A Phase 2 interventional study of Gentamicin Sulfate Inj 20mg/2ml vial for injection and Clindamycin phosphate 6 mg/1ml for injection in Abdominal Abscess, sponsored by University of Iowa. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Iowa · Phase 2, Interventional, and Treatment
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.
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.
31 studies on the registry are indexed under Abdominal Abscess; 5 are open to participants now.
This study's enrollment of 2 is below the median of 105 across 24 interventional studies indexed under Abdominal Abscess.
Browse Abdominal Abscess studies →University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Drug: Clindamycin phosphate 6 mg/1ml for injection
The drain will be irrigated twice/day with normal saline
Other: Placebo
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 page: Clindamycin phosphate
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.
The placebo group will receive drain irrigation twice/day
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.
Time frame: From initiation of systemic treatment until 1 month follow up
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.
Time frame: From initiation of systemic treatment until 1 month follow up
Maximum Temperature From Initiation of Systemic Treatment Until 1 Month Follow up
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
| Milestone | Antibiotic Irrigation | Normal Saline Irrigation |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
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.
| days | Antibiotic Irrigation | Normal Saline Irrigation |
|---|---|---|
| Duration of Systemic Antibiotics: | 19 | 26 |
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.
| 10^9 cells per liter | Antibiotic Irrigation | Normal Saline Irrigation |
|---|---|---|
| White Blood Count | 17.5 | — |
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.
| °C | Antibiotic Irrigation | Normal Saline Irrigation |
|---|---|---|
| Maximum Temperature From Initiation of Systemic Treatment Until 1 Month Follow up | 39.7 | — |
Collected over - Clinical outcomes may be collected up to 30 days post discharge. - Subject participation in the study will last approximately 30 days with no additional follow up visits as part of the involvement in this study. - Data from clinical visits and/or follow up within the 30 days will be collected as part of the research.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antibiotic Irrigation | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Normal Saline Irrigation | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
no description was possible as only 1 subject was enroll in each arm
| Age, Categorical(Participants) | Antibiotic Irrigation | Normal Saline Irrigation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Antibiotic Irrigation | Normal Saline Irrigation | Total |
|---|---|---|---|
| Median | 40 (40 to 40) | 47 (47 to 47) | 43.5 (40 to 47) |
| Sex: Female, Male(Participants) | Antibiotic Irrigation | Normal Saline Irrigation | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Antibiotic Irrigation | Normal Saline Irrigation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Antibiotic Irrigation | Normal Saline Irrigation | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — At this point, there is no IPD sharing plan and not included in the consent process.
Ran from Apr 2019 to primary completion in Oct 2020, 18 months.
Results were first posted in Sep 2026, 5 years 10 months after primary completion.
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Studies of the drug tested here: Clindamycin phosphate