AmputationNCT00392028
Penetration of Ertapenem Into Bone
A study testing ertapenem in people with Amputation, run by HaEmek Medical Center, Israel at 3 sites in Israel.
Trial summary
The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amputation
- What is being tested?
- ertapenem
- How many people
- 12 participants
- Where
- 3 sitesIsrael
- Study dates
- Nov 2006to Jul 2007
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Diabetes Mellitus or Peripheral Vascular Disease
- Undergoing bellow knee amputation with or without gangrene
- Patients without clinical signs of acute infection
- Creatinine Clearence more than 60 cc/ min
Who cannot join
- Known hypersensitivity to any component of ertapenem or to other drugs in the same class.
- Patients who have demonstrated anaphylactic reactions to beta-lactams.
- CNS disorders (e.g., brain lesions or history of seizures).
- Patient treated with other antibiotics at least 72 hours.
- Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception.
- Patient or legal representative of the patient is unable to provide written informed consent for any reason.
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- Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug to the patient.
- Neutropenia
- Renal failure
- Hepatic Insufficiency: > x 2 upper limit.
- A need for any additional concomitant systemic antibacterial agent.
- Life expectancy less than 6 month
- Patient is undergoing immunosuppressive therapy, including use of high dose corticosteroids (e.g.,20 mg or more prednisone or equivalent per day)
- Patient is in a situation or has a condition which, in the investigator's opinion, may interfere with optimal participation in the study.
- Participation in an another clinical trial.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Ha'Emek Medical Center
Afula, 18101
Haemek Medical Center INFECTIOUS DISEASES UNIT
Afula, 18101
Haemek Medical Center INFECTIOUS DISEASES UNIT
Afula
About this study
Official title: Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation
The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues
Read the detailed description
Twelve patients with D.M or P.V.D who are undergoing bellow knee amputation with or without gangrene.
Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements (TcPO2) on the dorsal side of the mid foot of the affected limb.
Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC:
- -2 days prior the amputation
- -1 day prior the amputation
- 1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion, prior the planned amputation.
Blood samples (approximately 6ml each) will be collected before Ertapenem administration, simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery
- Conditions
- Amputation
- Being tested
- ertapenem
- Keywords
- Ertapenem, Bone drug level, Blood drug level, Tissue drug level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ertapenemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
blood,tissue and bone drug levels
Measured: 3 days each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startNov 2006
- Study completionJul 2007 (estimated)
Why it stopped: no recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Ruth Kitzes, Study director, Clinical Pharmacology Unit, Carmel Medical Center, Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392028
- Sponsor's protocol ID
- p1101v1
- Status last verified
- Jul 2007
- First submitted
- 24 Oct 2006
- Last updated
- 13 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation
- ClinicalTrials.gov ID
- NCT00392028
- Acronym / sponsor ID
- p1101v1
- Conditions
- Amputation
- Keywords
- Ertapenem, Bone drug level, Blood drug level, Tissue drug level
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no recruitment
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Jul 2007 (estimated)
- First posted
- 25 Oct 2006 (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.
The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues
Detailed description
Twelve patients with D.M or P.V.D who are undergoing bellow knee amputation with or without gangrene.
Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements (TcPO2) on the dorsal side of the mid foot of the affected limb.
Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC:
- -2 days prior the amputation
- -1 day prior the amputation
- 1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion, prior the planned amputation.
Blood samples (approximately 6ml each) will be collected before Ertapenem administration, simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18
- Diabetes Mellitus or Peripheral Vascular Disease
- Undergoing bellow knee amputation with or without gangrene
- Patients without clinical signs of acute infection
- Creatinine Clearence more than 60 cc/ min
Key exclusion criteria (15 listed)
- Known hypersensitivity to any component of ertapenem or to other drugs in the same class.
- Patients who have demonstrated anaphylactic reactions to beta-lactams.
- CNS disorders (e.g., brain lesions or history of seizures).
- Patient treated with other antibiotics at least 72 hours.
- Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception.
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 |
|---|---|---|
| ertapenem | Drug | – |
Primary outcome
blood,tissue and bone drug levels
Time frame: 3 days each patient
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2007.
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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.
Ruth Kitzes study director
Clinical Pharmacology Unit, Carmel Medical Center, Haifa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ertapenem in people with Amputation, run by HaEmek Medical Center, Israel at 3 sites in Israel.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 13 Jul 2007. 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 Israel. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
blood,tissue and bone drug levels (time frame: 3 days each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2007.