The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study.

BACKGROUND: There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies). During the COVID-19 pandemic, the need for hospital admission and mortality is higher in people > 60 years. Therefore, this is a target population to try to reduce the serious complications and lethality of COVID pneumonia and to avoid overloading the hospital system. Given the pharmacological properties of colchicine (anti-inflammatory and anti-fibrotic, possible inhibition of viral replication, and inhibitory effect on coagulation activation), early treatment with colchicine may reduce the rate of death and serious pulmonary complications from COVID-19 in vulnerable patients. METHODS: The COLCHICOVID study is a randomized, multicenter, controlled, open-label parallel group (2:1 ratio), phase III clinical trial to investigate the efficacy of early administration of colchicine in reducing the development of severe pulmonary complications associated with COVID-19 infection in patients over 60 years of age with at-risk comorbidities. DISCUSSION: This is a pragmatic clinical trial, adapted to usual clinical practice. The demonstration that early administration of colchicine has clinical effectiveness in reducing the complications of SARS-CoV-2 infection in a population highly susceptible may mitigate the health crisis and prevent the collapse of the health system in the successive waves of the coronavirus pandemic. In addition, colchicine is a well-known medicine, simple to use in the primary care setting and with a low cost for the health system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04416334 . Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020.

The efficacy of suppressive antibiotic treatment in patients managed non-operatively for periprosthetic joint infection and a draining sinus.

Objectives: Patients with prosthetic joint infections (PJIs) not suitable for curative surgery may benefit from suppressive antibiotic therapy (SAT). However, the usefulness of SAT in cases with a draining sinus has never been investigated. Methods: A multicentre, retrospective observational cohort study was performed in which patients with a PJI and a sinus tract were eligible for inclusion if managed conservatively and if sufficient follow-up data were available (i.e. at least 2 years). SAT was defined as a period of >  6 months of oral antibiotic therapy. Results: SAT was initiated in 63 of 72 (87.5 %) included patients. Implant retention during follow-up was the same in patients receiving SAT vs. no SAT (79.4 % vs. 88.9 %; p = 0 .68). In total, 27 % of patients using SAT experienced side effects. In addition, the occurrence of prosthetic loosening in initially fixed implants, the need for surgical debridement, or the occurrence of bacteremia during follow-up could not be fully prevented with the use of SAT, which still occurred in 42 %, 6.3 %, and 3.2 % of cases, respectively. However, the sinus tract tended to close more often (42 % vs. 13 %; p = 0 .14), and a higher resolution of pain was observed (35 % vs. 14 %; p = 0 .22) in patients receiving SAT. Conclusions: SAT is not able to fully prevent complications in patients with a draining sinus. However, it may be beneficial in a subset of patients, particularly in those with pain or the hindrance of a draining sinus. A future prospective study, including a higher number of patients not receiving SAT, is needed.

Candida periprosthetic joint infection: A rare and difficult-to-treat infection.

BACKGROUND: Candida periprosthetic joint infection (CPJI) is a rare, difficult-to-treat disease. The purpose of this study was to evaluate the clinical characteristics and outcomes of CPJI treated with various surgical and antifungal strategies. METHODS: We conducted a multicenter retrospective study of all CPJI diagnosed between 2003 and 2015 in 16 Spanish hospitals. RESULTS: Forty-three patients included: median age, 75 years, and median Charlson Comorbidity Index score, 4. Thirty-four (79.1%) patients had ≥1 risk factor for Candida infection. Most common causative species were C. albicans and C. parapsilosis. Thirty-five patients were evaluable for outcome: overall, treatment succeeded in 17 (48.6%) and failed in 18 (51.4%). Success was 13/20 (67%) in patients with prosthesis removal and 4/15 (27%) with debridement and prosthesis retention (p = 0.041). All 3 patients who received an amphotericin B-impregnated cement spacer cured. In the prosthesis removal group, success was 5/6 (83%) with an antibiofilm regimen and 8/13 (62%) with azoles (p = 0.605). In the debridement and prosthesis retention group, success was 3/10 (30%) with azoles and 1/5 (20%) with antibiofilm agents. Therapeutic failure was due to relapse in 9 patients, need for suppressive treatment in 5, persistent infection in 2, and CPJI-related death in 2; overall attributable mortality was 6%. CONCLUSIONS: CPJI is usually a chronic disease in patients with comorbidities and risk factors for Candida infection. Treatment success is low, and prosthesis removal improves outcome. Although there is insufficient evidence that use of antifungals with antibiofilm activity has additional benefits, our experience indicates it may be recommendable.

A biofilm approach to detect bacteria on removed spinal implants.

