- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551847
The Effect of Oral Antibiotics on Synovial Fluid and Differential for the Diagnosis of Infection
The Effect of Oral Antibiotics on Synovial Fluid Leukocyte Count and Differential for the Diagnosis of Periprosthetic Hip and Knee Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Periprosthetic joint infection (PJI) following total hip or knee arthroplasty is a rare but potentially devastating complication. Accurate diagnosis of these infections remains one of the most challenging undertakings in orthopaedics. Clinical presentation of PJI may be subtle and distinguishing between infection versus aseptic issues can be difficult. Currently no diagnostic approach has been developed that accurately and unequivocally diagnoses PJI.
Multiple studies have shown the high diagnostic accuracy of synovial fluid white blood cell count (WBC) and neutrophil percentage (%PMNs) in detecting PJI. This has led to incorporation of these two parameters into criteria for the diagnosis of PJI. WBC and %PMN cutoffs have been published for prosthetic hips and knees in both the acute and chronic setting. Meanwhile, synovial fluid cell counts are believed to be of particular value when patients present on systemic antibiotics, which have been shown to compromise intraarticular cultures by causing false negative results.
However, the effect of antibiotics on synovial fluid cell count and differential has not been well delineated. One prospective study by Trampuz et al. of 133 synovial fluid specimens prior to total knee revisions noted that patients receiving antimicrobial agents had lower leukocyte counts than did those who were not receiving antimicrobial agents. To the contrary, a recent animal study examined intra-articular administration of the antibiotic amikacin in horses and reported a statistically significant increase in the synovial nucleated cell count. The effect of antibiotics on synovial fluid WBC and %PMN thus remains unclear.
Furthermore, to reduce false-negative culture results, it is recommended that patients be off of antibiotics for a minimum of two weeks prior to obtaining samples for culture. Investigators have shown reduced false-negative culture rates in patients not taking antibiotics prior to surgery compared to those taking antibiotics at the time of surgery. However, the two-week time interval is relatively arbitrary and adequate supporting data do not exist.
The primary aim of this study is to evaluate how antibiotics affect synovial fluid leukocyte and differential counts. A secondary aim is to assess how long patients need to be off of antibiotic therapy to generate accurate synovial fluid cultures. Further examination of the effects of systemic antibiotics on synovial fluid composition will provide valuable information for clinicians caring for patients with possible PJI.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient>18 years old.
- Patient with a prosthetic hip or knee in place.
- Patient with PJI of the hip or knee based on MSIS criteria3(Table 1).
- Patient off of antibiotics for a minimum of two weeks prior to preoperative joint aspiration.
- Patient with a culture-positive preoperative joint aspiration
Exclusion Criteria:
- Inadequate preoperative or intraoperative synovial fluid sample to perform synovial fluid WBC, %PMN and aerobic/anaerobic cultures.
- Pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral antibiotic therapy group
This group will receive preoperative oral antibiotic therapy tailored to the infecting organism (if identified) for two weeks before the time of revision surgery
|
The intervention involves giving an infected patient antibiotics.
|
Active Comparator: No antibiotic therapy group
This group will not receive preoperative oral antibiotic therapy.
|
The intervention involves not giving an infected patient antibiotics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A change in synovial fluid white blood cell count with antibiotic treatment
Time Frame: pre-operative to intraoperative
|
White blood cell count will be measured from synovial fluid.
This fluid will be sent to our in-house laboratory testing facility.
WBC is measured as the total number per mL of fluid.
|
pre-operative to intraoperative
|
A change in synovial fluid neutrophil percentage with antibiotic treatment
Time Frame: pre-operative to intraoperative
|
Neutrophil percentage will be measured from synovial fluid.
This fluid will be sent to our in-house laboratory testing facility.
%PMN is a percentage out of total white blood cell count.
|
pre-operative to intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A change in culture results with antibiotic treatment
Time Frame: pre-operative to intraoperative
|
Synovial fluid will be sent to our in-house lab and they will try and grow cultures from this fluid to see if they can identify the organism causing the infection.
|
pre-operative to intraoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Craig Della Valle, MD, Professor of Orthopaedic Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16071701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infection
-
West Virginia UniversityEnrolling by invitationSkin and Soft Tissue Infection | Gastrointestinal Infection | Pulmonary Infection | Bone and Joint Infection | Endovascular Infection | Genitourinary InfectionUnited States
-
Ondine Biomedical Inc.CompletedSurgical Site Infection | Nosocomial Infection | Healthcare Associated InfectionUnited States
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site Infection | Superficial Surgical Site Infection | Deep Surgical Site Infection | Organ/Space Surgical Site InfectionUnited States
-
Croydon Health Services NHS TrustCompletedSurgical Site Infection | Wound Infection | Cesarean Section; Infection | Perineal InfectionUnited Kingdom
-
Cairo UniversityRecruitingPostoperative Infection | Cesarean Section Complications | Vaginal InfectionEgypt
-
Vastra Gotaland RegionGöteborg UniversityRecruitingProsthetic Joint Infection | Hip Prosthesis Infection | Prosthetic Infection | Knee Prosthesis InfectionSweden
-
University of ZurichRecruitingProsthetic Joint Infection | Surgical Site Infection | Prosthesis and Implants | Postoperative Wound Infection Deep Incisional Surgical SiteSwitzerland
-
Ondine Biomedical Inc.CompletedNosocomial Infection | Surgical Site Infections | Healthcare Associated InfectionsUnited States
-
Duke UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedSurgical Site Infection | Infection ControlUnited States
-
Angela BiancoStryker NordicTerminatedCesarean Section | Surgical Site Infection | Nosocomial InfectionUnited States
Clinical Trials on Antibiotic
-
Mahidol UniversityCompletedBacteriuria | Kidney Transplantation | Asymptomatic InfectionsThailand
-
The Cleveland ClinicCompletedOveractive Bladder | Urge Incontinence | Urinary Incontinence, Urge | Overactive Bladder SyndromeUnited States
-
Ruijin HospitalNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingKidney Transplant Infection | Pyelonephritis AcuteFrance
-
University of Geneva, SwitzerlandCentre Hospitalier Universitaire Vaudois; Cantonal Hospital of St. GallenCompletedBacteraemia Caused by Gram-Negative BacteriaSwitzerland
-
Thomas BenfieldRecruitingUrinary Tract Infection Bacterial | Gram-negative BacteremiaDenmark
-
Spanish Society of Family and Community MedicineCompletedRespiratory Tract Infections | Infectious DiseasesSpain
-
Assistance Publique - Hôpitaux de ParisBioMérieuxRecruiting
-
Nantes University HospitalRecruitingVentilator Associated Pneumonia | Critical Care | Antibiotic TherapyFrance
-
ARCIM Institute Academic Research in Complementary...Gemeinschaftskrankenhaus Herdecke, GermanyRecruitingCommunity Acquired Pneumonia in Children | Antibiotic StewardshipGermany