Ertapenem Administered Subcutaneously Versus Intravenously

NCT ID: NCT03218800

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2021-02-28

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 Once the high mortality rate of the study site (about 60%, according to unpublished administrative information), it was decided to increase this number by 30% to compensate for possible losses, totaling 106 patients, 53 in each arm.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous Ertapenem

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

Group Type: ACTIVE_COMPARATOR

Ertapenem

Intervention Type: 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.

Subcutaneous Ertapenem

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

Group Type: EXPERIMENTAL

Ertapenem

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Luciana Ramadas

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciana Ramadas

Role: STUDY_CHAIR

INCA- Instituto Nacional de Câncer

Locations

INCA Instituto Nacional do Cancer

Rio de Janeiro, , Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 22925551 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19933804 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25335150 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23268518 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12183244 (View on PubMed)

Related Links

https://www.merck.com/product/usa/pi_circulars/i/invanz/invanz_pi.pdf

ertapenem prescribing information

https://www.sealedenvelope.com/power/binary-noninferior/

Power calculator for binary outcome non-inferiority trial

Other Identifiers

Ertapsubcut

Identifier Type: -

Identifier Source: org_study_id