Efficacy and Safety of Colistin Based Antibiotic Therapy
Efficacy and Safety of Colistin Based Antibiotic Therapy for Multidrug Resistant Gram Negative Infections in Pediatric Intensive Care Unit
To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit.
The main outcome measure is clinical and microbiological responses to therapy.
The secondary outcome is the occurrence of adverse events during Colistin combination treatment.
調査の概要
詳細な説明
Patients and Methods
Design of the study:
- Prospective, Randomized, interventional study.
Setting:
- The study will be conducted in the pediatric surgery intensive care unit in Children's Hospitals, Ain Shams University, Cairo, Egypt.
Subjects:
- Pediatric patients admitted in pediatric surgery intensive care unit.
Inclusion criteria:
All children with culture-proven nosocomial infections due to multidrug resistance gram-negative organisms
Exclusion criteria:
- Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded.
- Patients who will receive <6 doses of intravenous Colistin will be excluded.
- Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.
Methodology:
- Sixty pediatric patients admitted to the pediatric surgery intensive care unit will be enrolled in the study and will be randomly assigned to either Group I or Group II
Group I: Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24 Colistin formulation consists of 2 million IU per vial. Group II: Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬. 22,24
For all patients the following data will be collected:
- Demographic data (age, gender, weight).
- The risk factors for nosocomial infections.
- Pediatric surgery intensive care unit stay.
- Type of surgeries performed.
- Site of isolation of organisms.
- The dose and duration of therapy.
- Serum creatinine levels will be assessed at baseline, once weekly and at the end of Colistin combination therapy.
- Nephrotoxic co-medication monitoring.
- Clinical (resolution of signs and symptoms of infection) and
- microbiological (bacteriologic responses) outcomes will be evaluated during treatment and at the end of the treatment.
According to the inclusion and exclusion criteria, the demographic data for the intended ICU patients was collected, then the sample was withdrawn from the infected site to be cultured on specific culture media (such as blood agar, MacConkey agar, Chocolate agar), and identification of the isolated microorganism was detected by biochemical tests and Vitek-2 compact system whenever required. Antimicrobial sensitivity to Colistin was tested using the micro broth dilution method, in order to be evaluated in Colistin therapy. After culture-proven, the drug was given, either IV Colistin-Imipenem/Cilastatin as a combination or Imipenem/Cilastatin as a monotherapy. Throughout this step, the hemodynamic parameters were measured during the process of treatment, without neglecting the serum creatinine level to detect any nephrotoxicity.
We assure the right drug handling, dosing, dispensing, and monitoring. At the end of the treatment, the duration and length of PICU stay were recorded.
The decision and/or conclusion of treatment failure and/ or success was based upon the worsening and/or improvement of the patients' parameters and their situation including the results of the microbiological examination before and after the intervention
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Cairo、エジプト
- Ain Shams Univesity Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- All children with culture proven nosocomial infections due to multidrug resistance gram-negative organisms
Exclusion Criteria:
1. Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded.
2. Patients who will receive <6 doses of intravenous Colistin will be excluded.
3. Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.
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:他の
- 割り当て: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 |
---|---|
他の:Montherapy
Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours
|
Imipenem and cilastatin sodium
他の名前:
Health caregivers give the drug to the patients and monitoring the infusion rate
|
他の:Combination
Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24
Colistin formulation consists of 2 million IU per vial.
|
Imipenem and cilastatin sodium
他の名前:
Health caregivers give the drug to the patients and monitoring the infusion rate
|
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 |
---|---|---|
Hemodynamic Parameters Measurement ,heart beating rate.
時間枠:2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the heart beating rate.
|
2 year
|
Hemodynamic Parameters Measurement ,body temperature
時間枠:2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the body temperature
|
2 year
|
Hemodynamic Parameters Measurement ,respiratory rate.
時間枠:2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the respiratory rate.
|
2 year
|
Hemodynamic Parameters Measurement ,blood pressure
時間枠:2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the blood pressure
|
2 year
|
Hemodynamic Parameters Measurement ,partial oxygen saturation pressure
時間枠:2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the partial oxygen saturation pressure
|
2 year
|
Hemodynamic Parameters Measurement and Septic Markers, serum lactate
時間枠:2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the serum lactate
|
2 year
|
Hemodynamic Parameters Measurement ,serum creatinine
時間枠:2 year
|
the efficacy and safety of antibiotic combination containing Colistin.
We will monitor the serum creatinine
|
2 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:AHMED S ATTIA、Heliopolis University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 210
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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