
| Four week's arm - drugs | Active comparator | Drug: Four week's arm - drugsThe investigators surgically remove the infected implant and all soft tissue infection. Instead of a total of 2 week's of antibiotic therapy, they administer a total of 4 weeks of systemic antibiotic therapy targeted to the pathogen(s). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >17 years
- Microbiologically-confirmed septic arthritis
- At least one surgical drainage/lavage
Key exclusion criteria (5 listed)
- Presence of osteosynthesis material in the vicinity of the articulation
- Presence of a concomitant infection needing more than 2 week's of antibiotic therapy
- More than 3 surgical drainages
- Life expectancy less than 6 months
- Chronic osteomyelitis in vicinity of the arthritis
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 |
|---|---|---|
| Two week's arm - surgeryThe investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant. | Procedure or surgery | Two week's arm - surgery |
| Four week's arm - surgeryThe investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant. | Procedure or surgery | Four week's arm - surgery |
| Two week's arm - drugsAfter the surgical implant removal, the investigators prescribe a total of 2 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously. | Drug | Two week's arm - drugs |
| Four week's arm - drugsAfter the surgical implant removal, the investigators prescribe a total of 4 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously. | Drug | Four week's arm - drugs |
Primary outcome
Clinical Remission of systemic infection
Time frame: 6 months
Measurement of fever.
Sequels
Time frame: 6 months
Patient's remaining gait disorders. * range of movement in adjacent joints of former infection * questionnaire regarding persistant pain and handicaps (open wording)
3 secondary outcomes
Wound redness
Time frame: 6 months
Wound discharge
Time frame: 6 months
Presence of pus
Time frame: 6 months
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 6 Aug 2018.
- Background: PubMed 23183231Uckay I, Tovmirzaeva L, Garbino J, Rohner P, Tahintzi P, Suva D, Assal M, Hoffmeyer P, Bernard L, Lew D. Short parenteral antibiotic treatment for adult septic arthritis after successful drainage. Int J Infect Dis. 2013 Mar;17(3):e199-205. doi: 10.1016/j.ijid.2011.12.019. Epub 2012 Nov 22.
- Derived from this study: PubMed 30992295Gjika E, Beaulieu JY, Vakalopoulos K, Gauthier M, Bouvet C, Gonzalez A, Morello V, Steiger C, Hirsiger S, Lipsky BA, Uckay I. Two weeks versus four weeks of antibiotic therapy after surgical drainage for native joint bacterial arthritis: a prospective, randomised, non-inferiority trial. Ann Rheum Dis. 2019 Aug;78(8):1114-1121. doi: 10.1136/annrheumdis-2019-215116. Epub 2019 Apr 16.
- Individual participant dataSharing planned: No
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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.
Ilker Uçkay, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two week's arm - surgery, Four week's arm - surgery and Two week's arm - drugs in people with Arthritis, Septic, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 inclusion and 5 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 6 Aug 2018. 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 Switzerland. 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.
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?
Clinical Remission of systemic infection (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615781, which also lists 2 linked publications.
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 6 Aug 2018.