Blood Antibiotic LevelsPhase 3NCT02838940
Preventive Antibiotic Serum Levels During Caesarean Section
A Phase 3 study testing Blood samples. and Cefazolin in people with Blood Antibiotic Levels, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Background Preventive antibiotic treatment before performing invasive procedures is a basic element in preventing infections. The essence of preventive antibiotic treatment is strengthening the defense mechanisms of the immune system by preserving a certain drug levels in the blood. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Antibiotic Levels
- What is being tested?
- Blood samples. and Cefazolin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2019
- Phase
- Phase 3
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age of 37 weeks and above.
- Women who arrive to elective cesareans.
- Age of women: 18-50 years old.
Who cannot join
- Suspected clinical / laboratory active infection
- urgent surgery
- Sensitivity to penicillin or cephalosporins antibiotics that requires antibiotics change.
- Women who received the week before surgery antibiotic treatment
Trial locations and contacts
No sites are listed yet.
About this study
Background
Preventive antibiotic treatment before performing invasive procedures is a basic element in preventing infections. The essence of preventive antibiotic treatment is strengthening the defense mechanisms of the immune system by preserving a certain drug levels in the blood. The timing of giving the antibiotics is very important. Several research groups have tried to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in serum and adipose tissue in women during cesarean. These groups presented conflicting research results.
Read more
OBJECTIVE
This study will discuss the preventive antibiotic treatment levels accepted prior cesareans, to determine:
- What are the factors affecting the level of drug in the blood?
- Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal Inhibitory Concentration)?
- Is the provision of usual preventive care also addresses the situations of metabolic disorder?
Read the detailed description
Background
Preventive antibiotic treatment before performing invasive procedures is a basic element in preventing infections. The essence of preventive antibiotic treatment is strengthening the defense mechanisms of the immune system by preserving a certain drug levels in the blood. The timing of giving the antibiotics is very important. Several research groups have tried to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in serum and adipose tissue in women during cesarean. These groups presented conflicting research results.
OBJECTIVE
This study will discuss the preventive antibiotic treatment levels accepted prior cesareans, to determine:
- What are the factors affecting the level of drug in the blood?
- Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal Inhibitory Concentration)?
- Is the provision of usual preventive care also addresses the situations of metabolic disorder?
PATIENTS \& METHODS
Women that meet the inclusion criteria and are about to undergo cesarean in different indications, in elective and urgent way.
- Before performing TIMEOUT outside the surgery room, The investigators will explanation about the process and purpose of the study, and informed consent will be obtained.
- Prior to the anesthesia by an anesthesiologist, the women will receive one dose of 1 g Cefazolin the usual loading dose. Women with a BMI over 30 will receive Cefazolin of about 2 grams.
- With the beginning of the first incision in the skin, first blood sample will be taken to test levels of antibiotics in serum.
- Second blood sample to test drug levels in serum will be taken while closing the surgical incision in the skin at the end of the operation.
- The continuation of post surgery recovery process will be as usual, in accordance with departmental protocols.
With the results of tissue and serum samples, segmentation which compares the drug levels in the different tissues will be performed.Also, the correlation between drug levels in women with different BMI and morbidities that may cause measurable or not pharmacokinetic changes will be examined.
- Conditions
- Blood Antibiotic Levels
- Being tested
- Blood samples., Cefazolin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples.Procedure or surgery
At the beginning of the first incision in the skin, first blood sample will be taken for levels of antibiotics in serum test.
Second blood sample for drug levels in serum test, will be taken while closing the surgical incision in the skin at the end of the operation.
CefazolinDrug
According to the ward protocol prior to the anesthesia by an anesthesiologist, the women will receive one dose of 1 g Cefazolin the usual loading dose. Women with a BMI over 30 will receive Cefazolin of about 2 grams.
| Study group | Role | What they receive |
|---|---|---|
| cesarean in different indications | Experimental | Women that are about to undergo an elective cesarean in different indications. Receives: Procedure: Blood samples.; Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood antibiotic levels
Blood MIC(Minimal Inhibitory Concentration) levels of antibiotic will be checked at first incision and at the time of closing surgery.
