Antimicrobials Local Administration for Intraabdominal Abscesses Treatment

Phase 1

• Conditions: Intra-abdominal abscesses; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-001376-38-ES
• Lead Sponsor: María Dolores Sousa Regueiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

- to be 18 years old or more
- Intra-abdominal abscesses of any etiology that require
drainage catheter placement
- Signature of the specific Informed Consent of the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Need for early open surgery (laparotomy)
- Patients with systemic embolisms or multiple foci of infection
- Impossibility of performing antibiotic sealing for at least 3-4
hours continuously if an antibiotic with activity is used
time-dependent
- Pregnant women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the clinical response of the addition of local antibiotic therapy to the standard treatment of intra-abdominal abscesses;Secondary Objective: - Determine the time until microbiological eradication<br>/ negativization of cultures in the groups under study<br>- Study the development of clinical complications: severe sepsis,<br>kidney failure, others.<br>- To establish if local antibiotic therapy addition reduces the risk of<br>subsequent invasive or surgical procedures; such as:<br>percutaneous drains, endoscopic drainage or open laparotomy.<br>- Assess systemic antimicrobial use by episode;Primary end point(s): Better clinical response with the addition of local antibiotic therapy to the standard treatment of intra-abdominal abscesses.;Timepoint(s) of evaluation of this end point: An evaluation of the end of treatment will be carried out and 1 month after the last administration of the antibiotic.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None