Research projects
DATA trial
DATA trial
Duration of Antibiotic Treatment Following Amputation: Two versus Fourteen Days of Postoperative Antibiotic Therapy Following Toe Amputation for Diabetic Foot Osteomyelitis
Status: initiation phase
This is a multicenter trial by the Dutch diabetic foot research consortium NVCD
Background
In persons with diabetes, toe amputations for osteomyelitis are commonly performed interventions in Dutch hospitals. The optimal duration of antibiotic therapy for this indication is unknown and typically ranges from 2 days to 14 days. The main objective of this trial is to determine if a short duration of antibiotic therapy (2 days) is non-inferior to a long duration (14 days) of antibiotic therapy, in achieving remission of infection 6 weeks after trans-phalangeal or trans-metatarsal toe amputation for osteomyelitis in persons with diabetes.
Methods
This is an open-label multicentre randomised controlled non-inferiority trial. Both groups receive postoperative antimicrobial therapy. The selection of appropriate antibiotic therapy is according to standard care, based on national guidelines (SWAB) or targeted at previous tissue cultures. Following surgical removal of the infected bone, one group will receive 2 days of antibiotic therapy and a second group will receive 14 days of antibiotic therapy.
Results
Primary endpoint is remission of infection at 6 weeks after amputation. Remission is defined as no need for additional antibiotic therapy or surgery for infection at the original site of amputation. Secondary outcomes at 3 months after amputation are: re-operation for infection at the original amputation site, any additional antibiotic therapy for infection at the original amputation site, survival, amputation, wound healing, hospitalizations, adverse events of antimicrobial therapy and quality of life assessed with SF-12. We assume a remission rate of 90% in both treatment arms.
Conclusion
When we calculate Wald‘s confidence interval without correction for non-inferiority, 156 subjects in total are required to achieve 90% of power at a one-sided significance level of 0.05. With a drop-out rate of 10%, the total number of included subjects will be 174 (87 in each group)
BeBoP Trial
Using a BonE BiOPsy (BeBoP) to determine the causative agent in persons with diabetes and foot osteomyelitis: study protocol for a multicentre, randomised controlled trial
Status: inclusion completed
Background
Diabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy. International guidelines recommend to base antibacterial therapy choices on percutaneous bone biopsy culture, while in practice, therapy is frequently based on (less invasive) ulcer bed cultures. It is currently unknown if treatment outcomes of DFO differ depending on the chosen diagnostic strategy.
Methods
The BeBoP trial is a multicentre; randomised controlled; physician-, researcher- and subject-blinded; clinical trial comparing two diagnostic strategies in persons with DFO. Culture-directed antibacterial therapy will be based on either percutaneous bone biopsy culture results (intervention group) or ulcer bed biopsy culture results (comparison group). We will enrol 80 subjects with diabetes mellitus (≥ 18 years) and DFO, and we will use block randomisation stratified per centre to randomise them in a 1:1 allocation. The primary outcome is remission of DFO 12 months after enrolment. The secondary outcomes are the time to remission, signs of inflammation or ulceration at the primary location of infection at 6 and 12 months, microbiological and molecular profiles of culture outcomes, surgical interventions including amputation, total antibacterial therapy duration, infection-free survival days, adverse events, quality of life and survival. We will compare the outcomes by intention-to-treat and per-protocol analysis.
Discussion
We aim to compare clinical remission in persons with DFO treated with antibacterial therapy based on either percutaneous bone biopsy culture results or ulcer bed biopsy culture results.
Trial registration
Netherlands Trial Register NL 7582. Registered on 05 March 2019
Supplementary Information
The online version contains supplementary material available at 10.1186/s13063-021-05472-6.
CAP study
