Prosthetic Joint InfectionNCT02413034
The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures
A study testing Cefazolin in people with Prosthetic Joint Infection, run by Parc de Salut Mar.
Trial summary
Total joint replacement is a common clinical practice for patients suffering from disabling arthritis, since it provides significant pain relief and functional recovering. Nevertheless, its outcome is compromised by complications such as periprosthetic joint infection (PJI), which is reported to occur in 1 to 4% of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- Cefazolin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All the patients diagnosed with PJI who meet Zimmerli criteria and undergo a first-stage exchange, or débridment and retention procedure, in case there is an acute infection. These criteria are: visible sinus tract or purulence surrounding the prosthesis; detection of an infecting microorganism in the synovial fluid aspiration samples, intraoperative tissue and/or fluid cultures; synovial white blood cell count and histopathology parameters. The investigators will also include an additional criterion, which is prosthetic loosening 2 years after primary arthroplasty implantation following recent Portillo findings.
- The investigators will include hip, knee and shoulder replacements.
Who cannot join
- Patients receiving any kind of antibiotic regimen during the previous week of surgery;
- Hemodynamically unstable patients in need of antibiotic therapy, previously to the surgery.
About this study
Total joint replacement is a common clinical practice for patients suffering from disabling arthritis, since it provides significant pain relief and functional recovering. Nevertheless, its outcome is compromised by complications such as periprosthetic joint infection (PJI), which is reported to occur in 1 to 4% of primary total knee arthroplasties (TKA), and approximately 1% of primary total hip replacements (THR). Despite all efforts to restrain PJI, its prevalence may reach even higher proportions if patients undergo a resection arthroplasty or irrigation and débridement for infected prosthesis. That said, timely diagnosis and early isolation of the infected microorganism is utterly important, if proper care is to be delivered.
The gold standard for the diagnosis of PJI is the isolation of a microorganism from the intraoperative cultures, combined with the sonication from retrieved joint implants1. This technique applies sound energy to agitate and disrupt biofilm, dislodging adherent bacterias to the bone cement, which has been proved to be a more sensitive method than conventional intraoperative cultures. False-negative percentages were reported to be 15% in patients who did not receive extended antibiotic prophylaxis and 60% if extended antibiotic therapy was administered.
Read more
Regardless of an adequate clinical, radiographic and surgical suspicion confirming PJI, an organism is not always successfully isolated from the intraoperative cultures, which increases false negatives results. This fact has been trying to be explained by several authors, some of which postulate that antibiotic prophylaxis could interfere with the isolation of the microorganism from the intraoperative cultures. As a result, and acting accordingly to this hypothesis, preoperative antibiotics are often withheld until intraoperative cultures are obtained, hoping that tissues are not loaded with antibiotics. Nevertheless, one should be aware of the adverse consequences of this practice that may result in systemic dissemination of infection.
Moreover, Ghanem and Stephen recently concluded that antibiotic prophylaxis does not interfere with the isolation of the microorganism from intraoperative cultures, despite being studies that lack statistical power.
Therefore, it is clear that reported studies in this field support both preoperative antibiotic prophylaxis administration, as well its withdrawal, until intraoperative cultures are obtained.
This decision in the department study depends exclusively on the treating surgeon judgment. In fact, 48% of all patients admitted at the study hospital with PJI receive preoperative antibiotic prophylaxis, which could be related to higher false-negative intraoperative culture and sonication results. Thus, the investigators add substances with chelation properties to hemoculture containers and then inoculate sonication samples. This practice offsets antibiotic interference with intraoperative cultures and has proved to enhance microorganism detection rates.
That said, and given the lack of scientific evidence about this clinical practice the investigators are willing to engage a prospective randomized double-blind clinical trial, that will allow us to determine whether intraoperative cultures and sonication samples are affected by antibiotic prophylaxis.
Read the detailed description
AIM AND RATIONALE:
Hypothesis:
H0: Preoperative antibiotic prophylaxis in patients with PJI interferes with the isolation of the microorganism from the intraoperative cultures and sonication samples, resulting in higher false-negative results.
H1: Preoperative antibiotic prophylaxis in patients with PJI does not interfere with the isolation of the microorganism from the intraoperative cultures and sonication samples.
