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Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

NCT ID: NCT00719056

Last Updated: 2008-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

616 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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

Conditions

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Total Hip and Knee Arthroplasties

Keywords

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teicoplanin prophylaxis arthroplasty surgical site infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Teicoplanin

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

β-lactams or ciprofloxacin

Intervention Type DRUG

Multiple doses for up to six consecutive days

Interventions

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Teicoplanin

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

β-lactams or ciprofloxacin

Multiple doses for up to six consecutive days

Intervention Type DRUG

Other Intervention Names

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Glycopeptide Cephalosporins or ciprofloxacin or penicillincs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KAT Hospital of Athens

UNKNOWN

Sponsor Role collaborator

University of Athens

OTHER

Sponsor Role lead

Responsible Party

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University of Athens, Medical School, Greece

Principal Investigators

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Helen Giamarellou, MD, PhD

Role: STUDY_CHAIR

4th Department of Internal Medicine, University of Athens, Medical School, Greece

Amyntas Varvaroussis, MD

Role: PRINCIPAL_INVESTIGATOR

3rd Department of Orthopedics, KAT Hospital, Maroussi, Greece

Panagiotis Papadelis, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Department of Orthopedics, KAT Hospital, Maroussi, Greece

Vassilios Nikolaidis, MD

Role: PRINCIPAL_INVESTIGATOR

4th Department of Orthopedics, KAT Hospital, Maroussi, Greece

Antonios Papadopoulos, MD, PhD

Role: STUDY_DIRECTOR

4th Department of Internal Medicine, University of Athens, Medical School, Greece

Locations

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2nd Department of Orthopedics, KAT Hospital

Marousi, Athens, Greece

Site Status

3rd Department of Orthopedics, KAT Hospital

Marousi, Athens, Greece

Site Status

4th Department of Orthopedics, KAT Hospital

Marousi, Athens, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 16424973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8144419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9833102 (View on PubMed)

Other Identifiers

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TEICO01

Identifier Type: -

Identifier Source: org_study_id