Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration (ERTAPRO)
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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-
-
Paris、フランス、75908 Cedex 15
- HEGP Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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 :
- 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
Exclusion Criteria:
- 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
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：group A
One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection
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One single injection of 1g of ertapenem before surgery
|
|
実験的：group B
One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection
|
One single injection of 1g of ertapenem before surgery
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prostatic concentration of ertapenem
時間枠：at the time of surgery
|
To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.
|
at the time of surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prostatic concentration of ertapenem
時間枠：at the time of surgery
|
To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery
|
at the time of surgery
|
協力者と研究者
捜査官
- スタディチェア：Olivier Lortholary, Md, PhD、Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres
- 主任研究者：Marc-Olivier Timsit, Md, PhD、Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France.
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- Jimenez-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.
- Wells 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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