Proactive Therapeutic Drug MONiToring to Guide Suppressive Antibiotic Therapy with DALBAvaNcin ( > 12 weeks) in Osteoarticular Infections (MONTALBANO)
<p><strong>Introduction</strong>: Long-term dalbavancin use is increasingly adopted off-label for osteoarticular infections (OAIs), but data on administration timing and long-term effects beyond 12 weeks are scarce. This study evaluated the pharmacological efficacy of proactive the...
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| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Copernicus Publications
2025-07-01
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| Series: | Journal of Bone and Joint Infection |
| Online Access: | https://jbji.copernicus.org/articles/10/255/2025/jbji-10-255-2025.pdf |
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| Summary: | <p><strong>Introduction</strong>: Long-term dalbavancin use is increasingly adopted off-label for osteoarticular infections (OAIs), but data on administration timing and long-term effects beyond 12 weeks are scarce. This study evaluated the pharmacological efficacy of proactive therapeutic drug monitoring (TDM) to optimize dalbavancin administration. <strong>Methods</strong>: This single-center, retrospective study included adult OAI patients treated with <span class="inline-formula">≥4</span> doses of dalbavancin from July 2022 to October 2024. Initial doses were given on days 1, 8, and 43. From the third dose onward, <span class="inline-formula"><i>C</i><sub>min</sub></span> and <span class="inline-formula"><i>C</i><sub>max</sub></span> values informed dosing schedules via log-linear regression models, targeting <span class="inline-formula"><math xmlns="http://www.w3.org/1998/Math/MathML" id="M5" display="inline" overflow="scroll" dspmath="mathml"><mrow><msub><mi>C</mi><mo>min</mo></msub><mo>≥</mo><mn mathvariant="normal">8</mn></mrow></math><span><svg:svg xmlns:svg="http://www.w3.org/2000/svg" width="42pt" height="12pt" class="svg-formula" dspmath="mathimg" md5hash="b9ec776a5854d6989e1ed213b0e00088"><svg:image xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="jbji-10-255-2025-ie00001.svg" width="42pt" height="12pt" src="jbji-10-255-2025-ie00001.png"/></svg:svg></span></span> mg L<span class="inline-formula"><sup>−1</sup></span>. The primary outcome was the pharmacological efficacy of dalbavancin, assessed by the proportion of patients with <span class="inline-formula"><math xmlns="http://www.w3.org/1998/Math/MathML" id="M7" display="inline" overflow="scroll" dspmath="mathml"><mrow><msub><mi>C</mi><mo>min</mo></msub><mo>≥</mo><mn mathvariant="normal">8</mn></mrow></math><span><svg:svg xmlns:svg="http://www.w3.org/2000/svg" width="42pt" height="12pt" class="svg-formula" dspmath="mathimg" md5hash="540ccb64df225d3f43ae00b1d49e893a"><svg:image xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="jbji-10-255-2025-ie00002.svg" width="42pt" height="12pt" src="jbji-10-255-2025-ie00002.png"/></svg:svg></span></span> mg L<span class="inline-formula"><sup>−1</sup></span> and <span class="inline-formula">≥4</span> mg L<span class="inline-formula"><sup>−1</sup></span> after the third dose. Clinical outcomes and safety data were collected as descriptive data. <strong>Results</strong>: A total of 33 patients provided 118 <span class="inline-formula"><i>C</i><sub>min</sub></span> determinations. Pharmacological efficacy was achieved in 93<span class="inline-formula"><math xmlns="http://www.w3.org/1998/Math/MathML" id="M12" display="inline" overflow="scroll" dspmath="mathml"><mo>/</mo></math><span><svg:svg xmlns:svg="http://www.w3.org/2000/svg" width="8pt" height="14pt" class="svg-formula" dspmath="mathimg" md5hash="6bfc4ae3491d603d986b6e1d0e6866cf"><svg:image xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="jbji-10-255-2025-ie00003.svg" width="8pt" height="14pt" src="jbji-10-255-2025-ie00003.png"/></svg:svg></span></span>118 (78.8 %) and 114<span class="inline-formula"><math xmlns="http://www.w3.org/1998/Math/MathML" id="M13" display="inline" overflow="scroll" dspmath="mathml"><mo>/</mo></math><span><svg:svg xmlns:svg="http://www.w3.org/2000/svg" width="8pt" height="14pt" class="svg-formula" dspmath="mathimg" md5hash="8550e2e9970f84100ffbfa4da4f4f543"><svg:image xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="jbji-10-255-2025-ie00004.svg" width="8pt" height="14pt" src="jbji-10-255-2025-ie00004.png"/></svg:svg></span></span>118 (96.6 %) determinations for <span class="inline-formula"><i>C</i><sub>min</sub></span> thresholds of <span class="inline-formula">≥8</span> mg L<span class="inline-formula"><sup>−1</sup></span> and <span class="inline-formula">≥4</span> mg L<span class="inline-formula"><sup>−1</sup></span>, respectively. Efficacy improved when considering only determinations at the correct timing. A total of 18 (54.5 %) patients are still in treatment, while 11 (33.3 %) completed therapy with clinical success. Three patients experienced a relapse after the end of the treatment, while one patient experienced failure, and no adverse events were reported. <strong>Conclusions</strong>: Dalbavancin is a viable option for prolonged OAI management when other therapies are unavailable or high-risk. Proactive TDM effectively supports this approach by ensuring adequate drug exposure while preventing accumulation.</p> |
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| ISSN: | 2206-3552 |