Catheterization, Central VenousPhase 4NCT00515151
Prevention of Catheter-Associated Infection With the Skin Disinfectant Octenidine Dihydrochloride
A Phase 4 study testing 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol and 74% Ethanol with 10% 2-propanol in people with Catheterization, Central Venous and Catheter-Associated Infections, run by University Hospital Freiburg at 2 sites in 2 countries.
Trial summary
Health-care-acquired infections are of tremendous importance for patients, especially catheter-associated infections. More than 40% of all bloodstream infections are associated with central venous catheters (CVC; catheters which are inserted into a large vein near the heart). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Central Venous, Catheter-Associated Infections, Bacterial Infections
- What is being tested?
- 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol and 74% Ethanol with 10% 2-propanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2002to Apr 2005
- 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 >18 years
- Medical indication for CVC with a planned duration of minimum 5 days
- Patient´s (or relative´s if applicable) written informed consent
Who cannot join
- Known sensitisation against the proposed antiseptics
- Tunneled or implanted CVCs (e.g. Hickman Catheter)
- Administration of antimicrobial drugs for therapy (not prophylaxis) less than one week prior to catheterization
- Pre-existing bloodstream infection (i.e., fever and/or other signs of infection)
- Positive blood culture
- Terminal patients with limited therapy options
Show all 9Show fewer
- Patients with burns
- Patients participating in a clinical trial on other antiseptics within a period of four weeks prior to inclusion date
- Patients with missing written consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg
Freiburg im Breisgau
Switzerland1 site
Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel
Basel
About this study
Official title: Skin Disinfection With Octenidine Dihydrochloride for the Prevention of Catheter-Associated Infections - A Double-Blind, Randomized, Controlled Trial
Health-care-acquired infections are of tremendous importance for patients, especially catheter-associated infections. More than 40% of all bloodstream infections are associated with central venous catheters (CVC; catheters which are inserted into a large vein near the heart). Of all patients that acquire such an infection 1% to 5% die as a result from it. The insertion site is the main source of contamination and infection. In general, bacteria of the skin are the cause of infection, especially in short-term CVCs (10-14 days). Therefore it is necessary to efficiently disinfect the skin for the preparation and care of CVC insertion sites. Several substances are used for disinfection. Alcohol-based disinfectants are mainly used in Central Europe, other preparations contain povidine-iodine or chlorhexidine. Alcoholic disinfectants have a rapid initial effect, chlorhexidine shows an additional remanent (longer lasting) effect. A further substance, octenidine dihydrochloride, also demonstrated a remanent effect in a pilot study with neurosurgical patients. The purpose of our study is to compare an alcohol-based disinfectant containing octenidine dihydrochloride with a pure alcoholic disinfectant regarding efficacy and tolerability in patients receiving a CVC for a minimum of 5 days.
Read the detailed description
Catheter-associated infections are one of the most eminent healthcare acquired infections. More than 40% of all bloodstream infections are associated with a central venous catheter (CVC)and between 1% and 5% of the affected patients die as a direct consequence of this infection. The most important microorganisms are gram-positive cocci (S. aureus, S. epidermidis). In intensive care units gram-negative microorganisms such as pseudomonas, acinetobacter and candida spp. are more frequent. The insertion site is the main source of contamination and infection in short-term CVCs (10-14 days. In this case the infection is caused by migration of microorganisms along the outside of the catheter. Contamination of the hub due to frequent manipulation is usually the source of infection in long-term CVCs. In this case the infection occurs intraluminally. An effective skin disinfection is the main measure of prevention before insertion of a CVC. The aim of this measure is the elimination of transient and the reduction of resident microorganisms around the insertion site. To achieve this, disinfectants on the basis of alcohol, povidone-iodine or chlorhexidine are applied. Alcohol-based disinfectants are preferred in Central Europe because of their rapid initial effect and broad microbiological spectrum. Chlorhexidine and povidone-Iodine in contrast to alcoholic disinfectants have a remanent effect which reduces regrowth of microorganisms beyond the immediate initial effect. To which extent remanent substances reduce colonization of the CVC extraluminally or the CVC-tip is still being disputed. In an earlier clinical trial a residual or remanent effect of 0.1% octenidine combined with propanol in microbial skin decontamination over a 24h period was shown in neurosurgical patients receiving a central line (CVC or peripherally inserted central catheter). The objective of this study is therefore to evaluate further the preventive impact and tolerability of a commercially available, alcohol-based antiseptic solution containing octenidine for the preparation and care of CVC insertion sites in a clinical setting in comparison with the results given by an alcoholic solution alone.
