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Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

Primary Purpose

Total Hip and Knee Arthroplasties

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Teicoplanin
β-lactams or ciprofloxacin
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Total Hip and Knee Arthroplasties focused on measuring teicoplanin, prophylaxis, arthroplasty, surgical site infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted for total hip arthroplasty
  • Patients admitted for total knee arthroplasty

Exclusion Criteria:

  • Revision arthroplasty
  • History of any infection within the preceding two months
  • History of an operation in the same hip or knee for other causes
  • Known history of allergy to the studied drug
  • Pregnancy or lactation
  • Any antibiotic therapy in the week before operation.

Sites / Locations

  • 2nd Department of Orthopedics, KAT Hospital
  • 3rd Department of Orthopedics, KAT Hospital
  • 4th Department of Orthopedics, KAT Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.

Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty.

Outcomes

Primary Outcome Measures

To compare the efficacy of single dose teicoplanin compared with comparator agents in the prevention of surgical site infections after total hip or knee arthroplasty.

Secondary Outcome Measures

To compare the efficacy of single dose teicoplanin compared with comparator agents in the separate prevention of superficial or deep surgical site infections after total hip or knee arthroplasty.

Full Information

First Posted
July 14, 2008
Last Updated
July 18, 2008
Sponsor
University of Athens
Collaborators
KAT Hospital of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT00719056
Brief Title
Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty
Official Title
Efficacy of Teicoplanin for the Prevention of Surgical Site Infections After Total Hip or Knee Arthroplasty: A Prospective, Open-Label Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Athens
Collaborators
KAT Hospital of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with teicoplanin or with other antibiotics. The study is aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections
Detailed Description
This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with a single dose of teicoplanin or with multiple doses of other antibiotics according to the habits of the attending physicians aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip and Knee Arthroplasties
Keywords
teicoplanin, prophylaxis, arthroplasty, surgical site infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
616 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty.
Intervention Type
Drug
Intervention Name(s)
Teicoplanin
Other Intervention Name(s)
Glycopeptide
Intervention Description
The selected dose was 10mg/kg and it was given intravenously by a catheter inserted under aseptic conditions in a forearm vein within 15 minutes; it was diluted in one 5% glucose solution of a 50 ml final volume
Intervention Type
Drug
Intervention Name(s)
β-lactams or ciprofloxacin
Other Intervention Name(s)
Cephalosporins or ciprofloxacin or penicillincs
Intervention Description
Multiple doses for up to six consecutive days
Primary Outcome Measure Information:
Title
To compare the efficacy of single dose teicoplanin compared with comparator agents in the prevention of surgical site infections after total hip or knee arthroplasty.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
To compare the efficacy of single dose teicoplanin compared with comparator agents in the separate prevention of superficial or deep surgical site infections after total hip or knee arthroplasty.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted for total hip arthroplasty Patients admitted for total knee arthroplasty Exclusion Criteria: Revision arthroplasty History of any infection within the preceding two months History of an operation in the same hip or knee for other causes Known history of allergy to the studied drug Pregnancy or lactation Any antibiotic therapy in the week before operation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Giamarellou, MD, PhD
Organizational Affiliation
4th Department of Internal Medicine, University of Athens, Medical School, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amyntas Varvaroussis, MD
Organizational Affiliation
3rd Department of Orthopedics, KAT Hospital, Maroussi, Greece
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Panagiotis Papadelis, MD
Organizational Affiliation
2nd Department of Orthopedics, KAT Hospital, Maroussi, Greece
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vassilios Nikolaidis, MD
Organizational Affiliation
4th Department of Orthopedics, KAT Hospital, Maroussi, Greece
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonios Papadopoulos, MD, PhD
Organizational Affiliation
4th Department of Internal Medicine, University of Athens, Medical School, Greece
Official's Role
Study Director
Facility Information:
Facility Name
2nd Department of Orthopedics, KAT Hospital
City
Maroussi
State/Province
Athens
ZIP/Postal Code
14527
Country
Greece
Facility Name
3rd Department of Orthopedics, KAT Hospital
City
Maroussi
State/Province
Athens
ZIP/Postal Code
14527
Country
Greece
Facility Name
4th Department of Orthopedics, KAT Hospital
City
Maroussi
State/Province
Athens
ZIP/Postal Code
14527
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
16424973
Citation
Soriano A, Popescu D, Garcia S, Bori G, Martinez JA, Balasso V, Marco F, Almela M, Mensa J. Usefulness of teicoplanin for preventing methicillin-resistant Staphylococcus aureus infections in orthopedic surgery. Eur J Clin Microbiol Infect Dis. 2006 Jan;25(1):35-8. doi: 10.1007/s10096-005-0073-z.
Results Reference
background
PubMed Identifier
8144419
Citation
Wilson AP, Gruneberg RN, Neu H. Dosage recommendations for teicoplanin. J Antimicrob Chemother. 1993 Dec;32(6):792-6. doi: 10.1093/jac/32.6.792. No abstract available.
Results Reference
background
PubMed Identifier
9833102
Citation
Nehrer S, Thalhammer F, Schwameis E, Breyer S, Kotz R. Teicoplanin in the prevention of infection in total hip replacement. Arch Orthop Trauma Surg. 1998;118(1-2):32-6. doi: 10.1007/s004020050306.
Results Reference
background

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Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

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