Evaluation of RT-qPCR of mouthwash and buccal swabs for detection of SARS-CoV-2 in children and adults.

BACKGROUND: The use of nasopharyngeal (NP) swabs as a specimen collection method to diagnose SARS-CoV-2 infection is frequently perceived as uncomfortable by patients and requires trained personnel. In this study, detection rate of SARS-CoV-2 in mouthwash samples and buccal swabs were compared in both children and adults. MATERIAL AND METHODS: In patients admitted to hospital with confirmed COVID-19 within the previous 72 hours, NP and buccal swabs as well as mouthwash samples were collected. RT-qPCR was performed on all samples. RESULTS: In total, 170 samples were collected from 155 patients (137 adults and 18 children). Approximately 91.7% of the collected NP swabs were positive in RT-PCR compared to 63.1% of mouthwash samples and 42.4% of buccal swabs. Compared to NP swabs, the sensitivity of using mouthwash was 96.3% and 65.4% for buccal swabs in NP swab samples with a CT value <25. With increasing CT values, sensitivity decreased in both mouthwash and buccal swabs. The virus load was highest during the first week of infection, with a continuous decline observed in all three collection methods over time. DISCUSSION: Mouthwash presents an alternative collection method for detecting SARS-CoV-2 in the case of unfeasible NP swab sampling. Buccal swabs should not be used due to their low sensitivity.

Characterization of the gastrointestinal transit and disintegration behavior of floating and sinking acid-resistant capsules using a novel MRI labeling technique.

The application areas of hard capsules are currently widened by the introduction of acid-resistant capsule shells. In this study, the gastrointestinal behavior of acid-resistant hard capsule formulations as well as the influence of their density on the gastric residence time were characterized using magnetic resonance imaging (MRI). As labeling material for a reliable identification of the capsules in the MR images, small pieces of dried pineapple were used as they provide a high T1 signal. Tested products were DRcaps™ as capsule in capsule (Cap-in-Cap) system (outer capsule size 00). For the investigation of the influence of the capsule density on the gastric residence time, a floating low-density Cap-in-Cap capsule formulation and a sinking high-density Cap-in-Cap capsule formulation were investigated. The study was performed in eight healthy human subjects under fasting conditions. Besides the transit data of the capsule systems, the intraluminal fluid volume kinetics were determined using T2 weighted sequences. The gastric emptying times of the systems did not differ, with mean values of 45 ±â€¯35 min for floating DRcaps™ and 36 ±â€¯18 min for the sinking DRcaps™. The difference in density had no remarkable influence on gastric emptying. Thus, the concept of floating capabilities for gastroretentive dosage forms seems rather implausible. Furthermore, this assures transferability of common knowledge about dosage form transit for estimation of the performance of acid-resistant capsule shells, which most typically float. The mean disintegration times amounted to 139 ±â€¯35 min for the floating DRcaps™ Cap-in-Cap and 163 ±â€¯55 min for the sinking DRcaps™ Cap-in-Cap. In only one case, a sinking DRcaps™ Cap-in-Cap system disintegrated during gastric emptying, but all other capsules disintegrated in the small intestine, irrespective of their gastric residence time. The use of dried pineapple as labeling material could be successfully demonstrated as a reliable and easy method for the tracking of the transit and disintegration behavior of orally administered drug delivery systems, leading to a thorough understanding of their in vivo performance.

Gastric Water Emptying under Fed State Clinical Trial Conditions Is as Fast as under Fasted Conditions.

The Magenstrasse (stomach road) describes the fast emptying of ingested liquids from the postprandial stomach. The occurrence of the Magenstrasse has great importance for drugs administered together with food as it represents a shortcut through the fed stomach and allows rapid onset of plasma levels. In this study, we investigated the effect of different meals and their texture and fat content on the occurrence of the Magenstrasse. Since the administration of water is common 60 min after drug intake in clinical trials, we also investigated the effect of time point of water administration on the Magenstrasse by a second water administration. The texture of solid meals and a higher amount of solid food components turned out to favor the presence of the Magenstrasse. On the other hand, the effect of fat content of the meals was negligible. Additionally, the gastric emptying of water was comparable between the first and the second (60 min later) fluid administration, which could lead to an entrainment of drug substance. So far, the Magenstrasse is proven for water; an investigation of other liquid vehicles might be interesting for further mechanistic understanding and utilization. It turned out that the phenomenon of the Magenstrasse can also occur at later time points in clinical studies and may have great impact on the pharmacokinetic profiles obtained in these studies.

