Pharmacokinetic Study of ANAWIDOW [Antivenin Latrodectus (Black Widow) Equine Immune F(ab´)2] Solution 10 mL for Intravenous Use of Laboratorios Silanes, S.A. de C.V. in Healthy Adult Male and Female Subjects Under Fasting Conditions.

A single-dose, open-label, single-treatment, single-period pharmacokinetic study under fasting conditions, in 12 healthy adult. To evaluate the single dose pharmacokinetic profile ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab´)2] lyophilized powder for solution 10 mL (dose: 3x10 mL vials) for intravenous use.

开始日期2021-07-01

申办/合作机构

Laboratorios Silanes SA de CV

[+1]

NCT00657540 / Completed临床3期

A Phase III Multicenter Clinical Trial of Analatro® [Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2] in Patients With Systemic Latrodectism

The purpose of this study is to test the efficacy and safety of a new antivenom called Analatro® for treating black widow spider bites in patients who present to a hospital emergency room within 24 hours of symptom onset. This study will be a phase III, multi-center, double-blind, randomized controlled study that takes place in emergency departments. The primary aim of this study is to determine the proportion of patients in which pain control was not achieved by 48 hours post treatment. Secondary aims are as follows: 1) a reduction in pain intensity at the end of the treatment phase compared to baseline; 2) the proportion of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related adverse events occurred; and 4) to determine if serious, drug-related adverse events in Analatro-treated patients occurred at a rate greater than one in 10 (10%).

开始日期2009-10-01

申办/合作机构

Instituto Bioclon SA de CV

[+1]

NCT00247078 / Completed临床2期

The Efficacy and Safety of Aracmyn® [Antivenin Latrodectus (Black Widow)Equine Immune F(ab)2], in Patients With Systemic Latrodectism: A Phase II, Multi-center, Randomized, Double-Blind Trial

The purpose of this study is to compare the safety and effectiveness of an investigational antivenom and the current standard of care (pain management with opioid analgesics) for treating patients with a widow spider bite. The working hypotheses are as follows:
the investigational antivenom is more promptly effective at alleviating the pain associated with a widow spider bite than routine management with opioid pain medication
the investigational antivenom is as safe a treatment as opioid pain medication in treating patients with a widow spider bite.

开始日期2005-10-01

申办/合作机构

Instituto Bioclon SA de CV

[+1]

100 项与 Latrodectus antivenin 相关的临床结果

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100 项与 Latrodectus antivenin 相关的转化医学

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100 项与 Latrodectus antivenin 相关的专利（医药）

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项与 Latrodectus antivenin 相关的文献（医药）

2024-10-01·Toxicon

Hypersensitivity vs. uncommonly severe local envenoming by the red-back spider, Latrodectus hasselti Thorell, 1870 (Araneae: Theridiidae)

Article

作者: Weinstein, Scott A. ; Weinstein, Scott A

The genus Latrodectus (Araneae: Theridiidae) consists of 35 widow spider species with global distribution. Envenoming by medically important species, latrodectism, commonly features bite site erythema and diaphoresis, variably severe pain that may be persistent, myalgia/cramping and/or myoclonus, autonomic symptoms, abdominal distress; severe envenoming can be prolonged and include serious effects such as oliguria, hypertension and, rarely, myocarditis/myocardial injury. Red-back spiders (Latrodectus hasselti) are the most common cause of envenoming in Australia and can cause the spectrum of effects noted for other medically important widow spiders. A 34-yr-old woman with a history of previous L. hasselti envenoming and treatment with antivenom was envenomed in her left ankle by a verified L. hasselti (hiding in her boot) while attending an appointment with her primary care physician. She reported some of the common effects of latrodectism including severe, prolonged pain, bite site diaphoresis, and malaise; however, she also developed marked edema that involved the entire left foot. She also exhibited mild hypertension and autonomic/non-specific effects limited to nausea, headache, and anxiety. She was effectively treated with red-back spider antivenom (a total of 4 ampoules) and supportive care; full resolution of the edema required almost 5 days. The uncommon clinical evolution of L. hasselti local envenoming observed in this patient may have been caused by a mixed picture of venom-induced effects and Type I hypersensitivity, but alternatively could be a rare, solely venom-induced manifestation. While provision of patient-centred care for anyone envenomed by Latrodectus spp. requires careful history collection and assessment of comorbidities, differentiation of atopic and direct venom effects may be challenging in some envenomed patients with established complex allergy history.

