A Randomized, Placebo-Controlled Study on Prophylactic Azithromycin and Cefuroxime Versus Cefuroxime Alone for Post-Hysterectomy Infection Prevention

The primary objective of this study is to evaluate **post-hysterectomy infections** and to compare the efficacy of prophylactic use of **azithromycin** and **cefuroxime** versus single cefuroxime administration. This comparison is clinically relevant as it aims to determine the most effective antibiotic prophylaxis strategy to reduce the incidence of infections following a hysterectomy, a common surgical procedure. The study does not list any secondary objectives.

The clinical trial focuses on **women undergoing hysterectomy** for benign indications, specifically in a public hospital setting in Finland. The study population is exclusively female, with an age range corresponding to categories 3 and 4, which typically includes adults and middle-aged individuals. Participants are required to have no contraindications for the use of azithromycin or cefuroxime, and they must be able to comprehend information provided in Finnish or Swedish. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria emphasize the general health status of the participants, ensuring they are suitable for the study's objective of comparing antibiotic prophylaxis methods. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **azithromycin** and cefuroxime in preventing post-hysterectomy infections compared to cefuroxime alone. This study is a randomized, double-blind, placebo-controlled trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thus minimizing bias. The trial is expected to run from September 5, 2022, to December 31, 2027, with the primary objective of assessing deep wound and pelvic organ infections up to 30 days postoperatively. Secondary endpoints include the evaluation of surficial infections, urinary tract infections, and fever exceeding 38°C for more than two days.

Participants will be women undergoing hysterectomy for benign indications in a public hospital in Finland, who do not have contraindications for the study drugs and can understand Finnish or Swedish. The trial will begin with a screening visit to confirm eligibility based on the inclusion criteria. Following randomization, participants will receive either the active treatment or placebo orally. The study involves multiple follow-up visits to monitor the participants' health and collect data on infection rates and any adverse events. The end-of-study visit will conclude the trial for each participant, ensuring all necessary data is collected and any remaining health concerns are addressed.

The expected duration of participant involvement is approximately one month, aligning with the primary endpoint of assessing infections up to 30 days postoperatively. Conditions that may lead to early termination from the study include the development of severe adverse reactions to the study drugs or withdrawal of consent by the participant. The trial's methodology and design are structured to provide robust data on the effectiveness of the antibiotic regimen in preventing infections following hysterectomy, contributing valuable insights to clinical practice.

The clinical trial involves the administration of **AZITHROMYCIN**, an antibiotic used for prophylactic purposes in the study of post-hysterectomy infections. The pharmaceutical form of AZITHROMYCIN is identified as PHF00230MIG, and it is administered orally. The maximum daily dose is 1000 mg, with the same amount being the maximum total dose allowed. The treatment period is limited to one day. AZITHROMYCIN is classified under the ATC code J01FA10, indicating its role as a macrolide antibiotic. The active substance is of chemical origin, and the product is not formulated for pediatric use.

The study also includes a **placebo** as a comparator treatment. The placebo is a 9mm tablet, identified by product number 9905609, and consists of microcrystalline cellulose (Emcocel 90M) and magnesium stearate. It is manufactured by HUS Apteekki. The placebo is administered orally, with a maximum daily and total dose of one tablet, and the treatment period is also limited to one day. The placebo serves as a control to evaluate the efficacy of the antibiotic regimen in preventing infections post-hysterectomy.

The efficacy of the clinical trial titled "Infections after hysterectomy - a placebo controlled study comparing the prophylactic use of azithromycin and cefuroxime with single cefuroxime" will be assessed using specific primary and secondary endpoints. The primary endpoint is the occurrence of deep wound and pelvic organ infections up to 30 days postoperatively. Secondary endpoints include the incidence of surficial infections, other infections such as urinary tract infections, and fever exceeding 38°C for more than two days.

Data collection will occur at specified timepoints, with a focus on the postoperative period extending to 30 days. The analysis will involve comparing the incidence rates of these infections between the treatment groups receiving **azithromycin** and cefuroxime versus those receiving only cefuroxime. The trial aims to provide insights into the efficacy of combined antibiotic prophylaxis in reducing postoperative infections following hysterectomy.