Antibiotic Irrigations for Intra-Abdominal Drains (AID)
Primary Purpose
Abdominal Abscess
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gentamicin Sulfate Inj 20mg/2ml vial for injection
Clindamycin phosphate 6 mg/1ml for injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Abscess
Eligibility Criteria
Inclusion Criteria:
- Intra-abdominal abscess drained with catheter/drain
- Treatment with systemic antibiotics
- Able to consent
Exclusion Criteria:
- Abscess(es) not amendable for an image guided drain placement.
Sites / Locations
- The University of IowaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Antibiotic Irrigation
Normal Saline Irrigation
Arm Description
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
The drain will be irrigated twice/day with normal saline
Outcomes
Primary Outcome Measures
Duration of systemic antibiotics
Total duration of systemic antibiotics will be recorded from the start of the treatment until discontinuation by primary care team. This will be measured as days from diagnosis to when the antibiotic treatment gets interrupted. Duration of systemic antibiotics will be our primary outcome measurement. Duration of systemic antibiotics will be monitored as an indication of the effectiveness of the proposed intervention.
Secondary Outcome Measures
White Blood Count
White blood count level from the blood draw will be measured starting from the admission until discharge or discontinuation by primary care team. During follow up, if white blood count will be measured, will record up to 1 month follow up. The white blood count will be measured once daily and as needed depending on clinical changes. We will plan to trend WBC as another indication of decreasing systemic inflammation.
Change in temperature
Temperature will be measured every 8 hours starting from admission and until patient discharge. And also temperature will be measured during each follow up clinic visit. Change in temperature is monitored as an indication of decrease systemic inflammation.
Changes in size of the Abscess
CT scan of would have been obtained prior to image guided drain placement. Any subsequent CT scans up to 1 month follow up upon discharge will be reviewed to assess changes in size of the abscess. This will be monitored for assessing the effectiveness of intervention.
Changes in Drain Output
Drain will have certain output that is recorded daily. Daily drain output will be in unit of ml and will be monitored as a measurement of abscess resolution.
Duration of drain
The total duration of the drain placement will be recorded in days starting from the day of placement up to drain removal and monitored as a effectiveness of the intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03476941
Brief Title
Antibiotic Irrigations for Intra-Abdominal Drains
Acronym
AID
Official Title
Antibiotic Irrigations for Intra-Abdominal Drains
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paolo Goffredo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. Current standard of care includes drain placement in the abscess cavity to reach source control as well as administration of systemic antibiotics. It is common practice to flush the drain on a daily basis to ensure patency. This study aims to analyze the clinical impact of a higher local concentration of antibiotics (rather than normal saline) provided through drain irrigation with an antimicrobial agent (Gentamicin and/or Clindamycin) compare to normal saline.
Detailed Description
People with an abdominal abscess who undergo drain placement will have those drains irrigated twice/day with either normal saline (placebo group) or with the above antibiotic solution for a total of 7 days or less if the drain were to be removed earlier. Outcomes of interest are duration of systemic antibiotics, and WBC and temperature curve.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Abscess
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
There will be two group, study and control group. In control group, patient will receive standard intra-abdominal drain care with daily flushing of the drain with normal saline. In study group, patient will receive daily flush with antibiotic for 7 days.
Masking
Participant
Masking Description
Written consent will be obtained from all participants. Then, each participant will be randomized into two arms. Nurse will administer the drain flush either with normal saline or antibiotic irrigation.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic Irrigation
Arm Type
Experimental
Arm Description
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
Arm Title
Normal Saline Irrigation
Arm Type
Placebo Comparator
Arm Description
The drain will be irrigated twice/day with normal saline
Intervention Type
Drug
Intervention Name(s)
Gentamicin Sulfate Inj 20mg/2ml vial for injection
Intervention Description
Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.
Intervention Type
Drug
Intervention Name(s)
Clindamycin phosphate 6 mg/1ml for injection
Intervention Description
Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo group will receive drain irrigation twice/day
Primary Outcome Measure Information:
Title
Duration of systemic antibiotics
Description
Total duration of systemic antibiotics will be recorded from the start of the treatment until discontinuation by primary care team. This will be measured as days from diagnosis to when the antibiotic treatment gets interrupted. Duration of systemic antibiotics will be our primary outcome measurement. Duration of systemic antibiotics will be monitored as an indication of the effectiveness of the proposed intervention.
