Antibiotic Irrigations for Intra-Abdominal Drains (AID)

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Abscess
• Intervention / Treatment: Drug: Gentamicin Sulfate Inj 20mg/2ml vial for injection; Drug: Clindamycin phosphate 6 mg/1ml for injection; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Thomas Granchi, MD; Phone Number: 319-356-1339; Email: thomas-granchi@uiowa.edu
• Study Contact Backup: Name: Linda Ahrens; Phone Number: 319-353-8435; Email: linda-ahrens@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • The University of Iowa
      • Contact: John Keller; Phone Number: 319-335-2123; Email: dsp@uiowa.edu
      • Principal Investigator: Paolo Goffredo, MD
      • Sub-Investigator: Thomas Granchi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antibiotic Irrigation; The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum	Drug: Gentamicin Sulfate Inj 20mg/2ml vial for injection; 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.; Drug: Clindamycin phosphate 6 mg/1ml for injection; 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.
Placebo Comparator: Normal Saline Irrigation; The drain will be irrigated twice/day with normal saline	Other: Placebo; The placebo group will receive drain irrigation twice/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From initiation of systemic treatment until 1 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From initiation of systemic treatment until 1 month follow up
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.	From initiation of systemic treatment until 1 month follow up
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.	From patient initial hospitalization up to 1 month follow up
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.	From the drain placement up to 1 month follow up
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.	From the drain placement until 1 month follow up

Collaborators and Investigators

• Sponsor: Paolo Goffredo
• Investigators: Principal Investigator: Paolo Goffredo, MD, University of Iowa

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Suppuration; Abscess; Abdominal Abscess; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Gentamicins
• Other Study ID Numbers: 201703759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: At this point, there is no IPD sharing plan and not included in the consent process.

Drug and device information, study documents

• 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