2023-08-01·Emergency Medicine Australasia

Evolution in the choice of therapies used to treat latrodectism: Redback spider antivenom or standard analgesic medications. Nothing to rave about

Article

作者: Graudins, Andis ; Sulaeman, Siba J

AbstractObjectivesRedback spider (RBS) antivenom (RBSAV) use appears to have decreased since the results of the RAVE‐2 antivenom efficacy study were released. The aims of this study were to assess change in RBSAV use over time and compare responses to treatment for antivenom and other analgesics.MethodsRetrospective audit of RBS bite referrals to a toxicology unit, from January 2010 to January 2022. Data included demographics, pain severity, treatment (analgesia or RBSAV), response to treatment, re‐presentation rate, adverse events, change in antivenom use over time.ResultsOf 270 presentations, 157 with moderate or severe pain were included (RBSAV n = 51, analgesia n = 106). Median age was 39 years, n = 81 (51%) female. Those receiving antivenom were more likely to report severe pain n = 46/51 (84%) versus n = 68/106 (58%) (P = 0.006). Eighty‐three percent of antivenom doses were administered between 2010 and 2013. Analgesia‐only group received various combinations of paracetamol, NSAIDs, and opioids. In those receiving RBSAV, 17/48 (35%), 26/48 (54%), 5/48 (10%) reported a partial, complete or no reduction in pain, respectively, versus 30/77 (39%), 43/77 (58%) and 4/77 (5%), for analgesia‐only group. Post‐treatment pain was not recorded in three RBSAV and 28 analgesia‐only patients. Pain reduction was no different for intravenous and intramuscular antivenom. Re‐presentation for ongoing pain was more common in the analgesia‐only group, 16/106 (15%) versus 1/51 (2%) for antivenom (P = 0.013).ConclusionAntivenom use fell over the study period. There was no difference in pain relief between RBSAV and analgesia‐only groups. RBSAV, regardless of route of administration, was no better than standard analgesics in pain reduction in the present study.

2014-12-01·Annals of Emergency Medicine1区 · 医学

Randomized Controlled Trial of Intravenous Antivenom Versus Placebo for Latrodectism: The Second Redback Antivenom Evaluation (RAVE-II) Study

1区 · 医学

Article

作者: Ovidiu Pascu ; Colin B. Page ; Geoffrey K. Isbister ; Stephen P.J. MacDonald ; Leonie A. Calver ; Simon G.A. Brown ; Daniel M. Fatovich ; Nicholas A. Buckley

STUDY OBJECTIVELatrodectism is the most important spider envenomation syndrome worldwide. There remains considerable controversy over antivenom treatment. We aimed to investigate whether antivenom resulted in resolution of pain and systemic effects in patients with latrodectism who received standardized analgesia.METHODSIn a multicenter randomized placebo-controlled trial of redback spider antivenom for latrodectism, 224 patients (>7 years) with a redback spider bite and severe pain, with or without systemic effects, were randomized to receive normal saline solution (placebo) or antivenom after receiving standardized analgesia. The primary outcome was a clinically significant reduction in pain 2 hours after trial medication compared with baseline. A second primary outcome for the subgroup with systemic features of envenomation was resolution of systemic features at 2 hours. Secondary outcomes were improved pain at 4 and 24 hours, resolution of systemic features at 4 hours, administration of opioid analgesics or unblinded antivenom after 2 hours, and adverse reactions.RESULTSTwo hours after treatment, 26 of 112 patients (23%) from the placebo arm had a clinically significant improvement in pain versus 38 of 112 (34%) from the antivenom arm (difference in favor of antivenom 10.7%; 95% confidence interval -1.1% to 22.6%; P=.10). Systemic effects resolved after 2 hours in 9 of 41 patients (22%) in the placebo arm and 9 of 35 (26%) in the antivenom arm (difference 3.8%; 95% confidence interval -15% to 23%; P=.79). There was no significant difference in any secondary outcome between antivenom and placebo. Acute systemic hypersensitivity reactions occurred in 4 of 112 patients (3.6%) receiving antivenom.CONCLUSIONThe addition of antivenom to standardized analgesia in patients with latrodectism did not significantly improve pain or systemic effects.

100 项与 Latrodectus antivenin 相关的药物交易

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