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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

Tracking Information
First Submitted Date  ICMJE July 6, 2017
First Posted Date  ICMJE July 17, 2017
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
microbiological cure [ Time Frame: seven days for cystitis and fourteen days for pyelonephritis ]
negative uroculture at the end of the treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03218800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • adverse events [ Time Frame: 30 days ]
    infusion related adverse events
  • clinical response [ Time Frame: 14 days ]
    improve urinary tract symptoms after ertapenem treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ertapenem Administered Subcutaneously Versus Intravenously
Official Title  ICMJE Ertapenem Administered Subcutaneously Versus Intravenously for Urinary Tract Infections in Oncological Palliative Care Patients: a Randomized, Open, Non-inferiority Clinical Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Tract Infections
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Active Comparator: Intravenous Ertapenem
    Patients with urinary tract infection will be treated with ertapenem by the intravenous route.
    Intervention: Combination Product: Ertapenem
  • Experimental: Subcutaneous Ertapenem
    Patients with urinary tract infection will be treated with ertapenem by the subcutaneous route.
    Intervention: Combination Product: Ertapenem
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2017)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luciana Ramadas, MD 552132073924 luramadas@yahoo.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03218800
Other Study ID Numbers  ICMJE Ertapsubcut
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Luciana Ramadas, Instituto Nacional de Cancer, Brazil
Study Sponsor  ICMJE Instituto Nacional de Cancer, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Luciana Ramadas INCA- Instituto Nacional de Câncer
PRS Account Instituto Nacional de Cancer, Brazil
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP