Post-hysterectomy infections
Conditions
Interventions
Trade Name: AZITHROMYCIN
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AZITHROMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutic
Sponsors
HUS Naistenklinikka
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 700
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: 30 days after the operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No.;Timepoint(s) of evaluation of this end point: No. | — |
Countries
Finland
Contacts
Public ContactNaistenklinikka
HUS Naistenklinikka
Outcome results
None listed