Adnexal torsion is a gynaecological emergency in which prompt diagnosis and management are critical to preserving ovarian function. However, the clinical presentation is often non-specific, and diagnosis primarily relies on pelvic ultrasound, a modality with limited sensitivity that can lead to misdiagnosis and unnecessary surgery. Contrast-enhanced ultrasound (CEUS) has emerged as a promising imaging technique that may enhance diagnostic accuracy by better characterising adnexal vascularisation.

The aim of this study is to assess whether the addition of CEUS to standard diagnostic procedures can reduce the rate of unnecessary emergency surgeries. Specifically, we compare two diagnostic strategies in cases of high clinical suspicion of adnexal torsion: the current standard approach versus an experimental strategy incorporating CEUS. The primary outcome is the rate of inappropriate surgical interventions, defined as emergency surgery performed within 6 hours without intraoperative confirmation of torsion.

This is a prospective, open-label, multicentre, randomised (1:1), controlled, superiority trial. A total of 256 women presenting with a high clinical suspicion of adnexal torsion will be enrolled over a period of 36 months. Participants will be randomly assigned to either the standard diagnostic strategy or an experimental strategy that includes CEUS. The primary endpoint is the proportion of emergency surgical procedures (performed within 6 hours of hospital admission) in which adnexal torsion is not confirmed.

The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) on 28 October 2024. The results of this study will be published in peer-reviewed journals and presented at relevant national and international conferences. The ethical approval number from the CPP is 6115.

NCT06677554; 2024-511720-13-00.

Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.

FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.

The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.

NCT04310930, ANZCTR12618001831279, 2020-000050-10, ISRCTN67303903.