E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-hysterectomy infections |
|
E.1.1.1 | Medical condition in easily understood language |
Post-hysterectomy infections |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary outcome of the study is to assess whether azithromycin + cefuroxime decreases post-hysterectomy deep infections (wound infections beneath fascia + deep pelvic area infections) as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. |
|
E.2.2 | Secondary objectives of the trial |
Secondary outcomes are to assess whether azithromycin + cefuroxime decreases post-hysterectomy superficial infections, urinary tract infections, or post-operative fever as compared to cefuroxime only, and to report possible side-effects of the used antibiotics.
In addition, the study finds out a possible role of BV and microbiome in post-hysterectomy infections. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
|
E.4 | Principal exclusion criteria |
Inability to understand the study protocol.
Allergy for either cefuroxime or azithromycin.
Congenital or acquired prolonged QTc interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family.
ECG will be checked for all the participants.
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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
All infection episodes will be reported up to 30 days postoperatively:
1. Deep wound and pelvic organ infections
2. Surficial infections
3. Other infections, such has urine tract infections, fever over 38 ℃ over 2 days. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after the operation. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
30 days postoperatively. A longer period if there is a condition that has occurred in 30 days but the treatment is ongoing beyond 30 days postoperatively. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |