Benign Prostatic Hyperplasia (BPH) Requiring Surgical ResectionPhase 4ERTAPRONCT02041767
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
A Phase 4 study testing Ertapenem in people with Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection
- What is being tested?
- Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acceptance and understanding of the consent form (signed)
- 18-80 years old patients
- BPH needing endoscopic resection according to French Urology Association recommendations
- Procedure and follow up made in investigator center
- normal digital rectal examination
- PSA :
Show all 10Show fewer
- patient > 69 years old, not necessary
- patient < 69 years old, PSA<20 and if 4<PSA<20, the ratio free PSA/total PSA must be >10%
- patient with renal clearance >60 estimated with MDRD
- patient affiliated to the social security
Who cannot join
- personal or familial history of prostatic or genito-urinary cancer
- personal history of pelvic irradiation
- personal history of hormone-therapy
- personal history of prostatic adenomectomy by abdominal approach
- personal history of allergy to beta-lactamines
- urinary tract infection or bacterial colonisation at the time of procedure
Show all 10Show fewer
- carbapenems treatment in the two weeks before surgery
- hyperresponsivness to ertapenem or other carbapenems antibiotic
- patient with renal clearance estimated with MDRD <60
- patient with catheter or probe permanently
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.
Read the detailed description
Ertapenem is an antibiotic belonging to carbapenems family and used in infections with Gram-negative bacilli with extended spectrum beta lactamase (ESBL). Its efficacy has been demonstrated in abdominal, soft tissue, pulmonary, skin and gynaecological infections. Recently it has been compared to ceftriaxone in urinary infections demonstrating his efficacy and tolerance.
The purpose of this study is to assess its benefit in probabilistic strategy by demonstrating its prostatic diffusion in significant concentration when administrated in a pre-operative single injection.
Patients were divided in two groups receiving a single injection of 1g of ertapenem 1h or 12h before endoscopic surgery of prostate hyperplasia.
Concentration of ertapenem was measuring on blood sample and on chips resection of prostate during endoscopic surgery.
To demonstrate the prostatic diffusion in significant amount of ertapenem, the prostatic concentration of ertapenem had to be higher than the minimal inhibitory concentration (MIC) for 40% of the time of injection interval.
- Being tested
- Ertapenem
- Keywords
- Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
One single injection of 1g of ertapenem before surgery
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection Receives: Drug: Ertapenem |
| group B | Experimental | One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection Receives: Drug: Ertapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostatic concentration of ertapenem
To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.
Measured: at the time of surgery
Secondary outcomes (1)
Prostatic concentration of ertapenem
To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery
Measured: at the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia (BPH) Requiring Surgical ResectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Olivier Lortholary, Md, PhD, Study chair, Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de SèvresMarc-Olivier Timsit, Md, PhD, Principal investigator, Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041767
- Sponsor's protocol ID
- P090205
- Acronym
- ERTAPRO
- Status last verified
- Sep 2025
- First submitted
- 20 Jan 2014
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Alhambra A, Cuadros JA, Cacho J, Gomez-Garces JL, Alos JI. In vitro susceptibility of recent antibiotic-resistant urinary pathogens to ertapenem and 12 other antibiotics. J Antimicrob Chemother. 2004 Jun;53(6):1090-4. doi: 10.1093/jac/dkh218. Epub 2004 Apr 29.
PubMed 15117925Tomera 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.
PubMed 12183244Jimenez-Cruz F, Jasovich A, Cajigas J, Jiang Q, Imbeault D, Woods GL, Gesser RM; Protocol 021 Study Group. A prospective, multicenter, randomized, double-blind study comparing ertapenem and ceftriaxone followed by appropriate oral therapy for complicated urinary tract infections in adults. Urology. 2002 Jul;60(1):16-22. doi: 10.1016/s0090-4295(02)01664-3.
PubMed 12100914Wells WG, Woods GL, Jiang Q, Gesser RM. Treatment of complicated urinary tract infection in adults: combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii67-74. doi: 10.1093/jac/dkh208.
PubMed 15150185Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer J, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit M. Concentrations plasmatiques et intra-prostatiques d'ertapeneme apres administration preoperatoire : experience prospective monocentrique - etude ERTAPRO. Prog Urol. 2015 Nov;25(13):775. doi: 10.1016/j.purol.2015.08.121. No abstract available. French.
PubMed 26544316Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer JM, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit MO. Plasma and intraprostatic concentrations of ertapenem following preoperative single dose administration: a single-centre prospective experience and clinical implications-the ERTAPRO study. Int J Antimicrob Agents. 2016 Aug;48(2):168-74. doi: 10.1016/j.ijantimicag.2016.04.027. Epub 2016 Jun 2.
PubMed 27324263
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
- ClinicalTrials.gov ID
- NCT02041767
- Acronym / sponsor ID
- ERTAPRO / P090205
- Keywords
- Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, URC-CIC Paris Descartes Necker Cochin
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.
Detailed description
Ertapenem is an antibiotic belonging to carbapenems family and used in infections with Gram-negative bacilli with extended spectrum beta lactamase (ESBL). Its efficacy has been demonstrated in abdominal, soft tissue, pulmonary, skin and gynaecological infections. Recently it has been compared to ceftriaxone in urinary infections demonstrating his efficacy and tolerance.
The purpose of this study is to assess its benefit in probabilistic strategy by demonstrating its prostatic diffusion in significant concentration when administrated in a pre-operative single injection.
Patients were divided in two groups receiving a single injection of 1g of ertapenem 1h or 12h before endoscopic surgery of prostate hyperplasia.
Concentration of ertapenem was measuring on blood sample and on chips resection of prostate during endoscopic surgery.
To demonstrate the prostatic diffusion in significant amount of ertapenem, the prostatic concentration of ertapenem had to be higher than the minimal inhibitory concentration (MIC) for 40% of the time of injection interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: ErtapenemOne single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection |
| group B | Experimental | Drug: ErtapenemOne single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Acceptance and understanding of the consent form (signed)
- 18-80 years old patients
- BPH needing endoscopic resection according to French Urology Association recommendations
- Procedure and follow up made in investigator center
- normal digital rectal examination
Key exclusion criteria (10 listed)
- personal or familial history of prostatic or genito-urinary cancer
- personal history of pelvic irradiation
- personal history of hormone-therapy
- personal history of prostatic adenomectomy by abdominal approach
- personal history of allergy to beta-lactamines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErtapenemOne single injection of 1g of ertapenem before surgery | Drug | group A, group B |
Primary outcome
Prostatic concentration of ertapenem
Time frame: at the time of surgery
To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.
1 secondary outcome
Prostatic concentration of ertapenem
Time frame: at the time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 15117925Alhambra A, Cuadros JA, Cacho J, Gomez-Garces JL, Alos JI. In vitro susceptibility of recent antibiotic-resistant urinary pathogens to ertapenem and 12 other antibiotics. J Antimicrob Chemother. 2004 Jun;53(6):1090-4. doi: 10.1093/jac/dkh218. Epub 2004 Apr 29.
- Background: PubMed 12183244Tomera 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.
- Background: PubMed 12100914Jimenez-Cruz F, Jasovich A, Cajigas J, Jiang Q, Imbeault D, Woods GL, Gesser RM; Protocol 021 Study Group. A prospective, multicenter, randomized, double-blind study comparing ertapenem and ceftriaxone followed by appropriate oral therapy for complicated urinary tract infections in adults. Urology. 2002 Jul;60(1):16-22. doi: 10.1016/s0090-4295(02)01664-3.
- Background: PubMed 15150185Wells WG, Woods GL, Jiang Q, Gesser RM. Treatment of complicated urinary tract infection in adults: combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii67-74. doi: 10.1093/jac/dkh208.
- Results publication: PubMed 26544316Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer J, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit M. Concentrations plasmatiques et intra-prostatiques d'ertapeneme apres administration preoperatoire : experience prospective monocentrique - etude ERTAPRO. Prog Urol. 2015 Nov;25(13):775. doi: 10.1016/j.purol.2015.08.121. No abstract available. French.
- Results publication: PubMed 27324263Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer JM, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit MO. Plasma and intraprostatic concentrations of ertapenem following preoperative single dose administration: a single-centre prospective experience and clinical implications-the ERTAPRO study. Int J Antimicrob Agents. 2016 Aug;48(2):168-74. doi: 10.1016/j.ijantimicag.2016.04.027. Epub 2016 Jun 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Lortholary, Md, PhD study chair
Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres
Marc-Olivier Timsit, Md, PhD principal investigator
Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertapenem in people with Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostatic concentration of ertapenem (time frame: at the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02041767, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.