Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colonic Neoplasms

Rectal Neoplasms

Diverticulum

Diverticular Diseases

Diverticulosis, Colonic

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Anti-Infective Agents

All Drugs and Chemicals

Ertapenem

Anti-Bacterial Agents

powder for infusion, 1 gram I.V., single dose over 30 min.

Doris Henne-Bruns, Prof. Dr.

The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.

The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.

Concentration of Ertapenem in Colorectal Tissue

Konzentrationen Von Ertapenem in Kolorektalem Gewebe

The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours

University of Ulm

Administration of 1 gram ertapenem I.V.

Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min.

Age, Categorical

Age, Continuous

Gender

Germany

Region of Enrollment

Prof. Dr. Henne-Bruns, PI

Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..

Safety Assessment

Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue

Overall Study

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Urinary Bladder Neoplasms

Communicable Diseases

Urinary Tract Infections

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urinary Bladder Diseases

Antineoplastic Agents

Anti-Dyskinesia Agents

Micronutrients

Hematinics

Vitamins

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Levofloxacin

Ofloxacin

Antibiotics, Antitubercular

Nitrofurantoin

Trimethoprim, Sulfamethoxazole Drug Combination

Trimethoprim

Sulfamethoxazole

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

Diary

Trimethoprim-Sulfamethoxazole

Khurshid A. Guru

Khurshid A Guru

This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

PRIMARY OBJECTIVE:

I. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy.

SECONDARY OBJECTIVE:

I. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ANTIBIOTIC): Patients receive ertapenem orally (PO), levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

GROUP II (CONTROL): Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

After surgery, patients are followed up to 120 days.

Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy

Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.

stratified logistic regression models (stratified by antibiotic use)

Will be evaluated in patients who received prophylactic antibiotics.

To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively.

Roswell Park Cancer Institute

Pharmaceutical Solutions

Patients with urinary tract infection will be treated with ertapenem by the intravenous route.

Patients with urinary tract infection will be treated with ertapenem by the subcutaneous route.

Dose: 1g per day if creatinine clearance \> 30mL/min or 500 mg per day if creatinine clearance \< 30mL/min.

Dilution: 50 ml saline solution. Duration 30 minutes.

Luciana Ramadas

Infections requiring intravenous antimicrobial therapy are very common events in patients with advanced cancer. Nevertheless, these patients frequently present vascular damages becoming extremely difficult to access and maintain intravenous route for hydration and nutritional support. In this context, the subcutaneous route could be implemented as an alternative route for replacement of fluids, electrolytes and drugs. Few studies have evaluated the possibility of using the subcutaneous route for treatment of infections though.

Patients in palliative care often have infections caused by multidrug resistant bacterial such as beta-lactamase producing bacteria. In this context, we hypothesize Ertapenem subcutaneously is not inferior to the same drug intravenously for the treatment of urinary infections in patients on oncologic palliative care. A non-inferiority clinical trial would be adequate and could provide stronger evidence on the possibility of this alternative route for antibiotic therapy in urinary tract infections, with important advantages such as greater convenience of use.

This is a randomized open label clinical trial to evaluate Ertapenem administered subcutaneously is non-inferior to the same antibiotic intravenously to treat urinary tract infections in oncological palliative care patients.

The study will be performed at the Palliative Care Unit (PCU) of the National Cancer Institute of Brazil José Alencar Gomes da Silva (INCA), a 56-bed hospital and the only public hospital for cancer palliative care located in the city of Rio de Janeiro, Brazil.

A sample of 82 patients was estimated, considering the level of significance (alpha) of unilateral 2.5%, the power of the study (1-beta) of 80%, the non-inferiority limit of 4%, and success percentages in the groups control and experimental studies of 92% and 100%, respectively. Once the high mortality rate of the study site (about 60%, according to unpublished administrative information), it was decided to increase this number by 30% to compensate for possible losses, totaling 106 patients, 53 in each arm.

Ertapenem Administered Subcutaneously Versus Intravenously

Ertapenem Administered Subcutaneously Versus Intravenously for Urinary Tract Infections in Oncological Palliative Care Patients: a Randomized, Open, Non-inferiority Clinical Trial

negative uroculture at the end of the treatment

improve urinary tract symptoms after ertapenem treatment

Instituto Nacional de Cancer, Brazil

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Concentration of Ertapenem in Colorectal Tissue	NCT00535652	Diverticulosis,... Rectal Neoplasm... Colonic Neoplas...	Ertapenem	18 Years - 90 Years	University of Ulm
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	NCT04502095	Bladder Carcino... Refractory Blad... Urinary Tract I...	Clindamycin Diary Ertapenem Levofloxacin Nitrofurantoin Trimethoprim-Su...	18 Years -	Roswell Park Cancer Institute
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	NCT04502095	Bladder Carcino... Refractory Blad... Urinary Tract I...	Clindamycin Diary Ertapenem Levofloxacin Nitrofurantoin Trimethoprim-Su...	18 Years -	Roswell Park Cancer Institute
Ertapenem Administered Subcutaneously Versus Intravenously	NCT03218800	Urinary Tract I...	Ertapenem	18 Years -	Instituto Nacional de Cancer, Brazil

Spots Global Cancer Trial Database for ertapenem

Every month we try and update this database with for ertapenem cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ertapenem

Every month we try and update this database with for ertapenem cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ertapenem cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.