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The Safety and Pharmacokinetics of Intraperitoneal Administration in Patients Undergoing Appendectomy for Uncomplicated Appendicitis

NCT03046758 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-05-29

No results posted yet for this study

Summary

The objective of this trial is to evaluate the safety of the intraperitoneal administration of the combination of fosfomycin, metronidazole, and granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients undergoing surgery for uncomplicated appendicitis. Further, in a sub-trial the aim is to investigate the plasma concentrations of fosfomycin and metronidazole after intraperitoneal administration.

Conditions

  • Appendicitis

Interventions

DRUG

A combination of fosfomycin, metronidazole and GM-CSF i.p.

All drugs will be administered together intraperitoneally at the end of the surgery after the appendix has been removed.

Sponsors & Collaborators

  • Jacob Rosenberg (Sponsor)

    collaborator UNKNOWN

  • Barbara Juliane Holzknecht (Investigator)

    collaborator UNKNOWN

  • Magnus Arpi (Investigator)

    collaborator UNKNOWN

  • Johan Juhl Weisser (Partner, data analysis)

    collaborator UNKNOWN

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Siv Fonnes, MD · Center for Perioperative Optimization, Department of Surgery, Herlev Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2017-12-07
Completion
2017-12-07

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03046758 on ClinicalTrials.gov