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New treatment option for Complicated Acute Appendicitis
Official title The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)
ClinicalTrials.gov ID: NCT03688295
What this study is testing
What is Antibiotics?
Antibiotics is an investigational medicine, being studied as a potential treatment for complicated acute appendicitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Around 30% of appendectomies are performed for complicated acute appendicitis (CAA, i.e. cases with perforated appendicitis, extraluminal fecaliths, abscesses, or local or generalized peritonitis).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- CAA suspected pre-operatively through a Saint-Antoine score ≤3 and confirmed peroperatively by the presence of a perforated appendicitis...
- Laparoscopic appendectomy.
- Aged 18 or over
- Written, informed consent
You likely can't join if
- Pre-operative exclusion criteria:
- Patients with cardiac valvulopathy
- Immunodepressed patients
- Diabetic patients
- Patients who have received an antibiotic treatment within 3 months before the surgery (and having a potential impact on the intestinal flora)
- Related to the diagnosis: other diseases (Crohn's disease, ulcerative colitis, treatment with an immunosuppressive therapy).
See the full eligibility criteria
- CAA suspected pre-operatively through a Saint-Antoine score ≤3 and confirmed peroperatively by the presence of a perforated appendicitis, extraluminal fecaliths, abscesses and/or localized peritonitis (pus in one or two...
- Laparoscopic appendectomy.
- Aged 18 or over
- Written, informed consent
- Pre-operative exclusion criteria:
- Patients with cardiac valvulopathy
- Immunodepressed patients
- Diabetic patients
- Patients who have received an antibiotic treatment within 3 months before the surgery (and having a potential impact on the intestinal flora)
- Related to the diagnosis: other diseases (Crohn's disease, ulcerative colitis, treatment with an immunosuppressive therapy).
- Related to the severity of the appendicitis:
- A Saint-Antoine score of 4 or 5 (non-complicated acute appendicitis)
- Severe sepsis, septic shock, generalized peritonitis
- Related to the treatment:
- A decision to perform open appendectomy.
- Patients who received an adaptive dose of Levofloxacine 250 mg/24H instead of 500 mg/24H in pre-operative or in per-operative (notably for patients with creatinine clearance ≤ 50 ml/min)
- allergy to metronidazole or to one of the excipient
- Contra-indication to the use of ceftriaxone (hypersensibility to the active substance, to another cephalosporin, to the excipient of the used speciality), history of severe hypersesibility (as anaphylactic shock)...
- Contra-indication to the use of levofloxacin, hypersensibility to levofloxacin, to another quinolone or to the excipient of one of the use speciality, hypersensibility to levofloxacine ou any other quinolone or to any...
- Related to the patient
- Living at more than one hour from an hospital
- Patient who has no relative or other third person who could be present at home and provide assistance in case of any problem for the discharged patient
- Per-operative exclusion criteria (related to the severity of appendicitis):
- Non-complicated forms (catarrhal appendicitis or the absence of extraluminal fecaliths, abscess or peritonitis).
- Generalized purulent or stercoral peritonitis (the presence of pus or faeces in more than two quadrants of the abdomen). In order to assess the reproducibility of the inclusion criteria in the various centres and to...
- Pregnancy or breastfeeding.
- Patients under guardianship.
- Patients unable to provide informed consent.
- Patient lacking social security coverage
- Allergy to metronidazole
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.