Goals:
Main Goal:
- Determine preoperative antibiotic prophylaxis outcome on cultures obtained intraoperatively.
Secondary Goals:
- Ascertain if organisms isolated from preoperative joint aspirate correspond to those isolated from intraoperative cultures;
- Verify if the addition of substances with chelation properties to hemoculture containers filled with sonication samples affects antibiotic prophylaxis outcome;
- Make a descriptive analysis and revision of microorganisms implicated in PJIs.
PATIENTS AND METHODS:
Prospective, Randomized, Double-blind Clinical trial (Level I of Evidence):
Group I (study group): antibiotic prophylaxis + empiric antibiotic treatment once obtained intraoperative culture results.
Group II (control group): Empiric antibiotic treatment once obtained intraoperative culture results.
At the present institution, the investigators routinely administer intravenous prophylactic antibiotic, such as first-generation cephalosporins (2g cefazolin), or Glycopeptide derivatives (1g Vancomycin) if penicillin allergies are reported. This antibiotic administration schedule is initiated 30-60 minutes, or 60 minutes before surgery, respectively.
Empiric antibiotic treatment (vancomycin 1g/12h + ceftazidim 2g/8h) will be administered if aspiration cultures results are negative, or the infecting microorganism is unknown. Contrariwise, if the infecting microorganism is isolated and its antibiogram known, targeted antibiotic therapy will be used accordingly.
Patients were assigned to each group using a computer generated random selection scheme from Statistic Assessment Department. Both doctors and patients have been blinded for this information to ensure there are no differences in the way information is assessed or managed, in order to minimize bias. The study and placebo solutions will be prepared by the nurse on duty according to the anesthesiologist recommendations.
The surgical techniques performed vary according to the type of infection. In chronic infections the investigators will proceed to remove the infected prosthesis and implant the cement spacer, whereas in acute infections the adopted technique will be irrigation and débridment with liner exchange and retention of components. Once obtained intraoperative cultures and sonication samples, antibiotic prophylaxis regimen will be initiated with vancomycin (1g/12h) and ceftazidim (2g/8h), both for acute and chronic infections. In case there is a positive synovial fluid aspiration result, the investigators will perform targeted antibiotic treatment according to antibiogram. Hence, patients assigned to the control group will be able to receive an adequate antibiotic coverage. Additionally, there are no guidelines or clinical recommendations about the use of antibiotic prophylaxis in first-stage exchange, or irrigation and débridment procedures.
The protocol and surgical techniques performed, as well as the prosthetic models and cement spacers are the same the investigators use in the Department of Orthopaedic surgery and Traumatology of the study center, which have already been approved by a proper board review. That said, his clinical trial will not suppose any modification to the current clinical practice, neither to the microbiological techniques and methods applied.
Data collection:
- Preoperative data: gender, age, weight, Body Mass Index, comorbidities, type of prosthesis, mean time to diagnosis, preoperative joint aspirate microbiologic analysis and blood cell count.
- Intraoperative data: Whether or not antibiotic has been used and type of antibiotic used.
- Postoperative data: Intraoperative culture results and microbiological technique employed.
The investigators will consider false-negatives those patients who do not meet the infection criteria referred above (see inclusion criteria) and those who present negative culture results.
The routine surgical follow-up is scheduled 4, 6, 12 and 24 weeks after surgical intervention, as recommended by the study hospital protocol.
STATISTICS:
Statistical analysis:
Firstly, the investigators will perform a descriptive analysis of the study population. Whereas categorical variables will be expressed as numbers and frequencies, parameters measured on a continuous scale will be represented by their mean and standard deviation, in case they follow a normal distribution. Otherwise, the investigators will employ quartiles and median values to describe them.
Secondly, a bivariate analysis comparing each parameter with the group patients were assigned to will be executed, using the Chi Square or Fisher test to describe categorical variables. As to qualitative parameters, a variance analysis will be done if the variables follow a normal distribution. Otherwise, Kruskal-Wallis and Man-Whitney test will be used.
Finally, the investigators will employ a relative risk method to evaluate negativization risk.
The investigators will consider statistically significant p values under 0.05 and use SPSS 18.0 (SPSS inc, Chicago- Illinois) software and Prism (6.01 version, Graphpad, La Jolla, CA) for graphical analyses.
