Infections

All Conditions

Neoplasms

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Communicable Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer

No use of antimicrobial prophylaxis

Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer

Use of antimicrobial prophylaxis

Oh Jeong, M.D.,Ph.D.

Laparoscopic gastrectomy has fewer infectious complications compared to open surgery. Recently, the incidence of postoperative infectious complications was greatly reduced due to the development of surgical techniques and improvement of prevention and control of surgical infection. Previous multicenter, phase II study (KSWEET-01) revealed that the incidence of infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not significantly higher than previously reported data.

Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy without prophylactic antibiotics, specially reference to the postoperative infectious complications.

The purpose of this study was to investigate the non-inferiority of incidence of infectious complications in the experimental group that did not use prophylactic antibiotics compared to the control group using prophylactic antibiotics.

The primary endpoint is the incidence of surgical site infections within 30 days after surgery and the difference limit of the non-inferiority of the experimental group is assumed to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in the control group is 5% and the incidence of infectious complications in the experimental group is assumed to be about 8%. It is assumed that the significant level is 5% and the power is at least 80%.

According to the above method, a total of 260 patients (130 patients in each group) are needed when 117 patients are needed in each group and about 10% of drop rates and protocol violence are considered.

Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy

Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)

The diagnosis of infectious complications is made according to the Centers for Disease Control and Prevention (CDC) surgical site infection diagnosis criteria according to physical or radiological findings.

From date of operation until the date of hospital discharge

Any postoperative infectious complications other than surgical site infections

Korean South West East Gastric Surgery Group

MD, PhD, FACS

Blood and Lymph Conditions

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion

Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion

Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops

Prophylactic White Cell Transfusion

Radiated white blood cell transfusions daily only with infection (or persistent fever)

Therapeutic White Cell Transfusion

Emil J Freireich, MD, BS

Patients with leukemia often have low white blood cell counts after chemotherapy, which puts them at greater risk for infection. The standard of care for preventing infections is to give these patients antibiotic, antifungal, and antiviral drugs during the time that white blood cell counts are low. However, many patients still develop infections during chemotherapy. Radiated white blood cell transfusions are a standard treatment once a patient develops a severe infection.

The goal of this clinical research study is to learn if giving unirradiated white blood cell transfusions early in chemotherapy might delay or prevent infections in patients with leukemia. Researchers also want to learn more about the type and severity of any infections that do occur.

Study Groups:

If you are found to be eligible to take part of this study, and you are 1 of the first 60 participants to be enrolled, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:

* If you are in Group 1, you will receive the standard of care drugs that are used to prevent infections. You will also receive unirradiated white blood cell transfusions 2-3 times each week. If at any point you develop an infection, white blood cell transfusions will then be given daily in addition to the standard treatment for the infection.
* If you are in Group 2, you will receive the standard of care drugs that are used to prevent infections. You will only receive unirradiated white blood cell transfusions if at any point you develop an infection. You will receive these transfusions daily, in addition to the standard treatment for the infection.

If you are not 1 of the first 60 participants to be enrolled, you will be assigned to the study group that the study doctor decides is in your best interest. This will be decided based on how the first participants have responded to the different treatments.

The drugs you receive as part of the standard therapy will be up the study doctor.

Study Procedures:

During each white blood cell transfusion, you will receive white blood cells from a volunteer donor through a needle in your vein. Each transfusion will take anywhere from 1 hour to several hours, depending on how you tolerate the treatment.

Before each white blood cell transfusion, your vital signs will be recorded. During and for 1 hour after the transfusion, you will be monitored for side effects. You may be given a drug to help or reduce any side effects. Your doctor will tell you more about any drug that is given for side effects.

While you are in the hospital for leukemia treatment, blood (about 1 teaspoon) will be drawn to check for fungal infections 2-3 times each week. This test will be done 1 time each week when you are not in the hospital until the doctor no longer thinks it is needed.

If at any point you develop a fever while on study, blood (about 1 teaspoon) will be drawn to check for infection. You will also have a CT scan within 3 days of developing a fever. If the doctor thinks it is needed, you will then have a CT scan 2 weeks later and at any other point that the doctor thinks it is needed to check for infection.

Length of Study:

You will continue to have transfusions until the doctor thinks infection has been controlled or until your white blood cell counts stay at a certain level for at least 2 days in a row. If at any point you are discharged from the hospital and your doctor wants you to continue receiving white blood cell transfusions, you will be able to receive them as an outpatient.

You will be monitored for side effects and signs of infection for up to 2 cycles of anti-leukemia treatment through a review of your medical record. You will be taken off study if you have intolerable side effects.

This is an investigational study. Radiated white blood cell transfusions are considered to be a standard procedure for the treatment of serious infections. It is investigational to give unirradiated white blood cell transfusions as a way of preventing infections.

Up to 240 patients will take part in this study. All will be enrolled at MD Anderson.

Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia

A Prospective Randomized Comparative Study of the Effect on Infections of Radiated Prophylactic White Cell Transfusions Versus Therapeutic Radiated White Cell Transfusions

Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.

M.D. Anderson Cancer Center

Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops

Arm 1 (Prophylactic Arm)

Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)

Arm 2 (Therapeutic Arm)

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Emil Freireich, MD, Professor, Department of Medical Education

Outcomes inevaluable due to low recruitment.

Number of Participants With Infection

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Ciprofloxacin

Cefazolin

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Patients in this arm will receive Ciprofloxacin 400mg IV 120mn (prophylactic antibiotic) before their HDR brachytherapy

Patients in this arm will receive Cefazolin 2000mg IV 60mn (prophylactic antibiotic) before their HDR brachytherapy

Patients in this arm will not receive any prophylactic antibiotics before their HDR brachytherapy

Ciprofloxacin 400 mg IV 120mn before HDR brachytherapy

Marjory Jolicoeur, MD,MSc

Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.

INTRODUCTION:

High dose rate (HDR) brachytherapy boost with external beam is the current recommended treatment for intermediate and high risk prostate cancers (1, 2). HDR brachytherapy uses transperineal implant (at least 15 prostate catheters) to deliver the calculated dose though a robot that contains the radioactive source. Once treatment is completed, the implant is retrieved and a dressing with an antibiotic ointment is placed on the perineum for a few hours.

The procedure is performed under spinal anesthesia, transperineally following a sterile wash. The implantation is guided from the transrectal ultrasound (TRUS). The procedure contains a series of back and forth probe movements that raises the contamination risk of the implantation zone which is considered non-negligible. Brachytherapy patients undergo urinanalysis before the implantation and redo the test at the least urinary symptom.

The suspicion of a contamination risk of the urinary tract during the procedure has therefore led to antibiotic prophylaxis habit. This habit has been based on experts' opinion mainly motivated by the antibiotic prophylaxis use for TRUS guided biopsies of the prostate.

Literature on antibiotic prophylaxis use for prostate brachytherapy is limited, both on the use of intraoperative or post-procedure antibiotic prophylaxis and on the risk of infectious complications following the brachytherapy procedure.

The use of antibiotic prophylaxis for prostate brachytherapy is derived from urology studies based on prostate biopsies (3, 4). Nevertheless, biopsy procedure is completely different from the implantation used on brachytherapy. Moreover, biopsies are done transrectally with bacterial dissemination risk on blood circulation, while brachytherapy is done transperineally.

Current recommendations from American Brachytherapy Society (ABS) do not state on the use of antibiotic prophylaxis for brachytherapy prostate patients (5). Antibiotic prophylaxis is however cited as possibly useful. The European Society for Radiation and Oncology (GEC-ESTRO) does not comment on the need for antibiotic prophylaxis, but mentions cystitis as a possible complication for prostate brachytherapy (1, 2). It is important to consider that these recommendations are based on expert opinion (level of evidence V). Unfortunately, there is no randomized trial (level of evidence I) to guide the use of antibiotic prophylaxis for prostate brachytherapy.

The most current used molecule for the antibiotic prophylaxis of the urinary tract is Ciprofloxacin. Yet, Ciprofloxacin is linked to the upsurge of C. difficile and the use of this molecule is linked to the appearance of many bacterial strains resistant to antibiotics (6). Other antibiotics, like Cefazolin do not have the same association with C. difficile and other multidrug-resistant bacteria. Cefazolin is equally used as antibiotic prophylaxis for pelvic surgery. Investigators can suppose that Ciprofloxacin can be replaced by Cefazolin as an antibiotic prophylaxis for prostate brachytherapy, causing less harm.

Moreover, one study compared both antibiotics (Ciprofloxacin and Cefazolin) in the prophylactic use in 100 patients (7). Authors demonstrated equivalence between both drugs for the prevention of urinary contamination. Although the study was not designed to demonstrate equivalence and the observed effect may be due to low number of randomized patients.

Furthermore, this study has not demonstrated beyond any doubt the need of antibiotic prophylaxis for prostate brachytherapy. Investigators continue to be uncertain about the need of antibiotic prophylaxis, as the rate of urinary infections without antibiotic prophylaxis after prostate brachytherapy continues to be unknown.

Nevertheless, radiation side effects on the urinary function are well known and are systematically reviewed by validate questionnaires, such as International Prostate Symptom Score (IPSS) and are graded accordingly to the Common Terminology Criteria for Adverse Events (CTCAE) score.

In summary, there is no evidence in the literature of the need for antibiotic prophylaxis in prostate brachytherapy. Likewise, there is no evidence to support that if used, it should be Ciprofloxacin. Furthermore, in times of multidrug-resistant bacteria, it is important to decrease the use of these molecules. This is why the investigators propose a phase III randomized clinical trial to evaluate the risk of urinary tract infection in the presence or absence of antibiotic prophylaxis for prostate brachytherapy.

