Ertapenem Administered Subcutaneously Versus Intravenously

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Once the high mortality rate of the study site (about 60%, according to unpublished administrative information), it was decided to increase this number by 30% to compensate for possible losses, totaling 106 patients, 53 in each arm.

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

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Combination Product: Ertapenem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any type of cancer in palliative care; Urinary tract infection; Informed consent assigned by the patient or legal representative. Exclusion Criteria: Neutropenia; Unconsciousness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous Ertapenem<br>Patients with urinary tract infection will be treated with ertapenem by the intravenous route. | Combination Product: Ertapenem<br>* 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.<br>|
| Experimental: Subcutaneous Ertapenem<br>Patients with urinary tract infection will be treated with ertapenem by the subcutaneous route. | Combination Product: Ertapenem<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiological cure | negative uroculture at the end of the treatment | seven days for cystitis and fourteen days for pyelonephritis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | infusion related adverse events | 30 days | 
| clinical response | improve urinary tract symptoms after ertapenem treatment | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subcutaneous, ertapenem, urinary tract infection, advanced cancer, palliative care