Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty - Full Text View

Purpose

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

Condition	Intervention	Phase
Total Hip and Knee Arthroplasties	Drug: Teicoplanin Drug: β-lactams or ciprofloxacin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Efficacy of Teicoplanin for the Prevention of Surgical Site Infections After Total Hip or Knee Arthroplasty: A Prospective, Open-Label Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Athens:

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. [ Time Frame: Two years ] [ Designated as safety issue: No ]

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. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment:	616
Study Start Date:	August 2004
Study Completion Date:	December 2007
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty.	Drug: 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 Other Name: Glycopeptide
Active Comparator: 2 Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty.	Drug: β-lactams or ciprofloxacin Multiple doses for up to six consecutive days Other Name: Cephalosporins or ciprofloxacin or penicillincs

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719056

Locations

Greece
2nd Department of Orthopedics, KAT Hospital
Maroussi, Athens, Greece, 14527
3rd Department of Orthopedics, KAT Hospital
Maroussi, Athens, Greece, 14527
4th Department of Orthopedics, KAT Hospital
Maroussi, Athens, Greece, 14527

Sponsors and Collaborators

University of Athens

KAT Hospital of Athens

Investigators

Study Chair:	Helen Giamarellou, MD, PhD	4th Department of Internal Medicine, University of Athens, Medical School, Greece
Principal Investigator:	Amyntas Varvaroussis, MD	3rd Department of Orthopedics, KAT Hospital, Maroussi, Greece
Principal Investigator:	Panagiotis Papadelis, MD	2nd Department of Orthopedics, KAT Hospital, Maroussi, Greece
Principal Investigator:	Vassilios Nikolaidis, MD	4th Department of Orthopedics, KAT Hospital, Maroussi, Greece
Study Director:	Antonios Papadopoulos, MD, PhD	4th Department of Internal Medicine, University of Athens, Medical School, Greece

More Information

Publications:

Soriano A, Popescu D, García S, Bori G, Martínez 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.

Wilson AP, Grüneberg RN, Neu H. Dosage recommendations for teicoplanin. J Antimicrob Chemother. 1993 Dec;32(6):792-6. Review. No abstract available.

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.

Responsible Party:	University of Athens, Medical School, Greece
ClinicalTrials.gov Identifier:	NCT00719056 History of Changes
Other Study ID Numbers:	TEICO01
Study First Received:	July 14, 2008
Last Updated:	July 18, 2008
Health Authority:	Greece: National Organization of Medicines

Keywords provided by University of Athens:

teicoplanin
prophylaxis
arthroplasty
surgical site infections

Additional relevant MeSH terms:

Ciprofloxacin
Teicoplanin
Cephalosporins
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013