Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jacob Rosenberg (Sponsor) | UNKNOWN |
| Barbara Juliane Holzknecht (Investigator) | UNKNOWN |
| Magnus Arpi (Investigator) | UNKNOWN |
| Johan Juhl Weisser (Partner, data analysis) |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A combination of fosfomycin, metronidazole and GM-CSF i.p. | Drug | All drugs will be administered together intraperitoneally at the end of the surgery after the appendix has been removed. |
| Measure | Description | Time Frame |
|---|---|---|
| Main trial (14 patients): Drop of white blood cell counts | The safety of intraperitoneal administration is evaluated through the white blood cell counts 4 hours (± 30 minutes) postoperatively. A toxic effect is defined by a drop below the lower reference range. | 4 hours (± 30 minutes) |
| Sub-trial (8 patients): The pharmacokinetics of fosfomycin. | The plasma concentrations of fosfomycin over time are measured with high-performance liquid chromatography mass spectrometry (HPLC-MS) until 24 hours after surgery ±4 hours. | Until 24 hours after surgery ±4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Main trial (14 patients): Biochemical markers | A standard panel of blood samples (e.g. white blood cell differential count, inflammation marker C-reactive protein (CRP), kidney function tests, liver function tests, and electrolytes) are analysed at admission (baseline) and 4 hours ±30 minutes postoperatively, these markers are compared. | 4 hours ±30 minutes postoperatively. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Siv Fonnes, MD | Center for Perioperative Optimization, Department of Surgery, Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Herlev Hospital | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31040341 | Result | Fonnes S, Holzknecht BJ, Arpi M, Rosenberg J. Intraperitoneal administration of fosfomycin, metronidazole, and granulocyte-macrophage colony-stimulating factor in patients undergoing appendectomy is safe: a phase II clinical trial. Sci Rep. 2019 Apr 30;9(1):6727. doi: 10.1038/s41598-019-43151-4. |
| Label | URL |
|---|---|
| Link to the article regarding the safety (open access) | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| Main trial (14 patients): Blood pressure | Blood pressure in mmHg is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered). | Until 12 hours ±30 minutes. |
| Main trial (14 patients): Pulse | Pulse in beats per minute is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered). | Until 12 hours ±30 minutes. |
| Main trial (14 patients): Frequency of respiration | Frequency of respiration in breaths per minute is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered). | Until 12 hours ±30 minutes. |
| Main trial (14 patients): Peripheral saturation | Peripheral saturation of oxygen in percent is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered). | Until 12 hours ±30 minutes. |
| Main trial (14 patients): Temperature | Temperature in degrees Celsius is measured perioperatively (baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered) and postoperatively (4 and 12 hours ±30 minutes after the trial treatment has been administered). | Until 12 hours ±30 minutes. |
| Main trial (14 patients): Length of stay. | Length of stay in hours postoperatively (minimum length of stay: 12 hours but information on length of stay is collected until 30 days postoperatively). | Until 30 days postoperatively. |
| Main trial (14 patients): Length of stay. | Length of stay in hours postoperatively (minimum 12 hours). | Until 30 days postoperatively. |
| Main trial (14 patients): Side effects | Side effects are evaluated through an objective examination and questions about changes 12 hours ±30 minutes and 10 days postoperatively ±1 day. | 10 days postoperatively ±1 day. |
| Main trial (14 patients): Adverse events | Adverse events are registered from the surgery until 30 days postoperatively through medical records and contact with the participant by telephone. | Until 30 days postoperatively. |
| Sub-trial (8 patients): The pharmacokinetics of metronidazole. | The plasma concentrations of metronidazole over time are measured with HPLC-MS until 24 hours after surgery ±4 hours. | Until 24 hours after surgery ±4 hours. |
| Sub-trial (8 patients): Microbiological flora and susceptibility | The microbiological flora and susceptibility of specimens collected during the surgery from the abdominal excess fluid and/or swab from the appendices are investigated. | Until 30 days postoperatively. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |