Clinical trial · Interventional
Ertapenem Administered Subcutaneously Versus Intravenously
Ertapenem Administered Subcutaneously Versus Intravenously for Urinary Tract Infections in Oncological Palliative Care Patients: a Randomized, Open, Non-inferiority Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): not enough participants due to COVID19 pandemia
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Tract Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ertapenem | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intravenous Ertapenem
- description
- Patients with urinary tract infection will be treated with ertapenem by the intravenous route.
- interventionNames
- Combination Product: Ertapenem
- type
- EXPERIMENTAL
- label
- Subcutaneous Ertapenem
- description
- Patients with urinary tract infection will be treated with ertapenem by the subcutaneous route.
- interventionNames
- Combination Product: Ertapenem
Primary outcomes (1)
- measure
- microbiological cure
- timeFrame
- seven days for cystitis and fourteen days for pyelonephritis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDForestier 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
- BACKGROUNDFrasca 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
- BACKGROUNDGrigoryan 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
- BACKGROUNDPiaggio 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
- BACKGROUNDTomera 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