Sample Size:
The investigators undertook a Chi Square difference test to determine the sample size, assuming a 15% false negative rate in the control group, a 60% false negative rate in the study group and a 10% rate of lost to follow-up. The test revealed that 14 patients were needed in each group to detect statistically significant differences, establishing an α error of 0.05 and a statistical power of 80%.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Cefazolin, Control group
- Keywords
- antibiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Also called vancomycin
Cefazolin (vancomycin in the case of allergy to cefazolin)
Control groupOther
no antibiotic prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | no antibiotic prophylaxis group Receives: Other: Control group |
| Study group cefazolin | Active comparator | Classical antibiotic prophylaxis Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Cultures
Number of positive Tissue Cultures (7)
Measured: 14 days
Sonication Cultures
Number of positive Sonication cultures (7)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Pérez Prieto, Parc de Salut Mar
- Investigators
- Daniel Pérez-Prieto, MD, Study director, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413034
- Sponsor's protocol ID
- 2014/5533/I
- Status last verified
- Jun 2016
- First submitted
- 24 Mar 2015
- Last updated
- 3 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
PubMed 15483283Trampuz A, Piper KE, Jacobson MJ, Hanssen AD, Unni KK, Osmon DR, Mandrekar JN, Cockerill FR, Steckelberg JM, Greenleaf JF, Patel R. Sonication of removed hip and knee prostheses for diagnosis of infection. N Engl J Med. 2007 Aug 16;357(7):654-63. doi: 10.1056/NEJMoa061588.
PubMed 17699815Burnett RS, Aggarwal A, Givens SA, McClure JT, Morgan PM, Barrack RL. Prophylactic antibiotics do not affect cultures in the treatment of an infected TKA: a prospective trial. Clin Orthop Relat Res. 2010 Jan;468(1):127-34. doi: 10.1007/s11999-009-1014-4. Epub 2009 Aug 11.
PubMed 19669849Portillo ME, Salvado M, Alier A, Sorli L, Martinez S, Horcajada JP, Puig L. Prosthesis failure within 2 years of implantation is highly predictive of infection. Clin Orthop Relat Res. 2013 Nov;471(11):3672-8. doi: 10.1007/s11999-013-3200-7. Epub 2013 Aug 1.
PubMed 23904245
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures
- ClinicalTrials.gov ID
- NCT02413034
- Acronym / sponsor ID
- 2014/5533/I
- Conditions
- Prosthetic Joint Infection
- Keywords
- antibiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 3 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total joint replacement is a common clinical practice for patients suffering from disabling arthritis, since it provides significant pain relief and functional recovering. Nevertheless, its outcome is compromised by complications such as periprosthetic joint infection (PJI), which is reported to occur in 1 to 4% of primary total knee arthroplasties (TKA), and approximately 1% of primary total hip replacements (THR). Despite all efforts to restrain PJI, its prevalence may reach even higher proportions if patients undergo a resection arthroplasty or irrigation and débridement for infected prosthesis. That said, timely diagnosis and early isolation of the infected microorganism is utterly important, if proper care is to be delivered.
The gold standard for the diagnosis of PJI is the isolation of a microorganism from the intraoperative cultures, combined with the sonication from retrieved joint implants1. This technique applies sound energy to agitate and disrupt biofilm, dislodging adherent bacterias to the bone cement, which has been proved to be a more sensitive method than conventional intraoperative cultures. False-negative percentages were reported to be 15% in patients who did not receive extended antibiotic prophylaxis and 60% if extended antibiotic therapy was administered.
Regardless of an adequate clinical, radiographic and surgical suspicion confirming PJI, an organism is not always successfully isolated from the intraoperative cultures, which increases false negatives results. This fact has been trying to be explained by several authors, some of which postulate that antibiotic prophylaxis could interfere with the isolation of the microorganism from the intraoperative cultures. As a result, and acting accordingly to this hypothesis, preoperative antibiotics are often withheld until intraoperative cultures are obtained, hoping that tissues are not loaded with antibiotics. Nevertheless, one should be aware of the adverse consequences of this practice that may result in systemic dissemination of infection.
Moreover, Ghanem and Stephen recently concluded that antibiotic prophylaxis does not interfere with the isolation of the microorganism from intraoperative cultures, despite being studies that lack statistical power.
