Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
Effect of Dose Timing of Coupled Intravesical Gentamicin and Lactobacillus Rhamnosus LGG on Success and Length of Colonization in Men and Women With SCI/D and NLUTD
調査の概要
状態
詳細な説明
People with spinal cord injury/disease (SCI/D) experience, on average, 2.5 episodes of UTI annually. Since repeated exposures of bacteria to antibiotics leads to multi-drug resistant organisms (MDROs), it is likely that the frequent use of antibiotics for UTI is a driver of the increasing prevalence of infections with MDROs in the SCI/D population. This prevalence of MDROs among people with SCI/D represents a microcosm of the world-wide public health crisis of antibiotic resistance. As stated by the CDC, "antibiotic resistance is one of the biggest public health challenges of our time." In the US alone, 2.8M people annually develop infections with resistant microbes; of whom 35,000 die as a direct result. Infections with resistant organisms are associated with longer hospital lengths of stay, increased mortality, and higher health care costs. With UTI persistently being the leading reason for rehospitalizations among people with SCI/D, infections with resistant organisms represent a contributor to elevated health care costs as well as mortality risk. Additionally, the cost to treat a UTI due to an extended-spectrum beta-lactamase (ESBL) organism is estimated to be 1.5 times greater than treating a non-ESBL pathogen. Thus, not only are people with SCI/D and UTI at greater risk of mortality due to MDROs, they are also likely to have higher costs as a result of UTI. These costs can only be expected to increase, as the rate of antibiotic resistant UTIs increases. Moreover, individuals with SCI/D and NLUTD experience lower urinary tract symptoms (LUTS) frequently, and these may be treated with antibiotics whether they represent UTI or not.
As noted earlier, the standard of care for UTI treatment (systemic antibiotics, guided by standard urine culture (SUC)) is flawed and contributes to overtreatment and antimicrobial resistance. Use of intravesical therapeutics have been a part of clinical practice since the 1960's and intravesical antibiotics have been studied for nearly 30 years; however, use of intravesical antibiotics for UTI is typically only considered as a "last resort" (such as for recurrent UTI). Agents used include gentamicin, tobramycin, colistin, and neomycin/polymyxin. Gentamicin is the most commonly studied intravesical antibiotic and when administered intravesicularly, it has been shown to have little to no systemic absorption, nor nephro- or oto-toxicity (as with intravenous administration). Intravesical gentamicin has been shown to be safe, tolerated, and effective for recurrent UTI in people with NLUTD.
The investigators' team was first to compare the urobiomes of people with SCI/D and NLUTD to those of neurologically intact controls. This work verified the existence of the urobiome, showing that most control female urobiomes are predominated by Lactobacillus and some control male urobiomes contain Lactobacillus, but most do not. The investigators also showed that NLUTD urobiomes are dysbiotic, depleted in beneficial bacteria as most NLUTD females lacked or had reduced Lactobacillus levels, while most NLUTD males lacked the Streptococcus and/or Corynebacterium that was commonly observed in control males. These results support the investigators' hypothesis that NLUTD bladders of most females and at least some males could be colonized by LGG, and that LGG in the urobiome could improve urinary symptoms.
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前:Christopher R Riegner, MPH
- 電話番号:202-877-1000
- メール:christopher.r.riegner@medstar.net
研究連絡先のバックアップ
- 名前:Inger H Ljungberg, MPH
- 電話番号:202-877-1000
- メール:inger.h.ljungberg@medstar.net
研究場所
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20010
- MedStar National Rehabilitation Hospital
-
コンタクト:
- Chris Riegner, MPH
- 電話番号:2028771000
- メール:christopher.r.riegner@medstar.net
-
主任研究者:
- Amanda Garver, DO
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15224
- University of Pittsburgh Medical Center
-
コンタクト:
- Chris Riegner, MPH
- 電話番号:2028771000
- メール:christopher.r.riegner@medstar.net
-
主任研究者:
- Catherine Forster, MD, MS
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Neurologic diagnosis
- ≥18 years old
- Neurogenic bladder for at least 6 months
- No USQNB-IC A, B1, or B2 symptoms
- No currently diagnosed UTI (within 24 hours of initiating instillations)
- Community dwelling (not in acute hospital setting)
Exclusion Criteria:
- Known genitourinary pathology beyond NLUTD (i.e. kidney stones, bladder stones, vesicoureteral reflux, etc.)
