Total Hip and Knee ArthroplastiesPhase 4NCT00719056
Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty
A Phase 4 study testing Teicoplanin and β-lactams or ciprofloxacin in people with Total Hip and Knee Arthroplasties, run by University of Athens at 3 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip and Knee Arthroplasties
- What is being tested?
- Teicoplanin and β-lactams or ciprofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 3 sitesGreece
- Study dates
- Aug 2004to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted for total hip arthroplasty
- Patients admitted for total knee arthroplasty
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
2nd Department of Orthopedics, KAT Hospital
Marousi, Athens, 14527
3rd Department of Orthopedics, KAT Hospital
Marousi, Athens, 14527
4th Department of Orthopedics, KAT Hospital
Marousi, Athens, 14527
About this study
Official title: Efficacy of Teicoplanin for the Prevention of Surgical Site Infections After Total Hip or Knee Arthroplasty: A Prospective, Open-Label Randomized Study
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
Read the 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
- Conditions
- Total Hip and Knee Arthroplasties
- Being tested
- Teicoplanin, β-lactams or ciprofloxacin
- Keywords
- teicoplanin, prophylaxis, arthroplasty, surgical site infections
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeicoplaninDrug
Also called Glycopeptide
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
β-lactams or ciprofloxacinDrug
Also called Cephalosporins or ciprofloxacin or penicillincs
Multiple doses for up to six consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Surgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty. Receives: Drug: Teicoplanin |
| 2 | Active comparator | Surgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty. Receives: Drug: β-lactams or ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (1)
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startAug 2004
- Primary completionDec 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Hip and Knee ArthroplastiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- KAT General Hospital
- Investigators
- Helen Giamarellou, MD, PhD, Study chair, 4th Department of Internal Medicine, University of Athens, Medical School, GreeceAmyntas Varvaroussis, MD, Principal investigator, 3rd Department of Orthopedics, KAT Hospital, Maroussi, GreecePanagiotis Papadelis, MD, Principal investigator, 2nd Department of Orthopedics, KAT Hospital, Maroussi, GreeceVassilios Nikolaidis, MD, Principal investigator, 4th Department of Orthopedics, KAT Hospital, Maroussi, GreeceAntonios Papadopoulos, MD, PhD, Study director, 4th Department of Internal Medicine, University of Athens, Medical School, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719056
- Sponsor's protocol ID
- TEICO01
- Status last verified
- Jul 2008
- First submitted
- 14 Jul 2008
- Last updated
- 21 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16424973Wilson 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.
PubMed 8144419Nehrer 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.
PubMed 9833102
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Teicoplanin for the Prevention of Surgical Site Infections After Total Hip or Knee Arthroplasty: A Prospective, Open-Label Randomized Study
- ClinicalTrials.gov ID
- NCT00719056
- Acronym / sponsor ID
- TEICO01
- Conditions
- Total Hip and Knee Arthroplasties
- Keywords
- teicoplanin, prophylaxis, arthroplasty, surgical site infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- KAT General Hospital
- Study start
- Aug 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TeicoplaninSurgical chemoprophylaxis of one dose of teicoplanin upon introduction of anesthesia for total hip or knee arthroplasty. |
| 2 | Active comparator | Drug: β-lactams or ciprofloxacinSurgical chemoprophylaxis with multiple dose of other antimicrobials for up to six consecutive days for total hip or knee arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted for total hip arthroplasty
- Patients admitted for total knee arthroplasty
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeicoplaninAlso: GlycopeptideThe 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 | Drug | 1 |
| β-lactams or ciprofloxacinAlso: Cephalosporins or ciprofloxacin or penicillincsMultiple doses for up to six consecutive days | Drug | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2008.
- Background: PubMed 16424973Soriano 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.
- Background: PubMed 8144419Wilson 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.
- Background: PubMed 9833102Nehrer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Giamarellou, MD, PhD study chair
4th Department of Internal Medicine, University of Athens, Medical School, Greece
Amyntas Varvaroussis, MD principal investigator
3rd Department of Orthopedics, KAT Hospital, Maroussi, Greece
Panagiotis Papadelis, MD principal investigator
2nd Department of Orthopedics, KAT Hospital, Maroussi, Greece
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teicoplanin and β-lactams or ciprofloxacin in people with Total Hip and Knee Arthroplasties, run by University of Athens at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719056, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2008; AzTrials last refreshed its copy on 6 Nov 2026.