Infection Prophylaxis in Colo Rectal SurgeryPhase 4NCT00613769
Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
A Phase 4 study testing trimethoprim-sulfamethoxazole + metronidazole and cefuroxime and metronidazole in people with Infection Prophylaxis in Colo Rectal Surgery, run by Halmstad County Hospital at 6 sites in Sweden.
Trial summary
The current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Prophylaxis in Colo Rectal Surgery
- What is being tested?
- trimethoprim-sulfamethoxazole + metronidazole and cefuroxime and metronidazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,073 participants
- Where
- 6 sitesSweden
- Study dates
- Sep 2007to May 2012
- 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
- Age >= 18 years
- Planned clean/clean-contaminated colorectal resection will be performed
- Understand spoken and written swedish language
Who cannot join
- Hypersensibility to the test or control drug
- Severe liver failure
- Blood dyscrasia
- Ileus or gastric retention
- Current visceral perforation
- Current treatment with antibiotics
Show all 14Show fewer
- Current treatment with steroids
- Cytotoxic or radiation therapy within 4 weeks of the planned operation
- Active IBD (inflammatory bowel disease)
- Incapability to swallow tablets
- Other study interfering with this study
- Current pregnancy
- Bad regulated diabetes
- Current enterocutaneous or colocutaneous fistula
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Department of Surgery, University hospital Sahlgrenska/Östra
Gothenburg, 416 85
Department of Surgery and oncology, Halland Hospital in Halmstad
Halmstad, 301 85
Department of surgery, Community Hospital i Karlskrona
Karlskrona, 371 85
Vrinnevi hospital
Norrköping, 601 82
Department of surgery
Skövde, 541 85
Department of Surgery, NU-hospitals
Uddevalla, 451 80
About this study
Official title: A Prospective, Randomized, Blind, Multicenter Trial Comparing Orally Administered Trimethoprim-sulfamethoxazole With Intravenously Administered Cefuroxime and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
The current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first line of treatment for abdominal surgical infections.
Serval Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole.
Read more
The combination is economical and believed to be effective but hitherto the outcome have not been properly researched.
The aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.
- Being tested
- trimethoprim-sulfamethoxazole + metronidazole, cefuroxime and metronidazole
- Keywords
- Surgical site infections
- 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.
trimethoprim-sulfamethoxazole + metronidazoleDrug
trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.
cefuroxime and metronidazoleDrug
cefuromime 1500mg i.v. + metronidazole 1500mg i.v.
| Study group | Role | What they receive |
|---|---|---|
| ordinary per operative prophylaxis | Active comparator | cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia Receives: Drug: cefuroxime and metronidazole |
| Per oral alternative | Experimental | Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation Receives: Drug: trimethoprim-sulfamethoxazole + metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous-,subcutaneous and intraabdominal infections
Measured: 4 weeks
Secondary outcomes (5)
Non infectious wound complications
Measured: 4 weeks
Complications to the anastomosis
Measured: 4 weeks
Adverse reaction of given drug
Measured: 4 weeks
Other post operative infections
Measured: During hospital stay
Septicaemia
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Prophylaxis in Colo Rectal SurgeryStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halmstad County Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claes Hjalmarsson, Halmstad County Hospital
- Investigators
- Claes Hjalmarsson, MD,PhD, Principal investigator, Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613769
- Sponsor's protocol ID
- TSM
- Other IDs
- EudraCT number 2006-006575-20
- Status last verified
- Sep 2012
- First submitted
- 31 Jan 2008
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Blind, Multicenter Trial Comparing Orally Administered Trimethoprim-sulfamethoxazole With Intravenously Administered Cefuroxime and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00613769
- Acronym / sponsor ID
- TSM
- Keywords
- Surgical site infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,073 participants (actual)
- Lead sponsor
- Halmstad County HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Feb 2008 (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 current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first line of treatment for abdominal surgical infections.
Serval Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole.
The combination is economical and believed to be effective but hitherto the outcome have not been properly researched.
The aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ordinary per operative prophylaxis | Active comparator | Drug: cefuroxime and metronidazolecefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia |
| Per oral alternative | Experimental | Drug: trimethoprim-sulfamethoxazole + metronidazoleTrimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years
- Planned clean/clean-contaminated colorectal resection will be performed
- Understand spoken and written swedish language
Key exclusion criteria (14 listed)
- Hypersensibility to the test or control drug
- Severe liver failure
- Blood dyscrasia
- Ileus or gastric retention
- Current visceral perforation
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 |
|---|---|---|
| trimethoprim-sulfamethoxazole + metronidazoletrimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o. | Drug | Per oral alternative |
| cefuroxime and metronidazolecefuromime 1500mg i.v. + metronidazole 1500mg i.v. | Drug | ordinary per operative prophylaxis |
Primary outcome
Cutaneous-,subcutaneous and intraabdominal infections
Time frame: 4 weeks
5 secondary outcomes
Non infectious wound complications
Time frame: 4 weeks
Complications to the anastomosis
Time frame: 4 weeks
Adverse reaction of given drug
Time frame: 4 weeks
Other post operative infections
Time frame: During hospital stay
Septicaemia
Time frame: 4 weeks
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 28 Sep 2012.
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.
Claes Hjalmarsson, MD,PhD principal investigator
Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing trimethoprim-sulfamethoxazole + metronidazole and cefuroxime and metronidazole in people with Infection Prophylaxis in Colo Rectal Surgery, run by Halmstad County Hospital at 6 sites in Sweden.
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 14 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 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. 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?
Cutaneous-,subcutaneous and intraabdominal infections (time frame: 4 weeks). 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 28 Sep 2012.