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Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Antibiotics for Perforated Appendicitis

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ClinicalTrials.gov Identifier: NCT03435900
Recruitment Status : Completed
First Posted : February 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Siv Fonnes, Herlev Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Appendicitis Perforated Drug: Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o. Drug: Standard antibiotics intravenously Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Quasi-randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Conventional Antibiotics for Perforated Appendicitis - a Pivotal Quasi-randomized Controlled Trial
Actual Study Start Date : February 14, 2018
Actual Primary Completion Date : July 17, 2018
Actual Study Completion Date : July 17, 2018


Arm Intervention/treatment
Experimental: Intervention group Drug: Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o.
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.

Active Comparator: Control group Drug: Standard antibiotics intravenously
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.




Primary Outcome Measures :
  1. Total length of hospital stay [ Time Frame: From end of surgery until 30-days follow-up ]
    in hours


Secondary Outcome Measures :
  1. Gastrointestinal Quality of Life Index (GIQLI) [ Time Frame: 10 days (±2 days) and 30 days (±3 days) postoperatively ]
    A disease-specific questionnaire validated in Danish is collected at 10 days postoperatively (±2 days) and at 30 days postoperatively (±3 days)

  2. Side effects [ Time Frame: Within 24 hours after surgery and 10 days (±2 days) postoperatively ]
    Number and description. A questionnaire regarding side effects is collected within the first 24 hours after surgery and at 10 days postoperatively (±2 days)

  3. Postoperative complications [ Time Frame: From end of surgery until 30-days follow-up ]
    Number. According to the Clavien-Dindo grading

  4. Surgical site infections requiring surgical drainage [ Time Frame: From end of surgery until 30-days follow-up ]
    It is defined as deep incisional surgical site infection according to Centre for Disease Control and Prevention (CDC)

  5. Intraabdominal abscesses requiring drainage [ Time Frame: From end of surgery until 30-days follow-up ]
    Number. It is defined as an organ/space surgical site infection according to CDC

  6. Readmissions [ Time Frame: From end of surgery until 30-days follow-up ]
    Number. Only readmissions related to the surgery will be registered; e.g. admission and treatment of a non-related condition will not be registered.

  7. Reoperations [ Time Frame: From end of surgery until 30-days follow-up ]
    Number. Only reoperations related to the appendectomy will be registered.

  8. Time to return to normal activities [ Time Frame: From end of surgery until 30-days follow-up ]
    Time period in days. The date is defined at the time point at which the participant could return to normal daily activities.

  9. Period of sick leave "absence from work" [ Time Frame: From end of surgery until 30-days follow-up ]
    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.

  10. Costs [ Time Frame: From end of surgery until 30-days follow-up ]
    The estimated total costs of admission, surgery, possible complications, reoperations etc. in the two treatment groups.

  11. Adverse events [ Time Frame: From end of surgery until 30-days follow-up ]
  12. Microbiological flora and susceptibility [ Time Frame: From end of surgery until 30-days follow-up ]
    Number and type of positive specimens. If participants have a postoperative infectious complication.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual laparoscopic appendectomy
  • Perforated appendicitis (diagnosed during surgery by the surgeon)
  • Negative p-HCG (women)
  • Written informed consent after written and verbal information (preoperatively for the intervention group and postoperatively for the control group)

Exclusion Criteria:

  • Cannot understand, read or speak Danish
  • Previous allergic reaction to fosfomycin, metronidazole, rhGM-CSF, or penicillins e.g. piperacillin or amoxicillin
  • Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy or appendicitis without perforation
  • Other intra-abdominal pathology requiring surgical intervention at the same operation
  • Known renal or hepatic disease or biochemical evidence at the time of admission
  • Known hematologic disease in current medical treatment
  • American Society of Anesthesiologists (ASA) physical status ≥4 (a patient with severe systemic disease that is a constant threat to life)
  • Body weight >110 kg
  • Surgery converted to open appendectomy
  • Anticipated compliance problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435900


Locations
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Denmark
Department of Surgery, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Department of Surgery, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Bispebjerg Hospital

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Responsible Party: Siv Fonnes, MD, PhD-student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03435900     History of Changes
Other Study ID Numbers: HEH-SF-02
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Metronidazole
Fosfomycin
Antibiotics, Antitubercular
Molgramostim
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Antineoplastic Agents