Clinical trial • Phase IV • Other
AZITHROMYCIN for Hysterectomy | Postoperative infection
Phase IV trial of AZITHROMYCIN for Hysterectomy | Postoperative infection.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Hysterectomy | Postoperative infection
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 06-10-2024
- First CTIS Authorization Date
- 24-10-2024
Trial design
Single cefuroxime (standard prophylaxis) — not specified in CTIS; Azithromycin (product AZITHROMYCIN, oral; max daily dose reported as 1000 mg) and Placebo 9mm tablet (manufactured by HUS Apteekki).-controlled Phase IV trial across 6 sites in Finland.
- Comparator
- Single cefuroxime (standard prophylaxis) — not specified in CTIS; Azithromycin (product AZITHROMYCIN, oral; max daily dose reported as 1000 mg) and Placebo 9mm tablet (manufactured by HUS Apteekki).
- Target Sample Size
- 2278
- Trial Duration For Participant
- 30
Eligibility
Recruits 2278 No vulnerable populations selected. Participants must understand the information given in Finnish or Swedish..
- Vulnerable Population
- No vulnerable populations selected. Participants must understand the information given in Finnish or Swedish.
Inclusion criteria
- {"criterion_text":"-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
- {"criterion_text":"-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 endpoints
- {"endpoint_text":"-Deep wound and pelvic organ infections up to 30 days postoperatively","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"-Surficial infections and other infections, such has urine tract infections, and fever over 38 ℃ over 2 days.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 2278
- Recruitment Window Months
- 63
- Consent Approach
- Written informed consent obtained from participants. The person must understand the information given in Finnish or Swedish. No assent process or other languages mentioned.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 2278
Finland
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 24-10-2024
- Processing Time Days
- 7
- Number Of Sites
- 6
- Number Of Participants
- 2278
Sites
- Site Name
- Kuopio University Hospital
- Department Name
- Naistentaudit
- Contact Person Name
- Henna Kärkkäinen
- Contact Person Email
- henna.karkkainen@kuh.fi
- Site Name
- Keski-Suomen Hyvinvointialue
- Department Name
- Naistentaudit
- Contact Person Name
- Jaana Seikkula
- Contact Person Email
- jaana.seikkula@hyvaks.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Naistenklinikka
- Contact Person Name
- Päivi Rahkola-Soisalo
- Contact Person Email
- paivi.rahkola-soisalo@hus.fi
- Site Name
- Oulu University Hospital
- Department Name
- Naistentaudit
- Contact Person Name
- Sari Koivurova
- Contact Person Email
- sari.koivurova@ppshp.fi
- Site Name
- Turku University Hospital
- Department Name
- Naistentaudit
- Contact Person Name
- Satu Lunden
- Contact Person Email
- satu.lunden@tyks.fi
- Site Name
- Tampere University Hospital
- Department Name
- Naistentaudit
- Contact Person Name
- Riikka Niemi
- Contact Person Email
- riikka.niemi@pshp.fi
Sponsor
Primary sponsor
- Full Name
- HUS-Yhtymae
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- AZITHROMYCIN
- Active Substance
- AZITHROMYCIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 1000 mg
- Investigational Product Name
- Placebo 9mm tablet, product number 9905609 (Consists of Cellulos.microcrist. (Emcocel 90M); Magn.stear.). Manufactured by HUS Apteekki.
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Combination Treatment
- Yes
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