Surgical Site InfectionsPhase 4NCT01138852
Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section
A Phase 4 study testing Ampicillin-sulbactam and Cefuroxime in people with Surgical Site Infections, run by Attikon Hospital.
Trial summary
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- Ampicillin-sulbactam and Cefuroxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Dec 2008
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing a cesarean delivery were eligible.
Who cannot join
- Patients with known hypersensitivity to penicillin or cephalosporins.
- Patients who required concomitant antibiotic therapy during surgery.
- Patients who have received antibiotics during the 72 hours immediately preceding their enrollment.
- Patients whose postpartum fever was clearly associated with other known causes.
About this study
Official title: Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.
Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.
Read the detailed description
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.
The investigation was designed to evaluate the efficacy and safety of a single dose of ampicillin/sulbactam 3g compared to a single dose of cefuroxime 1.5g in preventing postoperative morbidity. The primary outcome was development of an infection either at the surgical site or elsewhere e.g. urinary tract infection.
A prospective randomized controlled study was performed from July 2004 to December 2008 in one major tertiary care hospital in Athens Greece. All patients undergoing a cesarean delivery were eligible.Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped.
- Conditions
- Surgical Site Infections
- Being tested
- Ampicillin-sulbactam, Cefuroxime
- Keywords
- post-cesarean infections, ampicillin-sulbactam, cefuroxime, cesarean
- 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.
Ampicillin-sulbactamDrug
Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped
CefuroximeDrug
Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped
| Study group | Role | What they receive |
|---|---|---|
| ampicillin-sulbactam | Experimental | This is the drug used to prevent post-cesarean infection Receives: Drug: Ampicillin-sulbactam; Drug: Cefuroxime |
| cefuroxime | Active comparator | This drug was compared to ampicillin sulbactam for prevention of infection Receives: Drug: Ampicillin-sulbactam; Drug: Cefuroxime |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJul 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138852
- Sponsor's protocol ID
- UHATpro1
- Status last verified
- Jul 2004
- First submitted
- 4 Jun 2010
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Williams MJ, Carvalho Ribeiro do Valle C, Gyte GM. Different classes of antibiotics given to women routinely for preventing infection at caesarean section. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD008726. doi: 10.1002/14651858.CD008726.pub3.
PubMed 33661539Ziogos E, Tsiodras S, Matalliotakis I, Giamarellou H, Kanellakopoulou K. Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study. BMC Infect Dis. 2010 Nov 30;10:341. doi: 10.1186/1471-2334-10-341.
PubMed 21118502
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study
- ClinicalTrials.gov ID
- NCT01138852
- Acronym / sponsor ID
- UHATpro1
- Conditions
- Surgical Site Infections
- Keywords
- post-cesarean infections, ampicillin-sulbactam, cefuroxime, cesarean
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jun 2010 (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 efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.
Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.
Detailed description
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.
The investigation was designed to evaluate the efficacy and safety of a single dose of ampicillin/sulbactam 3g compared to a single dose of cefuroxime 1.5g in preventing postoperative morbidity. The primary outcome was development of an infection either at the surgical site or elsewhere e.g. urinary tract infection.
A prospective randomized controlled study was performed from July 2004 to December 2008 in one major tertiary care hospital in Athens Greece. All patients undergoing a cesarean delivery were eligible.Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ampicillin-sulbactam | Experimental | Drug: Ampicillin-sulbactam, Drug: CefuroximeThis is the drug used to prevent post-cesarean infection |
| cefuroxime | Active comparator | Drug: Ampicillin-sulbactam, Drug: CefuroximeThis drug was compared to ampicillin sulbactam for prevention of infection |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing a cesarean delivery were eligible.
Key exclusion criteria (4 listed)
- Patients with known hypersensitivity to penicillin or cephalosporins.
- Patients who required concomitant antibiotic therapy during surgery.
- Patients who have received antibiotics during the 72 hours immediately preceding their enrollment.
- Patients whose postpartum fever was clearly associated with other known causes.
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 |
|---|---|---|
| Ampicillin-sulbactamPatients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped | Drug | ampicillin-sulbactam, cefuroxime |
| CefuroximePatients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped | Drug | ampicillin-sulbactam, cefuroxime |
Primary outcome
Not reported in the source record.
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 7 Jun 2010.
- Derived from this study: PubMed 33661539Williams MJ, Carvalho Ribeiro do Valle C, Gyte GM. Different classes of antibiotics given to women routinely for preventing infection at caesarean section. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD008726. doi: 10.1002/14651858.CD008726.pub3.
- Derived from this study: PubMed 21118502Ziogos E, Tsiodras S, Matalliotakis I, Giamarellou H, Kanellakopoulou K. Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study. BMC Infect Dis. 2010 Nov 30;10:341. doi: 10.1186/1471-2334-10-341.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ampicillin-sulbactam and Cefuroxime in people with Surgical Site Infections, run by Attikon Hospital.
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 1 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: finished, as of the sponsor's last update on 7 Jun 2010. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138852, which also lists 2 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 7 Jun 2010.