Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

Arthritis, Septic Clinical Trial

Official title:

Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615781
• Other study ID #: no. 15-014
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: May 18, 2018

Study information

• Verified date: July 2018
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 18, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Arthritis, Septic

Intervention

Procedure:
• Two week's arm - surgery
The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
• Four week's arm - surgery
The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.

Drug:
• Two 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.
• Four 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.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Uçkay I, Tovmirzaeva L, Garbino J, Rohner P, Tahintzi P, Suvà 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission of systemic infection	Measurement of fever.	6 months
Primary	Sequels	Patient's remaining gait disorders.; range of movement in adjacent joints of former infection; questionnaire regarding persistant pain and handicaps (open wording)	6 months
Secondary	Wound redness	Visual examination of the presence of wound redness.	6 months
Secondary	Wound discharge	Visual examination of the presence of wound discharge	6 months
Secondary	Presence of pus	Visual examination of the presence of pus coming out the wound	6 months