Therefore, it is clear that reported studies in this field support both preoperative antibiotic prophylaxis administration, as well its withdrawal, until intraoperative cultures are obtained.
This decision in the department study depends exclusively on the treating surgeon judgment. In fact, 48% of all patients admitted at the study hospital with PJI receive preoperative antibiotic prophylaxis, which could be related to higher false-negative intraoperative culture and sonication results. Thus, the investigators add substances with chelation properties to hemoculture containers and then inoculate sonication samples. This practice offsets antibiotic interference with intraoperative cultures and has proved to enhance microorganism detection rates.
That said, and given the lack of scientific evidence about this clinical practice the investigators are willing to engage a prospective randomized double-blind clinical trial, that will allow us to determine whether intraoperative cultures and sonication samples are affected by antibiotic prophylaxis.
Detailed description
AIM AND RATIONALE:
Hypothesis:
H0: Preoperative antibiotic prophylaxis in patients with PJI interferes with the isolation of the microorganism from the intraoperative cultures and sonication samples, resulting in higher false-negative results.
H1: Preoperative antibiotic prophylaxis in patients with PJI does not interfere with the isolation of the microorganism from the intraoperative cultures and sonication samples.
Goals:
Main Goal:
- Determine preoperative antibiotic prophylaxis outcome on cultures obtained intraoperatively.
Secondary Goals:
- Ascertain if organisms isolated from preoperative joint aspirate correspond to those isolated from intraoperative cultures;
- Verify if the addition of substances with chelation properties to hemoculture containers filled with sonication samples affects antibiotic prophylaxis outcome;
- Make a descriptive analysis and revision of microorganisms implicated in PJIs.
PATIENTS AND METHODS:
Prospective, Randomized, Double-blind Clinical trial (Level I of Evidence):
Group I (study group): antibiotic prophylaxis + empiric antibiotic treatment once obtained intraoperative culture results.
Group II (control group): Empiric antibiotic treatment once obtained intraoperative culture results.
At the present institution, the investigators routinely administer intravenous prophylactic antibiotic, such as first-generation cephalosporins (2g cefazolin), or Glycopeptide derivatives (1g Vancomycin) if penicillin allergies are reported. This antibiotic administration schedule is initiated 30-60 minutes, or 60 minutes before surgery, respectively.
Empiric antibiotic treatment (vancomycin 1g/12h + ceftazidim 2g/8h) will be administered if aspiration cultures results are negative, or the infecting microorganism is unknown. Contrariwise, if the infecting microorganism is isolated and its antibiogram known, targeted antibiotic therapy will be used accordingly.
Patients were assigned to each group using a computer generated random selection scheme from Statistic Assessment Department. Both doctors and patients have been blinded for this information to ensure there are no differences in the way information is assessed or managed, in order to minimize bias. The study and placebo solutions will be prepared by the nurse on duty according to the anesthesiologist recommendations.
The surgical techniques performed vary according to the type of infection. In chronic infections the investigators will proceed to remove the infected prosthesis and implant the cement spacer, whereas in acute infections the adopted technique will be irrigation and débridment with liner exchange and retention of components. Once obtained intraoperative cultures and sonication samples, antibiotic prophylaxis regimen will be initiated with vancomycin (1g/12h) and ceftazidim (2g/8h), both for acute and chronic infections. In case there is a positive synovial fluid aspiration result, the investigators will perform targeted antibiotic treatment according to antibiogram. Hence, patients assigned to the control group will be able to receive an adequate antibiotic coverage. Additionally, there are no guidelines or clinical recommendations about the use of antibiotic prophylaxis in first-stage exchange, or irrigation and débridment procedures.
The protocol and surgical techniques performed, as well as the prosthetic models and cement spacers are the same the investigators use in the Department of Orthopaedic surgery and Traumatology of the study center, which have already been approved by a proper board review. That said, his clinical trial will not suppose any modification to the current clinical practice, neither to the microbiological techniques and methods applied.
Data collection:
- Preoperative data: gender, age, weight, Body Mass Index, comorbidities, type of prosthesis, mean time to diagnosis, preoperative joint aspirate microbiologic analysis and blood cell count.
- Intraoperative data: Whether or not antibiotic has been used and type of antibiotic used.
- Postoperative data: Intraoperative culture results and microbiological technique employed.