Measured: 30 min- 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Antibiotic LevelsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yariv Yogev, professor, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838940
- Sponsor's protocol ID
- 0147-16-TLV
- Status last verified
- Jul 2016
- First submitted
- 29 May 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Antibiotic Serum Levels During Caesarean Section
- ClinicalTrials.gov ID
- NCT02838940
- Acronym / sponsor ID
- 0147-16-TLV
- Conditions
- Blood Antibiotic Levels
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 Jul 2016 (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.
Background
Preventive antibiotic treatment before performing invasive procedures is a basic element in preventing infections. The essence of preventive antibiotic treatment is strengthening the defense mechanisms of the immune system by preserving a certain drug levels in the blood. The timing of giving the antibiotics is very important. Several research groups have tried to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in serum and adipose tissue in women during cesarean. These groups presented conflicting research results.
OBJECTIVE
This study will discuss the preventive antibiotic treatment levels accepted prior cesareans, to determine:
- What are the factors affecting the level of drug in the blood?
- Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal Inhibitory Concentration)?
- Is the provision of usual preventive care also addresses the situations of metabolic disorder?
Detailed description
Background
Preventive antibiotic treatment before performing invasive procedures is a basic element in preventing infections. The essence of preventive antibiotic treatment is strengthening the defense mechanisms of the immune system by preserving a certain drug levels in the blood. The timing of giving the antibiotics is very important. Several research groups have tried to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in serum and adipose tissue in women during cesarean. These groups presented conflicting research results.
OBJECTIVE
This study will discuss the preventive antibiotic treatment levels accepted prior cesareans, to determine:
- What are the factors affecting the level of drug in the blood?
- Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal Inhibitory Concentration)?
- Is the provision of usual preventive care also addresses the situations of metabolic disorder?
PATIENTS \& METHODS
Women that meet the inclusion criteria and are about to undergo cesarean in different indications, in elective and urgent way.
- Before performing TIMEOUT outside the surgery room, The investigators will explanation about the process and purpose of the study, and informed consent will be obtained.
- Prior to the anesthesia by an anesthesiologist, the women will receive one dose of 1 g Cefazolin the usual loading dose. Women with a BMI over 30 will receive Cefazolin of about 2 grams.
- With the beginning of the first incision in the skin, first blood sample will be taken to test levels of antibiotics in serum.
- Second blood sample to test drug levels in serum will be taken while closing the surgical incision in the skin at the end of the operation.
- The continuation of post surgery recovery process will be as usual, in accordance with departmental protocols.
With the results of tissue and serum samples, segmentation which compares the drug levels in the different tissues will be performed.Also, the correlation between drug levels in women with different BMI and morbidities that may cause measurable or not pharmacokinetic changes will be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cesarean in different indications | Experimental | Procedure: Blood samples., Drug: CefazolinWomen that are about to undergo an elective cesarean in different indications. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestational age of 37 weeks and above.
- Women who arrive to elective cesareans.
- Age of women: 18-50 years old.
Key exclusion criteria (4 listed)
- Suspected clinical / laboratory active infection
- urgent surgery
- Sensitivity to penicillin or cephalosporins antibiotics that requires antibiotics change.
- Women who received the week before surgery antibiotic treatment
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 |
|---|---|---|
| Blood samples.At the beginning of the first incision in the skin, first blood sample will be taken for levels of antibiotics in serum test. Second blood sample for drug levels in serum test, will be taken while closing the surgical incision in the skin at the end of the operation. | Procedure or surgery | cesarean in different indications |
| CefazolinAccording to the ward protocol prior to the anesthesia by an anesthesiologist, the women will receive one dose of 1 g Cefazolin the usual loading dose. Women with a BMI over 30 will receive Cefazolin of about 2 grams. | Drug | cesarean in different indications |
Primary outcome
Blood antibiotic levels
Time frame: 30 min- 2 hours.
Blood MIC(Minimal Inhibitory Concentration) levels of antibiotic will be checked at first incision and at the time of closing surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Yariv Yogev, professor principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood samples. and Cefazolin in people with Blood Antibiotic Levels, run by Tel-Aviv Sourasky Medical Center.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yariv Yogev, professor (052-7360616, yarivy@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood antibiotic levels (time frame: 30 min- 2 hours.). 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 20 Jul 2016.