Elective Craniotomy-candidated PatientsPhase 1/2NCT03466645
The Effectiveness of Vancomycin in Comarison With Cefazolin in Prevention of SSI After Craniotomy
A Phase 1/2 study testing Vancomycin and Cefazolin in people with Elective Craniotomy-candidated Patients, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Surgical-site infection is the most commonly reported nosocomial infection in patients undergoing surgery and 3rd most nosocomial infection in hospitalized patients. The SSI is associated with increases of length of hospitalization for 6 days and increases the hospital's cost by $ 300. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Craniotomy-candidated Patients
- What is being tested?
- Vancomycin and Cefazolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIran
- Study dates
- 1 Apr 2018to 1 Aug 2019
- Phase
- Phase 1/2
- 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
- age 18 years and above
- elective surgical patients
- No pre-surgery infection
- Do not use antibiotics before surgery
- Insensitivity to beta-lactam antibiotics
Who cannot join
- cranioplasty
- Failure to follow the patient
- The patient's unwillingness to continue participating in the research project
- Death of the patient
Trial locations and contacts
1 site in 1 country.
Iran1 site
Isfahan university of medical science.
Isfahan
Rasool Mohammadi, student, +989365725957, rasool.mohammadi1993@yahoo.com
About this study
Surgical-site infection is the most commonly reported nosocomial infection in patients undergoing surgery and 3rd most nosocomial infection in hospitalized patients. The SSI is associated with increases of length of hospitalization for 6 days and increases the hospital's cost by $ 300.
Because of these, prevention of SSI with appropriate antibiotic is essential.
- Conditions
- Elective Craniotomy-candidated Patients
- Being tested
- Vancomycin, Cefazolin
- Keywords
- SSI, elective Craniotomy, Vancomycin, Cefazolin, Antibiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
The 1st group receives vancomycin an hour before craniotomy
CefazolinDrug
The 2nd group receives cefazolin an hour before craniotomy
| Study group | Role | What they receive |
|---|---|---|
| 1st group, receiving vancomycin | Active comparator | The 1st group receives vancomycin an hour before craniotomy Receives: Drug: Vancomycin |
| 2nd group, receiving cefazolin | Active comparator | The 2nd group receives cefazolin an hour before craniotomy Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection rate
compare of infection rate in 2 groups
Measured: Until 90 days after admission
Secondary outcomes (2)
length of hospitalization
compare the length of hospitalization in 2 groups
Measured: Until 90 days after admission
raise of ESR & CRP
compare the raise of ESR \& CRP in 2 groups
Measured: Until 90 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Craniotomy-candidated PatientsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Dehghani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466645
- Sponsor's protocol ID
- Isfahan University
- Status last verified
- Dec 2017
- First submitted
- 9 Mar 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Vancomycin in Comarison With Cefazolin in Prevention of SSI After Craniotomy
- ClinicalTrials.gov ID
- NCT03466645
- Acronym / sponsor ID
- Isfahan University
- Conditions
- Elective Craniotomy-candidated Patients
- Keywords
- SSI, elective Craniotomy, Vancomycin, Cefazolin, Antibiotic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 15 Mar 2018 (actual)
- 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.
Surgical-site infection is the most commonly reported nosocomial infection in patients undergoing surgery and 3rd most nosocomial infection in hospitalized patients. The SSI is associated with increases of length of hospitalization for 6 days and increases the hospital's cost by $ 300.
Because of these, prevention of SSI with appropriate antibiotic is essential.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st group, receiving vancomycin | Active comparator | Drug: VancomycinThe 1st group receives vancomycin an hour before craniotomy |
| 2nd group, receiving cefazolin | Active comparator | Drug: CefazolinThe 2nd group receives cefazolin an hour before craniotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 years and above
- elective surgical patients
- No pre-surgery infection
- Do not use antibiotics before surgery
- Insensitivity to beta-lactam antibiotics
Key exclusion criteria (4 listed)
- cranioplasty
- Failure to follow the patient
- The patient's unwillingness to continue participating in the research project
- Death of the patient
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 |
|---|---|---|
| VancomycinThe 1st group receives vancomycin an hour before craniotomy | Drug | 1st group, receiving vancomycin |
| CefazolinThe 2nd group receives cefazolin an hour before craniotomy | Drug | 2nd group, receiving cefazolin |
Primary outcome
infection rate
Time frame: Until 90 days after admission
compare of infection rate in 2 groups
2 secondary outcomes
length of hospitalization
Time frame: Until 90 days after admission
raise of ESR & CRP
Time frame: Until 90 days after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vancomycin and Cefazolin in people with Elective Craniotomy-candidated Patients, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 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 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rasool Mohammadi, Student (+989365725957, rasool.mohammadi1993@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection rate (time frame: Until 90 days after admission). 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 15 Mar 2018.