Ertapenem Administered Subcutaneously Versus Intravenously

NCT03218800 | Terminated Phase 3 DMC

• 1 other identifier: Ertapsubcut
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

subcutaneous; ertapenem; urinary tract infection; advanced cancer; palliative care

Outcome Measures

Primary Outcomes (1)

• microbiological cure

  negative uroculture at the end of the treatment

  seven days for cystitis and fourteen days for pyelonephritis

Secondary Outcomes (2)

• adverse events

  30 days

• clinical response

  14 days

Study Arms (2)

Intravenous Ertapenem

ACTIVE COMPARATOR

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

Combination Product: Ertapenem

Subcutaneous Ertapenem

EXPERIMENTAL

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

Combination Product: Ertapenem

Interventions

Ertapenem COMBINATION_PRODUCT

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.

Intravenous Ertapenem; Subcutaneous Ertapenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any type of cancer in palliative care;
• Urinary tract infection;
• Informed consent assigned by the patient or legal representative.

You may not qualify if:

• Neutropenia;
• Unconsciousness.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

INCA Instituto Nacional do Cancer

Rio de Janeiro, 20560-120, Brazil

Location

Related Publications (5)

• Forestier E, Gros S, Peynaud D, Levast M, Boisseau D, Ferry-Blanco C, Labe A, Lecomte C, Rogeaux O. [Ertapenem administered intravenously or subcutaneously for urinary tract infections caused by ESBL producing enterobacteriacea]. Med Mal Infect. 2012 Sep;42(9):440-3. doi: 10.1016/j.medmal.2012.07.005. Epub 2012 Aug 25. French.

  PMID: 22925551 BACKGROUND

• Frasca D, Marchand S, Petitpas F, Dahyot-Fizelier C, Couet W, Mimoz O. Pharmacokinetics of ertapenem following intravenous and subcutaneous infusions in patients. Antimicrob Agents Chemother. 2010 Feb;54(2):924-6. doi: 10.1128/AAC.00836-09. Epub 2009 Nov 23.

  PMID: 19933804 BACKGROUND

• Grigoryan L, Trautner BW, Gupta K. Diagnosis and management of urinary tract infections in the outpatient setting: a review. JAMA. 2014 Oct 22-29;312(16):1677-84. doi: 10.1001/jama.2014.12842.

  PMID: 25335150 BACKGROUND

• Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.

  PMID: 23268518 BACKGROUND

• Tomera KM, Burdmann EA, Reyna OG, Jiang Q, Wimmer WM, Woods GL, Gesser RM; Protocol 014 Study Group. Ertapenem versus ceftriaxone followed by appropriate oral therapy for treatment of complicated urinary tract infections in adults: results of a prospective, randomized, double-blind multicenter study. Antimicrob Agents Chemother. 2002 Sep;46(9):2895-900. doi: 10.1128/AAC.46.9.2895-2900.2002.

  PMID: 12183244 BACKGROUND

Related Links

• ertapenem prescribing information
• Power calculator for binary outcome non-inferiority trial

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Luciana Ramadas

  INCA- Instituto Nacional de Câncer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 17, 2017
• Study Start: June 1, 2017
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)