Trials / Completed
CompletedNCT03046758
The Safety and Pharmacokinetics of Intraperitoneal Administration in Patients Undergoing Appendectomy for Uncomplicated Appendicitis
The Safety and Pharmacokinetics of Intraperitoneal Administration of Granulocyte-macrophage Colony-stimulating Factor, Fosfomycin, and Metronidazole in Patients Undergoing Appendectomy for Uncomplicated Appendicitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Herlev Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-02-24
- Primary completion
- 2017-12-07
- Completion
- 2017-12-07
- First posted
- 2017-02-08
- Last updated
- 2019-05-29
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03046758. Inclusion in this directory is not an endorsement.