- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00732238
Multifaceted Treatment of Catheter-related Urinary Tract Infection
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
UTI is the most common infection in patients with spinal cord injury who require a catheter to drain urine from their bladder. These infections can cause serious medical complications, such as bloodstream infection, decreased kidney function, prolonged hospitalization, and add great cost. Unfortunately, the treatment of catheter-related urinary tract infection has not been standardized in this population in terms of:
- the need to replace the indwelling catheter;
- the necessity to provide antibiotic coverage against all organisms grown from urine cultures; and
- the duration of antibiotic treatment.
The prevalent, though not scientifically well supported approach for treating catheter-related lower UTI in patients with spinal cord injury comprises the following:
- Retaining the original bladder catheter in place upon diagnosis of infection because of the theoretical concern that removal of the infected catheter may potentially cause the infecting organism to move from the bladder to the bloodstream (bacteremia). This theoretical complication, however, is very unlikely and even if it does occur, the bacteria would only remain in the bloodstream for a very short period of time and would not have a significant impact on the patient. In contrast, we propose that immediate removal of the original indwelling bladder catheter with its film of protected bacteria can enhance resolution of UTI.
- Providing antibiotic coverage against all organisms which grow from a urine culture that is obtained from the original indwelling bladder catheter. Although this source of urine culture is a sensitive method for identifying the organisms that are present in the urine, it suffers from poor specificity because it may yield the growth of some organisms that could have colonized the catheter (and, therefore, grown in a culture of urine obtained through that original catheter) but did not contribute to UTI. This issue is particularly problematic in patients with spinal cord injury because urine cultures in almost half of the cases of UTI in this population yield multiple bacteria. Therefore, we propose that collection of a urine culture while inserting the new bladder catheter would yield growth of only organisms that truly contribute to UTI and, therefore, obviate the need to administer unnecessary antibiotics to cover additional organisms that would grow only from urine cultures obtained through the original catheter.
- Treatment with systemic antibiotics for 10 days. There exists, however, no prospective randomized clinical trials indicating that this duration of antibiotic therapy is optimal in patients with spinal cord injury. Since catheter-free, able-bodied patients with lower UTI are successfully treated with courses of antibiotics as short as 1-3 days, we propose that by removing the focus of infection (i.e. the original catheter) a 5-day course of systemic antibiotics would be sufficient for treating catheter-related lower UTI in patients with spinal cord injury.
The results of this research are expected to provide the following major benefits to veterans with spinal cord injury:
- the multifaceted approach will provide highly effective treatment of UTI;
- the lower number of antibiotics that are administered to cover the organisms grown from urine cultures obtained at the time of inserting the replacement bladder catheter will result in lower cost of treatment and a reduced risk for developing antibiotic resistance;
- the shorter duration of antibiotic course will decrease the overall cost of treatment, reduce hospital stay, and shorten rehabilitation down time.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- Michael E. DeBakey VA Medical Center (152)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult patients with SCI who are hospitalized at the Michael E. Debakey VA Medical Center and suffer from lower UTI associate with an indwelling transurethral or suprapubic bladder catheter will be enrolled in the study
Exclusion Criteria:
- Exclusion criteria will include septicemia, chronic antimicrobial therapy and inability, or unwillingness to give informed consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Arm 1
Removal of Bladder Catheter.
Urine Culture Post Catheter Removal.
Shorter Duration of Antibiotic Therapy.
|
By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen.
In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.
|
Aktiv komparator: Arm 2
Urinary Catheter Is Not Exchanged.
Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter.
Longer Duration of Antibiotic Therapy.
|
Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect
Tidsram: Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)
|
Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy
Tidsram: Up to 180 days of end of therapy
|
Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf)
|
Up to 180 days of end of therapy
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Rabih O Darouiche, MD, Michael E. DeBakey VA Medical Center (152)
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Urologiska sjukdomar
- Sjukdomar i urinblåsan
- Neurologiska manifestationer
- Sår och skador
- Sjukdomsegenskaper
- Trauma, nervsystemet
- Ryggmärgssjukdomar
- Infektioner
- Smittsamma sjukdomar
- Urinvägsinfektion
- Ryggmärgsskador
- Urinblåsa, neurogen
- Anti-infektionsmedel
- Antibakteriella medel
Andra studie-ID-nummer
- B4747-P
- H-18309 (Annat bidrag/finansieringsnummer: Baylor College of Medicine)
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