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Acute Appendicitis: Active Observation With and Without Antibiotics

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ClinicalTrials.gov Identifier: NCT03985514
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
This study evaluates if early provision of antibiotics is a superior treatment compared to "traditional wait and see" with regard to symptom relief for suspected acute uncomplicated appendicitis.

Condition or disease Intervention/treatment Phase
Appendicitis Drug: Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3). Other: Active observation Phase 4

Detailed Description:

Recent long-term follow up results of antibiotic treatment of acute appendicitis in unselected populations indicate that approximately 70-80 % of patients respond to antibiotics, while the remaining 20-25% need an operation. Antibiotic treatment was associated with significantly fewer severe and non-severe complications compared to surgery. Therefore, antibiotic treatment can be regarded as safe and effective initial treatment of acute appendicitis based on evidence.

However, it remains to be evaluated to what extent antibiotic treatment is more effective compared to the most conservative application of procedures in the care of patients with acute appendicitis. A well- recognized approach in Sweden is watchful waiting at in-hospital conditions. A certain number of patients with suspected uncomplicated appendicitis will likely recover without any active treatment, but controlled evidence are lacking to what extent such recoveries may occur in the short- and long-term perspective.

The hypothesis is that antibiotic treatment is superior to active observation with regard to symptom relief at suspected acute appendicitis in selected patient groups.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Selected patients with assumed uncomplicated acute appendicitis are allocated to groups "Active observation" or "Antibiotic treatment" in a 1:1 ratio.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimized Treatment for Uncomplicated Acute Appendicitis; Active Observation With or Without Antibiotic Treatment
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Antibiotic treatment
Patients will receive in-hospital intravenous antibiotics (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3). Surgery if no symptom relif occur.
Drug: Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).
Intravenous antibiotic treatment x 3, followed by oral antibiotics for 8-10 Days.
Other Names:
  • Piperacillin/Tazobactam
  • Ciprofloxacin
  • Flagyl

Clinical observation
Patients are followed by in-hospital "Active observation" (watchful waiting) according to clinical routine. Patients are observed until either, recovery and dismissal from hospital, or decision for intervention (surgery) is taken.
Other: Active observation
In-hospital observation without antibiotics




Primary Outcome Measures :
  1. Number of participants with no symptom relief [ Time Frame: 48 hours ]
    No symptom relief and surgery is deemed necessary.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with suspected appendicitis.
  • Age<60 years.
  • C-reactive protein < 60 mg/L.
  • White blod cell Count (leucocytes) < 13 e9 /L.

Exclusion criteria:

  • Pregnant

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): NCT03985514


Contacts
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Contact: Lundholm +46-313421000 ext 4437 kent.lundholm@surgery.gu.se

Locations
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Sweden
Department of surgery, Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 413 45
Contact: Kent Lundholm, MD, prof    46-31-342-1000 ext 4437    kent.lundholm@surgery.gu.se   
Principal Investigator: Kent Lundholm, MD, prof         
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
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Principal Investigator: Kent Lundholm, Professor Göteborg University

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03985514     History of Changes
Other Study ID Numbers: App 2018
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Ciprofloxacin
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Metronidazole
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors
Antiprotozoal Agents
Antiparasitic Agents