STUDY DESIGN: This is a prospective study comparing the diagnosis of spinal implant infection by conventional peri-implant tissue culture with a technique which uses a combination of vortexing and bath sonication to dislodge bacteria growing as a biofilm on the surface of retrieved spinal implants. OBJECTIVE: We hypothesized that the biofilm-sampling technique would be more sensitive than peri-implant tissue culture. SUMMARY OF BACKGROUND DATA: Culture of peri-implant tissue is inaccurate for the diagnosis of orthopedic device-related infection; cultures taken from the implant may be more sensitive. We have developed a technique which uses vortexing-bath sonication to sample bacterial biofilms on the surface of retrieved hip and knee implants, and shown that it is more sensitive than peri-prosthetic tissue culture for the microbiologic diagnosis of prosthetic knee, hip, and shoulder infection. METHODS: We compared peri-implant tissue culture to the vortexing-bath sonication technique which samples bacterial biofilm on the surface of retrieved spinal implants, for the diagnosis of spinal implant infection. In addition, we compared detection of Staphylococcus and Propionibacterium acnes by rapid cycle real-time polymerase chain reaction with culture of sonicate fluid. RESULTS: A total of 112 subjects were studied; 22 had spinal implant infection. The sensitivities of peri-implant tissue and sonicate fluid culture were 73% and 91% (P = 0.046), and the specificities were 93% and 97%, respectively. P. acnes and coagulase-negative staphylococci were the most frequent microorganisms detected among subjects with spinal implant infection, with P. acnes detected in 56 and 45%, and coagulase-negative staphylococci detected in 31 and 40% of peri-implant tissue and sonicate fluid cultures, respectively. Compared with the culture of sonicate fluid, polymerase chain reaction was 100 and 67% sensitive for the detection of culture-positive Staphylococcus and P. acnes spinal implant infection, respectively. CONCLUSION: Implant sonication followed by culture is more sensitive than peri-implant tissue culture for the microbiologic diagnosis of spinal implant infection.

Species of Propionibacterium and Propionibacterium acnes phylotypes associated with orthopedic implants.

Propionibacterium sp. is commonly isolated in association with orthopedic implants, either as a pathogen or a colonizer. Microbial characteristics that indicate whether the isolated species is a likely cause of orthopedic implant infection versus a colonizing agent would be clinically useful. We performed a prospective trial to determine the species of Propionibacterium and the phylotype (IA, IB, II, III) of Propionibacterium acnes isolated from the surface of removed orthopedic implants, and we correlated these findings with the presence or absence of infection. P. acnes represented 61 of 62 isolates. P. acnes type I was more commonly isolated than was type II (62% versus 38%, respectively), whether associated with infection or not. P. acnes type III was not detected. There was no clear association between types I and II P. acnes and infection or colonization of failed orthopedic implants (P = 0.75), however type IB strains were more frequently isolated than type IA from infected prosthese.

Effect of electrical current on the activities of antimicrobial agents against Pseudomonas aeruginosa, Staphylococcus aureus, and Staphylococcus epidermidis biofilms.

Bacterial biofilms are resistant to conventional antimicrobial agents. Prior in vitro studies have shown that electrical current (EC) enhances the activities of aminoglycosides, quinolones, and oxytetracycline against Pseudomonas aeruginosa, Klebsiella pneumoniae, Staphylococcus epidermidis, Escherichia coli, and Streptococcus gordonii. This phenomenon, known as the bioelectric effect, has been only partially defined. The purpose of this work was to study the in vitro bioelectric effect on the activities of 11 antimicrobial agents representing a variety of different classes against P. aeruginosa, methicillin-resistant Staphylococcus aureus (MRSA), and S. epidermidis. An eight-channel current generator/controller and eight chambers delivering a continuous flow of fresh medium with or without antimicrobial agents and/or EC to biofilm-coated coupons were used. No significant decreases in the numbers of log(10) CFU/cm(2) were seen after exposure to antimicrobial agents alone, with the exception of a 4.57-log-unit reduction for S. epidermidis and trimethoprim-sulfamethoxazole. We detected a statistically significant bioelectric effect when vancomycin plus 2,000 microamperes EC were used against MRSA biofilms (P = 0.04) and when daptomycin and erythromycin were used in combination with 200 or 2,000 microamperes EC against S. epidermidis biofilms (P = 0.02 and 0.0004, respectively). The results of these experiments indicate that the enhancement of the activity of antimicrobial agents against biofilm organisms by EC is not a generalizable phenomenon across microorganisms and antimicrobial agents.

Infections associated with long-term prosthetic devices.

The extensive and ever-increasing use of long-term prosthetic devices has improved quality of life and survival for many patients. Prosthetic device-related infection occurs infrequently but is associated with significant morbidity and mortality. Management is challenging, often requiring prolonged antimicrobial therapy and surgical intervention. Better understanding of the interaction between microorganisms, devices, and the host should improve the ability to manage device-related infections. This article reviews recent advances in the diagnosis and treatment of infections associated with indwelling medical devices, highlighting those associated with prosthetic joints, cerebrospinal fluid shunts, and prosthetic heart valves.