- Conditions
- Catheterization, Central Venous, Catheter-Associated Infections, Bacterial Infections, Bacteremia
- Being tested
- 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol, 74% Ethanol with 10% 2-propanol
- Keywords
- Bloodstream Infection, Bacteremia, Central Venous Catheter, Alcohol, Disinfection, Octenidine Dihydrochloride
- Medical subject headings
- Catheter-Related Infections, Bacterial Infections, Bacteremia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% Octenidine with 30% 1-propanol and 45% 2-propanolDrug
Also called Octeniderm, Neo-Kodan
Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of >200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.
74% Ethanol with 10% 2-propanolDrug
Also called Softasept
Before insertion of the catheter, the entry site was disinfected with the assigned solution over an area of >200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Oct/Alc | Active comparator | Not described Receives: Drug: 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol |
| Alc | Active comparator | Not described Receives: Drug: 74% Ethanol with 10% 2-propanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin colonisation in cfu/cm2 at the insertion site; Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method); Incidence of catheter-associated bloodstream infection
Measured: For the duration of catheter placement plus 2 days
Secondary outcomes (1)
Comparison of therapy regimens regarding side effects and complications
Measured: For the duration of catheter placement plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startMay 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Catheterization, Central VenousStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Investigators
- Markus Dettenkofer, Prof. MD, Principal investigator, Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515151
- Sponsor's protocol ID
- NEO-0102
- Status last verified
- Aug 2007
- First submitted
- 10 Aug 2007
- Last updated
- 13 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000 Mar 7;132(5):391-402. doi: 10.7326/0003-4819-132-5-200003070-00009.
PubMed 10691590Dettenkofer M, Wenzler-Rottele S, Babikir R, Bertz H, Ebner W, Meyer E, Ruden H, Gastmeier P, Daschner FD; Hospital Infection Surveillance System for Patients with Hematologic/Oncologic Malignancies Study Group. Surveillance of nosocomial sepsis and pneumonia in patients with a bone marrow or peripheral blood stem cell transplant: a multicenter project. Clin Infect Dis. 2005 Apr 1;40(7):926-31. doi: 10.1086/428046. Epub 2005 Mar 4.
PubMed 15824981Raad I. Intravascular-catheter-related infections. Lancet. 1998 Mar 21;351(9106):893-8. doi: 10.1016/S0140-6736(97)10006-X. No abstract available.
PubMed 9525387Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004 Jan;30(1):62-7. doi: 10.1007/s00134-003-2045-z. Epub 2003 Nov 26.
PubMed 14647886O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol. 2002 Dec;23(12):759-69. doi: 10.1086/502007.
PubMed 12517020Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med. 2002 Jun 4;136(11):792-801. doi: 10.7326/0003-4819-136-11-200206040-00007.
PubMed 12044127Sedlock DM, Bailey DM. Microbicidal activity of octenidine hydrochloride, a new alkanediylbis[pyridine] germicidal agent. Antimicrob Agents Chemother. 1985 Dec;28(6):786-90. doi: 10.1128/AAC.28.6.786.
PubMed 3909955Buhrer C, Bahr S, Siebert J, Wettstein R, Geffers C, Obladen M. Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. J Hosp Infect. 2002 Aug;51(4):305-7. doi: 10.1053/jhin.2002.1249.
PubMed 12183146Tietz A, Frei R, Dangel M, Bolliger D, Passweg JR, Gratwohl A, Widmer AE. Octenidine hydrochloride for the care of central venous catheter insertion sites in severely immunocompromised patients. Infect Control Hosp Epidemiol. 2005 Aug;26(8):703-7. doi: 10.1086/502606.
PubMed 16156327Dettenkofer M, Jonas D, Wiechmann C, Rossner R, Frank U, Zentner J, Daschner FD. Effect of skin disinfection with octenidine dihydrochloride on insertion site colonization of intravascular catheters. Infection. 2002 Oct;30(5):282-5. doi: 10.1007/s15010-002-2182-2.
PubMed 12382087Bouza E, Alvarado N, Alcala L, Sanchez-Conde M, Perez MJ, Munoz P, Martin-Rabadan P, Rodriguez-Creixems M. A prospective, randomized, and comparative study of 3 different methods for the diagnosis of intravascular catheter colonization. Clin Infect Dis. 2005 Apr 15;40(8):1096-100. doi: 10.1086/428576. Epub 2005 Mar 17.
PubMed 15791507Eggimann P, Harbarth S, Constantin MN, Touveneau S, Chevrolet JC, Pittet D. Impact of a prevention strategy targeted at vascular-access care on incidence of infections acquired in intensive care. Lancet. 2000 May 27;355(9218):1864-8. doi: 10.1016/S0140-6736(00)02291-1.
PubMed 10866442Maki DG, Ringer M, Alvarado CJ. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet. 1991 Aug 10;338(8763):339-43. doi: 10.1016/0140-6736(91)90479-9.
