Dataset Information

Treatment of acute bacterial skin and skin structure infection with single-dose dalbavancin in persons who inject drugs.

ABSTRACT: Background:Persons who inject drugs (PWID) are at increased risk of acute bacterial skin and skin structure infections (ABSSSIs), a growing healthcare concern. Multiple medical, social, and economic issues, including adherence and comorbidities, complicate the medical care of the PWID population, adversely affecting patient outcomes. Methods:We assessed demographics and outcomes for the PWID population in a double-blind trial of 698 patients randomized to dalbavancin 1500 mg as a single intravenous (IV) infusion or as a 2-dose regimen (1000 mg IV on day 1; 500 mg IV on day 8) for ABSSSI. The primary endpoint was ?20% reduction in erythema at 48-72 hours in the intent-to-treat population; clinical status was also assessed at days 14 and 28. Results:There were 212/698 (30.4%) patients with a history of injection drug use in this clinical trial. Dalbavancin efficacy was similar between the single- and 2-dose therapy groups in the PWID and non-PWID populations at all timepoints. Dalbavancin was well tolerated in the PWID population, with similar rates of adverse events as the non-PWID population. Conclusion:Dalbavancin as a single-dose or 2-dose regimen had similar efficacy for the treatment of ABSSSI at all timepoints in the PWID and non-PWID populations. A single 30-minute IV infusion would eliminate the need for indwelling IV access. The convenience of a single dose supervised in a health setting may also optimize treatment adherence in the PWID population.

SUBMITTER: Gonzalez PL

PROVIDER: S-EPMC6292452 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Treatment of acute bacterial skin and skin structure infection with single-dose dalbavancin in persons who inject drugs.

Gonzalez Pedro Luis PL Rappo Urania U Akinapelli Karthik K McGregor Jennifer S JS Puttagunta Sailaja S Dunne Michael W MW

Drugs in context 20181211

<h4>Background</h4>Persons who inject drugs (PWID) are at increased risk of acute bacterial skin and skin structure infections (ABSSSIs), a growing healthcare concern. Multiple medical, social, and economic issues, including adherence and comorbidities, complicate the medical care of the PWID population, adversely affecting patient outcomes.<h4>Methods</h4>We assessed demographics and outcomes for the PWID population in a double-blind trial of 698 patients randomized to dalbavancin 1500 mg as a ...[more]

PMID: 30574170

Similar Datasets

Project description:IntroductionAcute bacterial skin and skin structure infections (ABSSSI) represent one of the most common reasons for emergency department visits, and are frequent complications of intravenous drug use in persons who inject drugs (PWID). This study examined the efficacy and safety of omadacycline, versus linezolid, in PWID and persons who do not inject drugs, in the Phase 3 Omadacycline in Acute Skin and Skin Structure Infection (OASIS-1, OASIS-2) studies.MethodsEligible participants were aged ≥ 18 years with qualifying skin infections: wound infection, cellulitis, erysipelas, or major abscess. The primary efficacy endpoint was early clinical response (ECR) in the modified intent-to-treat (mITT) population, defined as survival with ≥ 20% reduction in lesion size at 48-72 h after the first dose of omadacycline or linezolid. Key secondary endpoints included investigator-assessed clinical response at the post-treatment evaluation (PTE) in the mITT and clinical per-protocol populations, and clinical response at PTE in the micro-mITT population. Safety was assessed based on adverse events (AEs) and standard clinical laboratory tests. Efficacy endpoints of clinical response at ECR and PTE were analyzed for the mITT and clinically evaluable (CE) PTE populations.ResultsIn total, 1380 patients (822 PWID, 558 non-PWID) were included in this secondary analysis. Wound infections were reported more frequently in the PWID subgroup (72.8%) at baseline; cellulitis or erysipelas (43.9%) and major abscess (37.4%) were the most frequently reported baseline infections in the non-PWID subgroup. Clinical success rates at ECR and PTE in the mITT population, and at PTE in the CE population, were high for patients receiving omadacycline or linezolid. Severe or serious treatment-emergent AEs (TEAEs), and TEAEs leading to discontinuation, were infrequent.ConclusionThis subgroup analysis showed that omadacycline was effective and well tolerated, regardless of PWID status.

Project description:BACKGROUND:The rising incidence of infective endocarditis (IE) among people who inject drugs (PWID) has been a major concern across North America. The coincident rise in IE and change of drug preference to hydromorphone controlled-release (CR) among our PWID population in London, Ontario intrigued us to study the details of injection practices leading to IE, which have not been well characterized in literature. METHODS:A case-control study, using one-on-one interviews to understand risk factors and injection practices associated with IE among PWID was conducted. Eligible participants included those who had injected drugs within the last 3?months, were >?18??years old and either never had or were currently admitted for an IE episode. Cases were recruited from the tertiary care centers and controls without IE were recruited from outpatient clinics and addiction clinics in London, Ontario. RESULTS:Thirty three cases (PWID IE+) and 102 controls (PWID but IE-) were interviewed. Multivariable logistic regressions showed that the odds of having IE were 4.65 times higher among females (95% CI 1.85, 12.28; p?=?0.001) and 5.76 times higher among PWID who did not use clean injection equipment from the provincial distribution networks (95% CI 2.37, 14.91; p?<?0.001). Injecting into multiple sites and heating hydromorphone-CR prior to injection were not found to be significantly associated with IE. Hydromorphone-CR was the most commonly injected drug in both groups (90.9% cases; 81.4% controls; p?=?0.197). DISCUSSION:Our study highlights the importance of distributing clean injection materials for IE prevention. Furthermore, our study showcases that females are at higher risk of IE, which is contrary to the reported literature. Gender differences in injection techniques, which may place women at higher risk of IE, require further study. We suspect that the very high prevalence of hydromorphone-CR use made our sample size too small to identify a significant association between its use and IE, which has been established in the literature.

Dataset Information

Treatment of acute bacterial skin and skin structure infection with single-dose dalbavancin in persons who inject drugs.

Publications

Treatment of acute bacterial skin and skin structure infection with single-dose dalbavancin in persons who inject drugs.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets