A Phase 2 interventional study of Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o. and Standard antibiotics intravenously in Appendicitis Perforated, sponsored by Herlev Hospital. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by Herlev Hospital · Phase 2, Interventional, and Treatment
The objective of this trial is to evaluate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) followed by oral antibiotic for three days is as effective as the current intravenous antibiotic treatment given during and three days after appendectomy for perforated appendicitis. The primary outcome is the total length of hospital stay, defined as the number of hours in hospital after end of operation and until 30-day follow-up.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's enrollment of 13 is below the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Herlev Hospital is the lead sponsor of 201 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o.
Drug: Standard antibiotics intravenously
All drugs will be administered together intraperitoneally at the end of the surgery after the appendix has been removed. Hereafter, the intervention group will receive three days of orally administered antibiotics: 500 mg amoxicillin combined with 125 mg clavulanic acid and 500 mg metronidazole. These doses will be administered three times daily.
4 g piperacillin/500 mg tazobactam and 1 g metronidazole administered intravenously during surgery followed by 4 g piperacillin/500 mg tazobactam and 500 mg metronidazole administered intravenously three times daily for three days.
Total length of hospital stay
in hours
Time frame: From end of surgery until 30-days follow-up
Gastrointestinal Quality of Life Index (GIQLI)
A disease-specific questionnaire validated in Danish is collected at 10 days postoperatively (±2 days) and at 30 days postoperatively (±3 days)
Time frame: 10 days (±2 days) and 30 days (±3 days) postoperatively
Side effects
Number and description. A questionnaire regarding side effects is collected within the first 24 hours after surgery and at 10 days postoperatively (±2 days)
Time frame: Within 24 hours after surgery and 10 days (±2 days) postoperatively
Postoperative complications
Number. According to the Clavien-Dindo grading
Time frame: From end of surgery until 30-days follow-up
Surgical site infections requiring surgical drainage
It is defined as deep incisional surgical site infection according to Centre for Disease Control and Prevention (CDC)
Time frame: From end of surgery until 30-days follow-up
Intraabdominal abscesses requiring drainage
Number. It is defined as an organ/space surgical site infection according to CDC
Time frame: From end of surgery until 30-days follow-up
Readmissions
Number. Only readmissions related to the surgery will be registered; e.g. admission and treatment of a non-related condition will not be registered.
Time frame: From end of surgery until 30-days follow-up
Reoperations
Number. Only reoperations related to the appendectomy will be registered.
Time frame: From end of surgery until 30-days follow-up
Time to return to normal activities
Time period in days. The date is defined at the time point at which the participant could return to normal daily activities.
Time frame: From end of surgery until 30-days follow-up
Period of sick leave "absence from work"
Time periode in days. The parameter is defined as the number of days from the operation to the time point at where the participant returned to work or school.
Time frame: From end of surgery until 30-days follow-up
Costs
The estimated total costs of admission, surgery, possible complications, reoperations etc. in the two treatment groups.
Time frame: From end of surgery until 30-days follow-up
Adverse events
Time frame: From end of surgery until 30-days follow-up
Microbiological flora and susceptibility
Number and type of positive specimens. If participants have a postoperative infectious complication.
Time frame: From end of surgery until 30-days follow-up
Plan to share: Undecided
Ran from Feb 2018 to primary completion in Jul 2018, 5 months.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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