PubMed 1677698Dettenkofer M, Wilson C, Gratwohl A, Schmoor C, Bertz H, Frei R, Heim D, Luft D, Schulz S, Widmer AF. Skin disinfection with octenidine dihydrochloride for central venous catheter site care: a double-blind, randomized, controlled trial. Clin Microbiol Infect. 2010 Jun;16(6):600-6. doi: 10.1111/j.1469-0691.2009.02917.x. Epub 2009 Aug 17.
PubMed 19686276
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Disinfection With Octenidine Dihydrochloride for the Prevention of Catheter-Associated Infections - A Double-Blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00515151
- Acronym / sponsor ID
- NEO-0102
- Conditions
- Catheterization, Central Venous, Catheter-Associated Infections, Bacterial Infections, Bacteremia
- Keywords
- Bloodstream Infection, Bacteremia, Central Venous Catheter, Alcohol, Disinfection, Octenidine Dihydrochloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- May 2002
- Study completion
- Apr 2005 (actual)
- First posted
- 13 Aug 2007 (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.
Health-care-acquired infections are of tremendous importance for patients, especially catheter-associated infections. More than 40% of all bloodstream infections are associated with central venous catheters (CVC; catheters which are inserted into a large vein near the heart). Of all patients that acquire such an infection 1% to 5% die as a result from it. The insertion site is the main source of contamination and infection. In general, bacteria of the skin are the cause of infection, especially in short-term CVCs (10-14 days). Therefore it is necessary to efficiently disinfect the skin for the preparation and care of CVC insertion sites. Several substances are used for disinfection. Alcohol-based disinfectants are mainly used in Central Europe, other preparations contain povidine-iodine or chlorhexidine. Alcoholic disinfectants have a rapid initial effect, chlorhexidine shows an additional remanent (longer lasting) effect. A further substance, octenidine dihydrochloride, also demonstrated a remanent effect in a pilot study with neurosurgical patients. The purpose of our study is to compare an alcohol-based disinfectant containing octenidine dihydrochloride with a pure alcoholic disinfectant regarding efficacy and tolerability in patients receiving a CVC for a minimum of 5 days.
Detailed description
Catheter-associated infections are one of the most eminent healthcare acquired infections. More than 40% of all bloodstream infections are associated with a central venous catheter (CVC)and between 1% and 5% of the affected patients die as a direct consequence of this infection. The most important microorganisms are gram-positive cocci (S. aureus, S. epidermidis). In intensive care units gram-negative microorganisms such as pseudomonas, acinetobacter and candida spp. are more frequent. The insertion site is the main source of contamination and infection in short-term CVCs (10-14 days. In this case the infection is caused by migration of microorganisms along the outside of the catheter. Contamination of the hub due to frequent manipulation is usually the source of infection in long-term CVCs. In this case the infection occurs intraluminally. An effective skin disinfection is the main measure of prevention before insertion of a CVC. The aim of this measure is the elimination of transient and the reduction of resident microorganisms around the insertion site. To achieve this, disinfectants on the basis of alcohol, povidone-iodine or chlorhexidine are applied. Alcohol-based disinfectants are preferred in Central Europe because of their rapid initial effect and broad microbiological spectrum. Chlorhexidine and povidone-Iodine in contrast to alcoholic disinfectants have a remanent effect which reduces regrowth of microorganisms beyond the immediate initial effect. To which extent remanent substances reduce colonization of the CVC extraluminally or the CVC-tip is still being disputed. In an earlier clinical trial a residual or remanent effect of 0.1% octenidine combined with propanol in microbial skin decontamination over a 24h period was shown in neurosurgical patients receiving a central line (CVC or peripherally inserted central catheter). The objective of this study is therefore to evaluate further the preventive impact and tolerability of a commercially available, alcohol-based antiseptic solution containing octenidine for the preparation and care of CVC insertion sites in a clinical setting in comparison with the results given by an alcoholic solution alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oct/Alc | Active comparator | Drug: 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol |
| Alc | Active comparator | Drug: 74% Ethanol with 10% 2-propanol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 years
- Medical indication for CVC with a planned duration of minimum 5 days
- Patient´s (or relative´s if applicable) written informed consent
Key exclusion criteria (9 listed)
- Known sensitisation against the proposed antiseptics
- Tunneled or implanted CVCs (e.g. Hickman Catheter)
- Administration of antimicrobial drugs for therapy (not prophylaxis) less than one week prior to catheterization
- Pre-existing bloodstream infection (i.e., fever and/or other signs of infection)
- Positive blood culture
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 |
|---|---|---|
| 0.1% Octenidine with 30% 1-propanol and 45% 2-propanolAlso: Octeniderm, Neo-KodanBefore insertion of the catheter, the entry site was disinfected with the assigned solution over an area of >200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days. | Drug | Oct/Alc |
| 74% Ethanol with 10% 2-propanolAlso: SoftaseptBefore insertion of the catheter, the entry site was disinfected with the assigned solution over an area of >200 cm² for at least one minute. The assigned solution was then applied for care of the entry site during the change of dressings, usually every 2 to 3 days. | Drug | Alc |
Primary outcome
Skin colonisation in cfu/cm2 at the insertion site; Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method); Incidence of catheter-associated bloodstream infection
Time frame: For the duration of catheter placement plus 2 days
1 secondary outcome
Comparison of therapy regimens regarding side effects and complications
Time frame: For the duration of catheter placement plus 30 days
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 13 Aug 2007.
- Background: PubMed 10691590Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000 Mar 7;132(5):391-402. doi: 10.7326/0003-4819-132-5-200003070-00009.
- Background: PubMed 15824981Dettenkofer M, Wenzler-Rottele S, Babikir R, Bertz H, Ebner W, Meyer E, Ruden H, Gastmeier P, Daschner FD; Hospital Infection Surveillance System for Patients with Hematologic/Oncologic Malignancies Study Group. Surveillance of nosocomial sepsis and pneumonia in patients with a bone marrow or peripheral blood stem cell transplant: a multicenter project. Clin Infect Dis. 2005 Apr 1;40(7):926-31. doi: 10.1086/428046. Epub 2005 Mar 4.
- Background: PubMed 9525387Raad I. Intravascular-catheter-related infections. Lancet. 1998 Mar 21;351(9106):893-8. doi: 10.1016/S0140-6736(97)10006-X. No abstract available.
- Background: PubMed 14647886Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004 Jan;30(1):62-7. doi: 10.1007/s00134-003-2045-z. Epub 2003 Nov 26.
- Background: PubMed 12517020O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol. 2002 Dec;23(12):759-69. doi: 10.1086/502007.
- Background: PubMed 12044127Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med. 2002 Jun 4;136(11):792-801. doi: 10.7326/0003-4819-136-11-200206040-00007.
- Background: PubMed 3909955Sedlock DM, Bailey DM. Microbicidal activity of octenidine hydrochloride, a new alkanediylbis[pyridine] germicidal agent. Antimicrob Agents Chemother. 1985 Dec;28(6):786-90. doi: 10.1128/AAC.28.6.786.
- Background: PubMed 12183146Buhrer C, Bahr S, Siebert J, Wettstein R, Geffers C, Obladen M. Use of 2% 2-phenoxyethanol and 0.1% octenidine as antiseptic in premature newborn infants of 23-26 weeks gestation. J Hosp Infect. 2002 Aug;51(4):305-7. doi: 10.1053/jhin.2002.1249.
- Background: PubMed 16156327Tietz A, Frei R, Dangel M, Bolliger D, Passweg JR, Gratwohl A, Widmer AE. Octenidine hydrochloride for the care of central venous catheter insertion sites in severely immunocompromised patients. Infect Control Hosp Epidemiol. 2005 Aug;26(8):703-7. doi: 10.1086/502606.
- Background: PubMed 12382087Dettenkofer M, Jonas D, Wiechmann C, Rossner R, Frank U, Zentner J, Daschner FD. Effect of skin disinfection with octenidine dihydrochloride on insertion site colonization of intravascular catheters. Infection. 2002 Oct;30(5):282-5. doi: 10.1007/s15010-002-2182-2.
- Background: PubMed 15791507Bouza E, Alvarado N, Alcala L, Sanchez-Conde M, Perez MJ, Munoz P, Martin-Rabadan P, Rodriguez-Creixems M. A prospective, randomized, and comparative study of 3 different methods for the diagnosis of intravascular catheter colonization. Clin Infect Dis. 2005 Apr 15;40(8):1096-100. doi: 10.1086/428576. Epub 2005 Mar 17.
- Background: PubMed 10866442Eggimann P, Harbarth S, Constantin MN, Touveneau S, Chevrolet JC, Pittet D. Impact of a prevention strategy targeted at vascular-access care on incidence of infections acquired in intensive care. Lancet. 2000 May 27;355(9218):1864-8. doi: 10.1016/S0140-6736(00)02291-1.
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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.
Markus Dettenkofer, Prof. MD principal investigator
Institute of Environmental Medicine and Hospital Epidemiology University Medical Center Freiburg, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.1% Octenidine with 30% 1-propanol and 45% 2-propanol and 74% Ethanol with 10% 2-propanol in people with Catheterization, Central Venous and Catheter-Associated Infections, run by University Hospital Freiburg at 2 sites in 2 countries.
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 3 inclusion and 9 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 13 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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?
Skin colonisation in cfu/cm2 at the insertion site; Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method); Incidence of catheter-associated bloodstream infection (time frame: For the duration of catheter placement plus 2 days). 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 NCT00515151, which also lists 14 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 13 Aug 2007.