Time Frame
From initiation of systemic treatment until 1 month follow up
Secondary Outcome Measure Information:
Title
White Blood Count
Description
White blood count level from the blood draw will be measured starting from the admission until discharge or discontinuation by primary care team. During follow up, if white blood count will be measured, will record up to 1 month follow up. The white blood count will be measured once daily and as needed depending on clinical changes. We will plan to trend WBC as another indication of decreasing systemic inflammation.
Time Frame
From initiation of systemic treatment until 1 month follow up
Title
Change in temperature
Description
Temperature will be measured every 8 hours starting from admission and until patient discharge. And also temperature will be measured during each follow up clinic visit. Change in temperature is monitored as an indication of decrease systemic inflammation.
Time Frame
From initiation of systemic treatment until 1 month follow up
Title
Changes in size of the Abscess
Description
CT scan of would have been obtained prior to image guided drain placement. Any subsequent CT scans up to 1 month follow up upon discharge will be reviewed to assess changes in size of the abscess. This will be monitored for assessing the effectiveness of intervention.
Time Frame
From patient initial hospitalization up to 1 month follow up
Title
Changes in Drain Output
Description
Drain will have certain output that is recorded daily. Daily drain output will be in unit of ml and will be monitored as a measurement of abscess resolution.
Time Frame
From the drain placement up to 1 month follow up
Title
Duration of drain
Description
The total duration of the drain placement will be recorded in days starting from the day of placement up to drain removal and monitored as a effectiveness of the intervention.
Time Frame
From the drain placement until 1 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Intra-abdominal abscess drained with catheter/drain
Treatment with systemic antibiotics
Able to consent
Exclusion Criteria:
Abscess(es) not amendable for an image guided drain placement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Granchi, MD
Phone
319-356-1339
Email
thomas-granchi@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Ahrens
Phone
319-353-8435
Email
linda-ahrens@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Goffredo, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Keller
Phone
319-335-2123
Email
dsp@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Paolo Goffredo, MD
First Name & Middle Initial & Last Name & Degree
Thomas Granchi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
At this point, there is no IPD sharing plan and not included in the consent process.
Citations:
PubMed Identifier
26155272
Citation
Yoon YI, Hwang S, Cho YJ, Ha TY, Song GW, Jung DH. Therapeutic effect of trans-drain administration of antibiotics in patients showing intractable pancreatic leak-associated pus drainage after pancreaticoduodenectomy. Korean J Hepatobiliary Pancreat Surg. 2015 Feb;19(1):17-24. doi: 10.14701/kjhbps.2015.19.1.17. Epub 2015 Feb 28.
Results Reference
background
PubMed Identifier
22868236
Citation
Sauermann R, Karch R, Kjellsson MC, Feurstein T, Puspok A, Langenberger H, Bohmdorfer M, Jager W, Zeitlinger M. Good penetration of moxifloxacin into human abscesses. Pharmacology. 2012;90(3-4):146-50. doi: 10.1159/000341550. Epub 2012 Aug 3.
Results Reference
background
PubMed Identifier
22441316
Citation
Sauermann R, Feurstein T, Karch R, Kjellsson MC, Jager W, Bohmdorfer M, Puspok A, Langenberger H, Wild T, Winkler S, Zeitlinger M. Abscess penetration of cefpirome: concentrations and simulated pharmacokinetic profiles in pus. Eur J Clin Pharmacol. 2012 Oct;68(10):1419-23. doi: 10.1007/s00228-012-1270-1. Epub 2012 Mar 23.
Results Reference
background
PubMed Identifier
21367377
Citation
Zimmerman LH, Tyburski JG, Glowniak J, Singla R, Lavery T, Nailor M, Stassinopoulus J, Hong K, Barshikar S, Dolman HS, Baylor AE, Wilson RF. Impact of evaluating antibiotic concentrations in abdominal abscesses percutaneously drained. Am J Surg. 2011 Mar;201(3):348-52; discussion 352. doi: 10.1016/j.amjsurg.2010.09.010.
Results Reference
background
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Antibiotic Irrigations for Intra-Abdominal Drains
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