2023/05 - Latest news from KCE Trials

This month we will hold our 4th symposium ‘Hot topics and methods in publicly funded clinical trials’ on Thursday 25th May at the Pacheco Centre (Brussels). The scientific programme is available here. We hope to see you there as more than 160 participants have already registered! If you plan to attend, please register before 11th May.

Meanwhile, the proposals in the 2022 investigator led call and the BeNeFIT-3 call are making their way through an extensive selection process. First decisions are expected in June 2022 for the Belgian call and in March 2024 for the BeNeFIT-3 call.

Investigators looking for funding for great RCT ideas should watch the 2023 investigator-led call which will open on 23rd May.

We are also pleased to announce that the results of the International studies SafeBoosc III (cerebral oximetry monitoring in extremely preterm infants) and BeNeDuctus (Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus) have both been recently published in NEJM (see publication section).

KCE Trials team

Funding Opportunities

CALL 2023 Investigator-led will open on 23rd May

Our 8th national investigator-led call for proposals will open in May 2023 and will have a very similar scope and eligibility criteria to the 2022 call. Funding can be requested to set up a study in Belgium OR to recruit Belgium patients in in an international study that fits our scope.

The call will open on May 23rd and will close on September 26th 2023.

All information necessary to apply will be published on the call webpage.

Progress in funded studies

We are happy to announce the following important milestones have been reached in the trials below:

COLBEPCI

Contract signed

The COLbePCI study aims to determine whether a low dose of Colchicine can help patients with coronary artery disease treated with Percutaneous coronary intervention and with at least one additional risk factor. The chief investigator is Dr. Buyschaert from AZ Sint Jan Brugge. AZ St Jan and UZ Gent are co-sponsors of the study. 2770 participants will be randomised in 18 sites in Belgium. The study will last 4 years.

PRIORI

FPI

First patient In has been achieved for the PRIORI study, which recruits pregnant women, with a history of preterm birth, in their first trimester of pregnancy to start with synbiotics or placebo. The study will investigate the effect of synbiotics on the vaginal flora and on the pregnancy duration. The chief investigator is Dr Van Holsbeke from ZOL. 402 participants will be recruited from 12 hospitals.

PRIMALung

FPI

First Patient In has been achieved in the PRIMALung study, in patients with small-cell lung cancer. The study aims to show that survival with brain MRI surveillance alone is not worse than with brain MRI surveillance combined with prophylactic cranial irradiation (PCI) i.e. that in keeping brain irradiation for cases of metastasis, that MRI surveillance is at least as effective as PCI but with less neurological deterioration. This is an international study led by the EORTC. The national coordinator is Prof T Berghmans from Institut Jules Bordet. The study plans to enrol 61 patients in 5 sites in Belgium, contributing to the 600 participants planned in Europe.

BONANZA

FPI

First Patient In has been achieved in the BONANZA study. The study aims to determine whether a neuro-intensive care management protocol guided by continuous PbtO2 monitoring compared to standard care using ICP monitoring alone increases independent functional and neurological outcomes at 6-months in patients with severe traumatic brain injury.

This is an international study led by the ANZICS group (Australian and New Zealand Intensive Care Society) and in Belgium coordinated by Hôpital Erasme. Unfortunately due to a worldwide problem with the provision of PbtO2 probes, the initiation of study sites in Belgium has been temporarily put on hold.

PRECISE

Recruitment complete

Recruitment is complete (935 patients) for the PRECISE study, investigating whether giving more protein than usual in patients admitted to intensive care can reduce muscle breakdown and speed up recovery. This study is part of the BeNeFit-1 call and is a collaboration between Maastricht UMC and Ziekenhuis Oost-Limburg (ZOL) in Genk. Prof Dieter Mesotten is the Coordinating Investigator for Belgium.

The KCE Trials complete portfolio comprises 51 studies. more info>>

Impact

The latest scientific publications are presented below, and links to all publications can be found on the last tab of our dynamic dashboards.

NEW Results Big Bird qualitative study	April 2023	JMIR Form Res	Implementing Blended Care to Discontinue Benzodiazepine Receptor Agonist Use for Insomnia: Process Evaluation of a Pragmatic Cluster Randomized Controlled Trial
NEW Results PELICAN	April 2023	Pain Research and Manage	Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study
NEW Results SafeBoosc	April 2023	NEJM	Cerebral Oximetry Monitoring in ExtremelyPreterm Infants
Results BeNeDuctus	March 2023	NEJM	Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus
Results Big Bird	2022	Sleep	Blended care to discontinue BZRA use in patients with chronic insomnia disorder: a pragmatic cluster randomized controlled trial in primary care
Results ADVOR	2022	NEJM	Acetazolamide in Acute Decompensated Heart Failure with Volume Overload