Antimicrobials Local Administration for Intraabdominal Abscesses Treatment

Antimicrobials Local Administration for Intraabdominal Abscesses Treatment: Controlled, Randomized, Open, Parallel Groups, Clinical Trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001376-38-ES

Enrollment

125

Registered

2019-07-04

Start date

2019-08-13

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-abdominal abscesses

Interventions

Pharmaceutical Form: Powder for injection INN or Proposed INN: MEROPENEM CAS Number: 96036-03-2 Other descriptive name: MEROPENEM Concentration unit: mg milligram(s) Concentration type: range Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 / negativization of cultures in the groups under study - Study the development of clinical complications: severe sepsis, kidney failure, others. - To establish if local antibiotic therapy addition reduces the risk of subsequent invasive or surgical procedures; such as: percutaneous drains, endoscopic drainage or open laparotomy. - 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.	—

Measure

Time frame

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 / negativization of cultures in the groups under study - Study the development of clinical complications: severe sepsis, kidney failure, others. - To establish if local antibiotic therapy addition reduces the risk of subsequent invasive or surgical procedures; such as: percutaneous drains, endoscopic drainage or open laparotomy. - 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

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

Spain

Contacts

Public ContactUnidad de Enfermedades Infecciosas

María Dolores Sousa Regueiro

Dolores.Sousa.Regueiro@sergas.es+34981178157

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026