The investigators will consider false-negatives those patients who do not meet the infection criteria referred above (see inclusion criteria) and those who present negative culture results.
The routine surgical follow-up is scheduled 4, 6, 12 and 24 weeks after surgical intervention, as recommended by the study hospital protocol.
STATISTICS:
Statistical analysis:
Firstly, the investigators will perform a descriptive analysis of the study population. Whereas categorical variables will be expressed as numbers and frequencies, parameters measured on a continuous scale will be represented by their mean and standard deviation, in case they follow a normal distribution. Otherwise, the investigators will employ quartiles and median values to describe them.
Secondly, a bivariate analysis comparing each parameter with the group patients were assigned to will be executed, using the Chi Square or Fisher test to describe categorical variables. As to qualitative parameters, a variance analysis will be done if the variables follow a normal distribution. Otherwise, Kruskal-Wallis and Man-Whitney test will be used.
Finally, the investigators will employ a relative risk method to evaluate negativization risk.
The investigators will consider statistically significant p values under 0.05 and use SPSS 18.0 (SPSS inc, Chicago- Illinois) software and Prism (6.01 version, Graphpad, La Jolla, CA) for graphical analyses.
Sample Size:
The investigators undertook a Chi Square difference test to determine the sample size, assuming a 15% false negative rate in the control group, a 60% false negative rate in the study group and a 10% rate of lost to follow-up. The test revealed that 14 patients were needed in each group to detect statistically significant differences, establishing an α error of 0.05 and a statistical power of 80%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Control groupno antibiotic prophylaxis group |
| Study group cefazolin | Active comparator | Drug: CefazolinClassical antibiotic prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All the patients diagnosed with PJI who meet Zimmerli criteria and undergo a first-stage exchange, or débridment and retention procedure, in case there is an acute infection. These criteria are: visible sinus tract or purulence surrounding the prosthesis; detection of an infecting microorganism in the synovial fluid aspiration samples, intraoperative tissue and/or fluid cultures; synovial white blood cell count and histopathology parameters. The investigators will also include an additional criterion, which is prosthetic loosening 2 years after primary arthroplasty implantation following recent Portillo findings.
- The investigators will include hip, knee and shoulder replacements.
Key exclusion criteria (2 listed)
- Patients receiving any kind of antibiotic regimen during the previous week of surgery;
- Hemodynamically unstable patients in need of antibiotic therapy, previously to the surgery.
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 |
|---|---|---|
| CefazolinAlso: vancomycinCefazolin (vancomycin in the case of allergy to cefazolin) | Drug | Study group cefazolin |
| Control groupno antibiotic prophylaxis | Other | Control group |
Primary outcome
Positive Cultures
Time frame: 14 days
Number of positive Tissue Cultures (7)
Sonication Cultures
Time frame: 14 days
Number of positive Sonication cultures (7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15483283Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
- Background: PubMed 17699815Trampuz A, Piper KE, Jacobson MJ, Hanssen AD, Unni KK, Osmon DR, Mandrekar JN, Cockerill FR, Steckelberg JM, Greenleaf JF, Patel R. Sonication of removed hip and knee prostheses for diagnosis of infection. N Engl J Med. 2007 Aug 16;357(7):654-63. doi: 10.1056/NEJMoa061588.
- Background: PubMed 19669849Burnett RS, Aggarwal A, Givens SA, McClure JT, Morgan PM, Barrack RL. Prophylactic antibiotics do not affect cultures in the treatment of an infected TKA: a prospective trial. Clin Orthop Relat Res. 2010 Jan;468(1):127-34. doi: 10.1007/s11999-009-1014-4. Epub 2009 Aug 11.
- Background: PubMed 23904245Portillo ME, Salvado M, Alier A, Sorli L, Martinez S, Horcajada JP, Puig L. Prosthesis failure within 2 years of implantation is highly predictive of infection. Clin Orthop Relat Res. 2013 Nov;471(11):3672-8. doi: 10.1007/s11999-013-3200-7. Epub 2013 Aug 1.
- 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.
Daniel Pérez-Prieto, MD study director
Hospital del Mar
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin in people with Prosthetic Joint Infection, run by Parc de Salut Mar.
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 2 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: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Positive Cultures (time frame: 14 days). 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 NCT02413034, which also lists 4 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 3 Aug 2016.