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Ertapenem Administered Subcutaneously Versus Intravenously

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ClinicalTrials.gov Identifier: NCT03218800
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Luciana Ramadas, Instituto Nacional de Cancer, Brazil

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infections Combination Product: Ertapenem Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ertapenem Administered Subcutaneously Versus Intravenously for Urinary Tract Infections in Oncological Palliative Care Patients: a Randomized, Open, Non-inferiority Clinical Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous Ertapenem
Patients with urinary tract infection will be treated with ertapenem by the intravenous route.
Combination Product: Ertapenem

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.


Experimental: Subcutaneous Ertapenem
Patients with urinary tract infection will be treated with ertapenem by the subcutaneous route.
Combination Product: Ertapenem

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.





Primary Outcome Measures :
  1. microbiological cure [ Time Frame: seven days for cystitis and fourteen days for pyelonephritis ]
    negative uroculture at the end of the treatment


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 30 days ]
    infusion related adverse events

  2. clinical response [ Time Frame: 14 days ]
    improve urinary tract symptoms after ertapenem treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218800


Contacts
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Contact: Luciana Ramadas, MD 552132073924 luramadas@yahoo.com.br

Locations
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Brazil
INCA Instituto Nacional do Cancer Recruiting
Rio de Janeiro, Brazil, 20560-120
Contact: Luciana Ramadas         
Principal Investigator: Luciana Ramadas         
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Investigators
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Study Chair: Luciana Ramadas INCA- Instituto Nacional de Câncer

Additional Information:
Publications:
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Responsible Party: Luciana Ramadas, MD, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT03218800     History of Changes
Other Study ID Numbers: Ertapsubcut
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Luciana Ramadas, Instituto Nacional de Cancer, Brazil:
subcutaneous
ertapenem
urinary tract infection
advanced cancer
palliative care

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents