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Trial record 38 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis (APPACII)

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ClinicalTrials.gov Identifier: NCT03236961
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborators:
Oulu University Hospital
Tampere University Hospital
Kuopio University Hospital
Mikkeli Central Hospital
Lapland Central Hospital
Jyväskylä Central Hospital
Satakunta Central Hospital
Seinajoki Central Hospital
Information provided by (Responsible Party):
Paulina Salminen, Turku University Hospital

Brief Summary:

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings.

The aim of this randomized prospective study is to optimize antibiotic therapy for uncomplicated acute appendicitis by comparing different antibiotic regimens; intravenous antibiotic (ertapenem) followed by per oral antibiotic (levofloxacin and metronidazole) with only per oral antibiotics (moxifloxacin). Before randomization, the diagnosis of acute uncomplicated appendicitis is confirmed with a CT scan.

The hypothesis is that broad-spectrum intravenous antibiotics requiring additional hospital resources are not necessary for the treatment of uncomplicated acute appendicitis and that per oral mono therapy is non-inferior to the combination of intravenous and per oral antibiotic therapy.


Condition or disease Intervention/treatment Phase
Acute Appendicitis Drug: Ertapenem Drug: Moxifloxacin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 552 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open-label
Primary Purpose: Treatment
Official Title: Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis: a Prospective Randomised Multicenter Study (The APPAC II Study)
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous & per oral antibiotics
Ertapenem 1 g x 1 for two days i.v. followed by p.o. levofloxacin 500 mg x 1 and metronidazole 500 mg x 3 for 5 days, duration of treatment one week.
Drug: Ertapenem
I.v. ertapenem 1 g for 2 days followed by p.o. levofloxacin 500 mg x1 and metronidazole 500 mg x 3 for 5 days
Other Names:
  • Levofloxacin
  • Metronidazole

Active Comparator: Per oral antibiotics
Moxifloxacin 400 mg x 1 foe seven days, duration of treatment one week.
Drug: Moxifloxacin
P.o. moxifloxacin 400 mg x1 for 7 days




Primary Outcome Measures :
  1. Treatment success [ Time Frame: 1 year ]
    The resolution of acute uncomplicated appendicitis with allocated antibiotic treatment. Treatment success is defined as discharge from the hospital without the need for surgical intervention after the primary hospitalisation and no recurrent appendicitis during one-year follow-up.


Secondary Outcome Measures :
  1. Late recurrence of appendicitis after antibiotic treatment [ Time Frame: 1 year ]
    Recurring appendicitis after primary treatment considered successful, thus recurrence after one year

  2. Duration of hospital stay [ Time Frame: 1 month ]
    Hospital stay

  3. Post-intervention complications [ Time Frame: 10 years ]
    Complications according to the Clavien-Dindo classification

  4. VAS pain score (visual analogue score) [ Time Frame: 10 years ]
    Pain as described with a scale from 0-10

  5. Sick leave [ Time Frame: 1 month ]
    Duration of sick leave

  6. Treatment costs [ Time Frame: 1 year ]
    Treatment costs including hospital stay costs, medicinal costs, imaging costs, costs to treat possible complications, operative costs



Information from the National Library of Medicine

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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:

  • Age 18-60 years
  • CT confirmed uncomplicated acute appendicitis
  • Ability to give consent to participate in the study

Exclusion Criteria:

  • Age under 18 years or over 60 years
  • Pregnancy or lactation
  • Allergy to contrast media or iodine
  • Allergy or contraindication to antibiotic therapy
  • Renal insufficiency
  • Metformin medication
  • Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medication)
  • CT confirmed complicated acute appendicitis
  • Inability to co-operate and give informed consent

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): NCT03236961


Contacts
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Contact: Paulina Salminen, MD, PhD +358407181896 paulina.salminen@tyks.fi
Contact: Juha Grönroos, MD, PhD +358405888580 juha.gronroos@tyks.fi

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland
Contact: Paulina Salminen       paulina.salminen@tyks.fi   
Principal Investigator: Paulina Salminen, MD, PhD         
Sub-Investigator: Juha Grönroos, MD, PhD         
Sub-Investigator: Suvi Sippola, MD         
Sponsors and Collaborators
Turku University Hospital
Oulu University Hospital
Tampere University Hospital
Kuopio University Hospital
Mikkeli Central Hospital
Lapland Central Hospital
Jyväskylä Central Hospital
Satakunta Central Hospital
Seinajoki Central Hospital
Investigators
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Principal Investigator: Paulina Salminen, MD, PhD Turku University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paulina Salminen, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03236961     History of Changes
Other Study ID Numbers: APPAC II
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
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
Keywords provided by Paulina Salminen, Turku University Hospital:
uncomplicated acute appendicitis
complicated acute appendicitis
antibiotic therapy
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Antitubercular Agents
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Moxifloxacin
Metronidazole
Levofloxacin
Ofloxacin
Ertapenem