- Use of prophylactic antibiotics or any antibiotics within 2 weeks of beginning instillations
- Instillation of intravesical agents other than saline bladder wash
- Immunodeficiency
- Psychologic or psychiatric conditions influencing the ability to follow instructions
- Allergy to ampicillin, daptomycin, gentamicin/gentamycin, or probiotics
- Participation in another study which could confound results
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: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:Low Dose
Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL.
50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging.
Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers.
Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization; the solution will be left indwelling until the next catheterization.
This will be done six times.
Low dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin.
Low dose participants will do this in once in the evening and again 12 hours later (the following morning).
This mixture will remain in the bladder for at least 4 hours.
|
Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL.
50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging.
Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers, with the extra syringe being included in case of damage or accidental dropping of one of the six instillations.
Patients will be instructed to refrigerate all syringes immediately upon receipt.
The first instillation will occur after the first catheterization of the morning.
Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization and the solution has reach room temperature; the solution will be left indwelling for at least four hours.
This will be done every 12 hours for three days (6 doses).
Participants will be instructed to mix the contents of 1 LGG capsule into 45cc sterile 0.9% saline.
After mixing, participants will draw up the 45cc liquid LGG mixture into a 60 cc syringe and instill the first dose via the intermittent catheter after the last catheterization prior to going to bed.
Participants will receive 4 or 6 LGG capsules (2 additional capsules/participant, depending on randomization group) and will repeat this process every 12 hours until s/he has completed assigned dosing, according to randomization group.
The first LGG instillation will occur 72 hours after the final dose of gentamicin.
他の名前:
|
|
実験的:High Dose
Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL.
50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging.
Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers.
Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization; the solution will be left indwelling until the next catheterization.
This will be done six times.
High dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin.
High dose participants will do this in once in the evening, and again every 12 hours until four doses are complete.
This mixture will remain in the bladder for at least 4 hours.
|
Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL.
50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging.
Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers, with the extra syringe being included in case of damage or accidental dropping of one of the six instillations.
Patients will be instructed to refrigerate all syringes immediately upon receipt.
The first instillation will occur after the first catheterization of the morning.
Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization and the solution has reach room temperature; the solution will be left indwelling for at least four hours.
This will be done every 12 hours for three days (6 doses).
Participants will be instructed to mix the contents of 1 LGG capsule into 45cc sterile 0.9% saline.
After mixing, participants will draw up the 45cc liquid LGG mixture into a 60 cc syringe and instill the first dose via the intermittent catheter after the last catheterization prior to going to bed.
Participants will receive 4 or 6 LGG capsules (2 additional capsules/participant, depending on randomization group) and will repeat this process every 12 hours until s/he has completed assigned dosing, according to randomization group.
The first LGG instillation will occur 72 hours after the final dose of gentamicin.
他の名前:
|
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 |
|---|---|---|
|
Level of Lactobacillus rhamnosus GG in Urine
時間枠:24 hours after final LGG instillation
|
Urine samples will be analyzed with qPCR to determine whether LGG is present and, if so, at what concentration.
Concentration from 24 hours after final LGG instillation will be compared to that measured after final gentamicin instillation.
An increase of 30% or greater from baseline will be considered successful recolonization if LGG is present at baseline, otherwise absolute increase will be used.
|
24 hours after final LGG instillation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of Recolonization
時間枠:28 days after final Lactobacillus instillation
|
Urine samples collected at 7 days, 14 days, and 28 days after final Lactobacillus instillation will be analyzed with qPCR to determine if Lactobacillus is present, and if so, at what concentration.
These values will be compared with the samples taken after gentamicin instillations and 24 hours after final LGG instillation to determine how long increased LGG values persist.
|
28 days after final Lactobacillus instillation
|
協力者と研究者
捜査官
- 主任研究者:Amanda Garver, DO、MedStar National Rehabilitation Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- STUDY00009848
- HT94252410372 (その他の助成金/資金番号:United States Department of Defense eBRAP)
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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