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NCT03476941 · ClinicalTrials.gov registry record · Phase 2

Antibiotic Irrigations for Intra-Abdominal Drains

A Phase 2 study of Abdominal Abscess, sponsored by Paolo Goffredo.

Recruiting
Registry status
Phase 2
Development phase
50
Enrollment target
1
Study location

NCT03476941: Recruiting Phase 2 study of Abdominal Abscess, sponsored by Paolo Goffredo.

NCT03476941 is a Phase 2 study of Abdominal Abscess that is actively recruiting participants, run by Paolo Goffredo. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03476941, a Phase 2 study of Abdominal Abscess, is actively recruiting participants, sponsored by Paolo Goffredo.

RECRUITING
Registry status
Phase 2
Development phase
50 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Gentamicin Sulfate Inj 20mg/2ml vial for injection
  • DRUG Clindamycin phosphate 6 mg/1ml for injection

Study Locations (1)

Iowa

  • The University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2019-04-01
Est. Completion 2021-09-01
Phase Phase 2
Paolo Goffredo

1 total trials

What NCT03476941 shows while recruiting

NCT03476941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 1 condition, with Abdominal Abscess appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03476941 reports a single indexed study location in Iowa.

Frequently Asked Questions

What is clinical trial NCT03476941 about?

NCT03476941 is a clinical study titled "Antibiotic Irrigations for Intra-Abdominal Drains". 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. Th...

What is the current status of trial NCT03476941?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2019-04-01. Estimated completion is 2021-09-01.

What conditions does trial NCT03476941 study?

This clinical trial studies the following conditions: Abdominal Abscess.

What interventions are being tested in trial NCT03476941?

The interventions under investigation include: Placebo (OTHER), Gentamicin Sulfate Inj 20mg/2ml vial for injection (DRUG), Clindamycin phosphate 6 mg/1ml for injection (DRUG).

Who is sponsoring clinical trial NCT03476941?

This trial is sponsored by Paolo Goffredo, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03476941 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03476941's enrollment target sits among peer trials

50 1195th of 2000 higher than 741 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03476941, the US trial registry maintained by the National Library of Medicine. NCT03476941 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.