- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07643974
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Christopher R Riegner, MPH
- Número de teléfono: 202-877-1000
- Correo electrónico: christopher.r.riegner@medstar.net
Copia de seguridad de contactos de estudio
- Nombre: Inger H Ljungberg, MPH
- Número de teléfono: 202-877-1000
- Correo electrónico: inger.h.ljungberg@medstar.net
Ubicaciones de estudio
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20010
- MedStar National Rehabilitation Hospital
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Contacto:
- Chris Riegner, MPH
- Número de teléfono: 2028771000
- Correo electrónico: christopher.r.riegner@medstar.net
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Investigador principal:
- Amanda Garver, DO
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- University of Pittsburgh Medical Center
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Contacto:
- Chris Riegner, MPH
- Número de teléfono: 2028771000
- Correo electrónico: christopher.r.riegner@medstar.net
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Investigador principal:
- Catherine Forster, MD, MS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
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Experimental: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Level of Lactobacillus rhamnosus GG in Urine
Periodo de tiempo: 24 hours after final LGG instillation
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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.
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24 hours after final LGG instillation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Length of Recolonization
Periodo de tiempo: 28 days after final Lactobacillus instillation
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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.
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28 days after final Lactobacillus instillation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amanda Garver, DO, MedStar National Rehabilitation Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Infecciones
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Anomalías congénitas
- Trauma, Sistema Nervioso
- Enfermedades de la vejiga urinaria
- Malformaciones del Sistema Nervioso
- Defectos del tubo neural
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Esclerosis múltiple
- Lesiones de la médula espinal
- Infecciones del tracto urinario
- Disrafismo Espinal
- Vejiga Urinaria Neurogénica
- Enfermedades de la médula espinal
- Carbohidratos
- Glucósidos
- Aminoglucósidos
- Gentamicinas
Otros números de identificación del estudio
- STUDY00009848
- HT94252410372 (Otro número de subvención/financiamiento: United States Department of Defense eBRAP)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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