METHODS:

Hypothesis:

The investigators hypothesize that the risk of infectious complication of the urinary tract following prostate brachytherapy is the same with or without antibiotic prophylaxis.

Objectives:

Primary:

- Evaluate the rate of urinary tract infections following prostate brachytherapy.

Secondary:

* Evaluate the rate and grade of the urinary tract complications in the presence and absence of antibiotics.
* Evaluate the effect on the IPSS score in the presence and absence of antibiotics.
* Evaluate the rate of serious infectious complications related to brachytherapy.
* Evaluate the risk of colitis due to C. difficile in the 12 weeks following the brachytherapy

Patient selection:

Inclusion and exclusion criteria are described elsewhere.

Pre-implant evaluation (morning of the intervention):

* Urinary test and culture
* Bladder scan

Treatment:

The patients are treated by HDR brachytherapy boost with external beam according to the current standards. Current standard also premise that patients are followed up weekly by their doctor. During patient visits, urinary symptoms questionnaire is fulfilled and urinary tests are performed as needed.

In the study establishment, patient is seen the next day of the procedure to retrieve the urinary catheter left after the procedure. During this visit a bladder scan post-miction is performed to check the bladder residual volume.

Antibiotic prophylaxis:

Randomization in 3 arms: Ciprofloxacin 400 mg IV 120 mn pre-operative, Cefazolin 2g IV 60 mn pre-operative or no antibiotic prophylaxis.

Data gathering:

Patient is to be seen day of the procedure (day 0), the next day (day 1), 3 days after the procedure (day 3), one week after (day 7), 1 month (day 30) and 3 months after procedure (day 90). Patients will fulfill IPSS questionnaire, make urine tests and a bladder scan in every visit.

Patients will be seen weekly during the external beam treatment by their doctor. Patient's symptoms will be graded according to the RTOG score. In cases with suspicion of urinary tract infection or prostatitis during the treatments, the standard procedure with urinary tests will take place.

Statistical Analysis:

The basic assumption is the probability of no difference in bacteriuria and change in the IPSS score between the 3 arms.

Sample size:

A difference of 15% between the groups equates to an effect size of 0.24 which is the magnitude of Chi-square that needs to be detected, gives us a power of 83%. Calculation was done using the PASS software.

A total of 234 eligible patients (78 per arm) are required for a power of 92% and a risk of the first species of 0.05. Adjust for 10% of ineligibility, the number needed is 255 patients (85 per arm).

Data analysis :

Data reading and statistical analysis will be done by the Statistical Analysis Software (SAS) package.

Socio-demographic characteristics, IPSS scores and patient's clinical data will be described by descriptive statistics (means, standard deviation, proportions, etc.). Anova or Chi-square tests will be used to compare arms. Multivariate logistic regression models will allow us to determine the potential associations between our categorical dependent variables while controlling for both sociodemographic factors and especially for potentially confounding clinical variables.

Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer

Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer: a Phase III Randomized Trial

The rate of symptomatic urinary infections post HDR brachytherapy.

Urinary toxicities rate in each arm measured by the Common Terminology Criteria for Adverse Events (CTCAE) score. The following Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOC) will be included: Renal and urinary disorders, and Infections and infestations. The CTCAE score ranges from grade 0 to 5, where higher grade represents higher toxicity. Each presented toxicity will be assessed and scored. Each toxicity will be evaluated by its percentage of incidence in the sample. Each patient will also be evaluated by his worse toxicity (higher grade). The percentage of toxicities incidence and their severity will be compared between groups.

Evaluate International Prostate Symptom Score (IPSS) effects of prophylactic antibiotics. The IPSS Score ranges from 0 to 35. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. Mean scores will be compared between groups.

Evaluate the rate of serious infectious complications post HDR brachytherapy

To evaluate the risk of colitis due to C. difficile infection all patients with diarrhea or increased bowel movement (colitis symptoms) will be tested for C. difficile infection. The association between colitis and the presence of C. difficile infection will be evaluated by Chi-square in each group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy	NCT03802097	Gastric Cancer Complication of...	No use of antim... Use of antimicr...	18 Years - 75 Years	Korean South West East Gastric Surgery Group
Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia	NCT01204788	Leukemia	Prophylactic Wh... Therapeutic Whi...	2 Years -	M.D. Anderson Cancer Center
Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer	NCT03862170	Prostate Cancer	Ciprofloxacin Cefazolin	18 Years - 85 Years	CR-CSSS Champlain-Charles-Le Moyne
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy	NCT03802097	Gastric Cancer Complication of...	No use of antim... Use of antimicr...	18 Years - 75 Years	Korean South West East Gastric Surgery Group

Spots Global Cancer Trial Database for prophylactic antibiotics