Acute Appendicitis: Active Observation With and Without Antibiotics

NCT03985514 | Completed Phase 4

• 1 other identifier: App 2018
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• Number of participants with no symptom relief

  No symptom relief and surgery is deemed necessary.

  48 hours

Study Arms (2)

Antibiotic treatment

ACTIVE COMPARATOR

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).

Clinical observation

OTHER

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

Interventions

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). DRUG

Intravenous antibiotic treatment x 3, followed by oral antibiotics for 8-10 Days.

Also known as: Piperacillin/Tazobactam, Ciprofloxacin, Flagyl

Antibiotic treatment

Active observation OTHER

In-hospital observation without antibiotics

Clinical observation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Department of surgery, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination; Ciprofloxacin; Metronidazole

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones; Drug Combinations; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Kent Lundholm, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Selected patients with assumed uncomplicated acute appendicitis are allocated to groups "Active observation" or "Antibiotic treatment" in a 1:1 ratio.

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: June 13, 2019
• Study Start: May 15, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)