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Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03615781
Enrollment
85
Registered
2018-08-06
Start date
2015-06-01
Completion date
2018-05-18
Last updated
2018-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Septic

Keywords

septic arthritis, surgery, antibiotic duration, remission, sequelae

Brief 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

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.

Interventions

PROCEDURETwo week's arm - surgery

The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.

PROCEDUREFour week's arm - surgery

The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.

DRUGTwo week's arm - drugs

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.

DRUGFour week's arm - drugs

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.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

1. Age \>17 years 2. Microbiologically-confirmed septic arthritis 3. At least one surgical drainage/lavage

Exclusion criteria

1. Presence of osteosynthesis material in the vicinity of the articulation 2. Presence of a concomitant infection needing more than 2 week's of antibiotic therapy 3. More than 3 surgical drainages 4. Life expectancy less than 6 months 5. Chronic osteomyelitis in vicinity of the arthritis

Design outcomes

Primary

MeasureTime frameDescription
Clinical Remission of systemic infection6 monthsMeasurement of fever.
Sequels6 monthsPatient's remaining gait disorders. * range of movement in adjacent joints of former infection * questionnaire regarding persistant pain and handicaps (open wording)

Secondary

MeasureTime frameDescription
Wound redness6 monthsVisual examination of the presence of wound redness.
Wound discharge6 monthsVisual examination of the presence of wound discharge
Presence of pus6 monthsVisual examination of the presence of pus coming out the wound

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026