InfectionNCT03551847
The Effect of Oral Antibiotics on Synovial Fluid and Differential for the Diagnosis of Infection
A study testing Antibiotic and No antibiotics in people with Infection, run by Rush University Medical Center at 1 site in United States.
Trial summary
Periprosthetic joint infection 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Antibiotic and No antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2011to 5 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inadequate preoperative or intraoperative synovial fluid sample to perform synovial fluid WBC, %PMN and aerobic/anaerobic cultures.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University medical Center
Chicago, Illinois, 60612
About this study
Official title: The Effect of Oral Antibiotics on Synovial Fluid Leukocyte Count and Differential for the Diagnosis of Periprosthetic Hip and Knee Infection
Periprosthetic joint infection 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. Multiple studies have shown the high diagnostic accuracy of synovial fluid white blood cell count (WBC) and neutrophil percentage (%PMNs) in detecting PJI. This study's goal is to evaluate how antibiotics affect those two important diagnostic measures.
Read the 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.
- Conditions
- Infection
- Being tested
- Antibiotic, No antibiotics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
The intervention involves giving an infected patient antibiotics.
No antibioticsDrug
The intervention involves not giving an infected patient antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Oral antibiotic therapy group | Experimental | This group will receive preoperative oral antibiotic therapy tailored to the infecting organism (if identified) for two weeks before the time of revision surgery Receives: Drug: Antibiotic |
| No antibiotic therapy group | Active comparator | This group will not receive preoperative oral antibiotic therapy. Receives: Drug: No antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in synovial fluid white blood cell count with antibiotic treatment
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.
Measured: pre-operative to intraoperative
A change in synovial fluid neutrophil percentage with antibiotic treatment
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.
Measured: pre-operative to intraoperative
Secondary outcomes (1)
A change in culture results with antibiotic treatment
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.
Measured: pre-operative to intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Jul 2011
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Why it stopped: Unable to enroll any subjects, closed study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Della Valle, MD, Principal investigator, Professor of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551847
- Sponsor's protocol ID
- 16071701
- Status last verified
- Aug 2021
- First submitted
- 26 Oct 2017
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Antibiotics on Synovial Fluid Leukocyte Count and Differential for the Diagnosis of Periprosthetic Hip and Knee Infection
- ClinicalTrials.gov ID
- NCT03551847
- Acronym / sponsor ID
- 16071701
- Conditions
- Infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll any subjects, closed study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 11 Jun 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.
Periprosthetic joint infection 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. Multiple studies have shown the high diagnostic accuracy of synovial fluid white blood cell count (WBC) and neutrophil percentage (%PMNs) in detecting PJI. This study's goal is to evaluate how antibiotics affect those two important diagnostic measures.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral antibiotic therapy group | Experimental | Drug: AntibioticThis group will receive preoperative oral antibiotic therapy tailored to the infecting organism (if identified) for two weeks before the time of revision surgery |
| No antibiotic therapy group | Active comparator | Drug: No antibioticsThis group will not receive preoperative oral antibiotic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inadequate preoperative or intraoperative synovial fluid sample to perform synovial fluid WBC, %PMN and aerobic/anaerobic cultures.
- Pregnant women.
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 |
|---|---|---|
| AntibioticThe intervention involves giving an infected patient antibiotics. | Drug | Oral antibiotic therapy group |
| No antibioticsThe intervention involves not giving an infected patient antibiotics. | Drug | No antibiotic therapy group |
Primary outcome
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.
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.
1 secondary outcome
A change in culture results with antibiotic treatment
Time frame: pre-operative to intraoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- 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.
Craig Della Valle, MD principal investigator
Professor of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic and No antibiotics in people with Infection, run by Rush University Medical Center at 1 site in United States.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Aug 2021. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
A change in synovial fluid white blood cell count with antibiotic treatment (time frame: pre-operative to intraoperative). 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?
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 23 Aug 2021.