Overview
Sponsor-declared trial summary
Undergoing hysterectomy
To study post-hysterectomy infections and to compare the use of azithromycin and cefuroxime vs single cefuroxime in antibiotic prophylaxis
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 24 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517508-12-00
- EudraCT number
- 2021-003467-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To study post-hysterectomy infections and to compare the use of azithromycin and cefuroxime vs single cefuroxime in antibiotic prophylaxis
Conditions and MedDRA coding
Undergoing hysterectomy
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Women undergoing hysterectomy for a benign indication in a public hospital in Finland who have not any contraindications for azithromycin or cefuroxime. The person must understand the information given in finnish or swedish.
Exclusion criteria 1
- Inability to understand the study protocol. Allergy for either cefuroxime or azithromycin. Congenital or acquired prolonged QTc interval. Use of medicines that may prolong QTc interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilidi, amiodarone and sotalol). Use of SSRI medication and prolonged QTc interval.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Deep wound and pelvic organ infections up to 30 days postoperatively
Secondary endpoints 1
- Surficial infections and other infections, such has urine tract infections, and fever over 38 ℃ over 2 days.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1167043 · ATC
- Active substance
- Azithromycin
- Substance synonyms
- AZITROMICINA
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01FA10 — AZITHROMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- ORAL
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- HUS Naistenklinikka
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- HUS Naistenklinikka
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 2,278 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-10-24 | 2024-10-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma | 5 |
| Recruitment arrangements (for publication) | Tarvittaessa toimitamme lisatietoja | 1 |
| Subject information and informed consent form (for publication) | Tutkittavan_tiedote | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-06 | Finland | Acceptable 2024-10-24
|
2024-10-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-20 | Finland | Acceptable 2024-10-24
|
2026-01-20 |