Infection Post OpNCT05337566
Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections
A study testing Azithromycin Pill + Cefuroxime in people with Infection Post Op and Hysterectomy, run by Helsinki University Central Hospital at 6 sites in Finland.
Trial summary
During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infection Post Op, Hysterectomy, Antibiotics
- What is being tested?
- Azithromycin Pill + Cefuroxime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,278 participants
- Where
- 6 sitesFinland
- Study dates
- 5 Sep 2022to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing hysterectomy for benign indication in University Hospitals (Helsinki University Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital and Kuopio University Hospital) who have not any contraindications for azithromycin or cefuroxime.
Who cannot join
- Inability to understand the study protocol.
- Allergy for either cefuroxime or azithromycin.
- Congenital or acquired prolonged Q-T-corrected interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family,
- Electrocardiogram will be checked for all the participants.
- Use of medicines that may prolong Q-T-corrected interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilide, amiodarone and sotalol).
- Use of selective serotonin reuptake inhibitor medication and prolonged Q-T-corrected interval.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Finland6 sites, 6 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Päivi K Rahkola-Soisalo, Adj prof,MD, +358 50 4270411, paivi.rahkola-soisalo@hus.fi
Ninja Savonius, MD, +358503466986, ninja.savonius@hus.fi
- Recruiting
Jyväskylä Central Hospital
Jyväskylä, 40620
Jaana Seikkula, PhD, +358 41 548 3562, jaana.seikkula@fimnet.fi
- Recruiting
Kuopio University Central Hospital
Kuopio, 70029
Henna Kärkkäinen, PhD, +358 44 7172741, henna.karkkainen@kuh.fi
- Recruiting
Oulu University Central Hospital
Oulu, PL23
Sari Koivurova, PhD, +358 8 3150211, sari.koivurova@ppshp.fi
- Recruiting
Tampere University Central Hospital
Tampere, 33521
Riikka Niemi, PhD, +358 3 31169083, riikka.niemi@pshp.fi
Elina Ylilehto, PhD, MD
- Recruiting
Turku University Central Hospital
Turku
Pia Heinonen, PhD, +358 2 313 5002, pia.heinonen@tyks.fi
About this study
Official title: Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime
During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.
- Conditions
- Infection Post Op, Hysterectomy, Antibiotics, Prophylactic
- Being tested
- Azithromycin Pill + Cefuroxime, Placebo + Cefuroxime
- Keywords
- postoperative, infection, hysterectomy, antibiotics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Pill + CefuroximeDrug
Azithromycin 500 mg (2 tablets) per orally when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
Placebo + CefuroximeDrug
Placebo (2 tablets) per orally in the evening when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin + Cefuroxime | Experimental | Changed with renewed study permissions:
These patients will receive Azithromycin 500 mg (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more) in the operating theatre before the incision.
The previous description:
These patients will receive Azithromycin 500 mg (2 tablets) per orally in the evening before the operation and single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision. Receives: Drug: Azithromycin Pill + Cefuroxime |
| Placebo + Cefuroxime | Active comparator | Changed with new study permissions:
These patients will receive placebo (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more)in the operating theatre before the incision.
The previous description:
These patients will receive placebo (2 tablets) per orally in the evening before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision. Receives: Drug: Placebo + Cefuroxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of post-hysterectomy episodes with deep infections
Number of deep wound and pelvic organ infection episodes reported by patients and doctors
Measured: Deep infections that occur between the first and 30th postoperative day after hysterectomy
Secondary outcomes (1)
Number of other post-hysterectomy infections or fever episodes
Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days
Measured: Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start5 Sep 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Post OpStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital, Jyväskylä Central Hospital
- Responsible party
- Principal investigator, Päivi Rahkola-Soisalo, Helsinki University Central Hospital
- Investigators
- Päivi Rahkola-Soisalo, Adj prof, MD, Principal investigator, Helsinki University Central HospitalTomi Mikkola, Prof, MD, Study chair, Helsinki University Central HospitalPäivi Rahkola-Soisalo, Adj prof, MD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337566
- Sponsor's protocol ID
- HUS/117/2022
- Other IDs
- 2021-003467-10
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime
- ClinicalTrials.gov ID
- NCT05337566
- Acronym / sponsor ID
- HUS/117/2022
- Conditions
- Infection Post Op, Hysterectomy, Antibiotics, Prophylactic
- Keywords
- postoperative, infection, hysterectomy, antibiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,278 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Turku, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital, Jyväskylä Central Hospital
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Apr 2022 (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.
During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.
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 |
|---|---|---|
| Azithromycin + Cefuroxime | Experimental | Drug: Azithromycin Pill + CefuroximeChanged with renewed study permissions: These patients will receive Azithromycin 500 mg (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more) in the operating theatre before the incision. The previous description: These patients will receive Azithromycin 500 mg (2 tablets) per orally in the evening before the operation and single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision. |
| Placebo + Cefuroxime | Active comparator | Drug: Placebo + CefuroximeChanged with new study permissions: These patients will receive placebo (2 tablets) per orally on the operation day when they arrive to the hospital and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose bosy mass index is 30 or more)in the operating theatre before the incision. The previous description: These patients will receive placebo (2 tablets) per orally in the evening before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing hysterectomy for benign indication in University Hospitals (Helsinki University Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital and Kuopio University Hospital) who have not any contraindications for azithromycin or cefuroxime.
Key exclusion criteria (6 listed)
- Inability to understand the study protocol.
- Allergy for either cefuroxime or azithromycin.
- Congenital or acquired prolonged Q-T-corrected interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family,
- Electrocardiogram will be checked for all the participants.
- Use of medicines that may prolong Q-T-corrected interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilide, amiodarone and sotalol).
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 |
|---|---|---|
| Azithromycin Pill + CefuroximeAzithromycin 500 mg (2 tablets) per orally when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision | Drug | Azithromycin + Cefuroxime |
| Placebo + CefuroximePlacebo (2 tablets) per orally in the evening when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision | Drug | Placebo + Cefuroxime |
Primary outcome
Number of post-hysterectomy episodes with deep infections
Time frame: Deep infections that occur between the first and 30th postoperative day after hysterectomy
Number of deep wound and pelvic organ infection episodes reported by patients and doctors
1 secondary outcome
Number of other post-hysterectomy infections or fever episodes
Time frame: Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- 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.
Päivi Rahkola-Soisalo, Adj prof, MD principal investigator
Helsinki University Central Hospital
Tomi Mikkola, Prof, MD study chair
Helsinki University Central Hospital
Päivi Rahkola-Soisalo, Adj prof, MD study director
Helsinki University Central Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin Pill + Cefuroxime in people with Infection Post Op and Hysterectomy, run by Helsinki University Central Hospital at 6 sites in Finland.
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 6 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Päivi K Rahkola-Soisalo, Adj prof,MD (+358504270411, paivi.rahkola-soisalo@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of post-hysterectomy episodes with deep infections (time frame: Deep infections that occur between the first and 30th postoperative day after hysterectomy). 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 22 Sep 2026.