Can on-demand non-sedating antihistamines improve urticaria symptoms? A double-blind, randomized, single-dose study.

Non-sedating H1-antihistamines are the recommended first-line treatment for chronic spontaneous urticaria. While efficacy studies usually apply continuous daily treatment regimens, many patients take their medication on demand. In this randomized, double-blind trial we tested whether on-demand H1-antihistamine desloratadine in standard and higher doses is able to improve the resolution of existing wheals. Symptoms of 29 patients with chronic spontaneous urticaria were followed without treatment on one day and again on another day during the next 3 weeks after a single dose of either 5 mg or 20 mg desloratadine, using different objective measures. While the intervention with both doses of desloratadine was effective in terms of a reduction in hyperthermic skin area, there was no improvement in wheal area and wheal volume compared with no treatment. Wheal numbers were reduced after treatment with 20 mg, but not 5 mg, desloratadine. In conclusion, the beneficial effects of non-sedating H1-anti-histamines given on demand appear to be low. Thus, a preventive treatment strategy should be preferred in chronic spontaneous urticaria.

Rupatadine and its effects on symptom control, stimulation time, and temperature thresholds in patients with acquired cold urticaria.

BACKGROUND: Patients with acquired cold urticaria (ACU) show itchy wheals during cold exposure. This disturbing condition involves histamine and platelet-activating factor in its pathogenesis. Rupatadine is a dual antagonist of both histamine and platelet-activating factor. OBJECTIVE: To assess rupatadine efficacy in preventing reactions to cold challenge in patients with ACU. METHODS: A crossover, randomized, double-blind, placebo-controlled study in which 21 patients with ACU received rupatadine, 20 mg/d, or placebo for 1 week each is presented. The main outcome was the critical stimulation time threshold (CSTT) determined by ice cube challenge. Secondary outcomes included CSTT and the critical temperature threshold assessed by a cold provocation device (TempTest 3.0), as well as scores for wheal reactions, pruritus, burning sensations, and subjective complaints after cold challenge. RESULTS: After rupatadine treatment, 11 (52%) of 21 patients exhibited a complete response (ie, no urticaria lesions after ice cube provocation). A significant improvement in CSTT compared with placebo was observed after ice cube and TempTest 3.0 challenge (P = .03 and P = .004, respectively). A significant reduction of critical temperature threshold (P < .001) and reduced scores for cold provocation-induced wheal reactions (P = .01), pruritus (P = .005), burning sensation (P = .03), and subjective complaints (P = .03) after rupatadine treatment were also found. Mild fatigue (n = 4), somnolence (n = 1), and moderate headache (n = 1) were reported during active treatment. CONCLUSION: Rupatadine, 20 mg/d, shows high efficacy and is well tolerated in the treatment of ACU symptoms.

Cutting-balloon angioplasty effectively facilitates the interventional procedure and leads to a low rate of recurrent stenosis in ostial bifurcation coronary lesions: A subgroup analysis of the NICECUT multicenter registry.

BACKGROUND: Displacement of plaque is a major concern during coronary intervention of ostial bifurcation lesions. For this reason, angioplasty involves complex stenting procedures, which may trigger development of restenosis in a previously non-diseased parent vessel. OBJECTIVES: To examine, whether plaque displacement may be prevented by scoring atherosclerotic plaque with a cutting-balloon (CB) stand-alone procedure. METHODS: Data of patients with Duke E and B type ostial bifurcation lesions (>/=70% stenosis involving a diagonal and/or marginal branch >2 mm deriving from a non-diseased parent vessel), who were treated with CB as stand-alone procedure within the prospective NICECUT multicenter trial were analyzed. Primary endpoint was the rate of binary stenosis and target lesion revascularization (TLR). Secondary endpoints were procedural success and major adverse cardiac events (MACE) at 6-months follow-up. RESULTS: 63 out of 65 lesions (56 patients) were successfully amenable to treatment with CB (96.4% procedural success). 76.9% of patients were successfully treated with CB as a stand-alone procedure, while provisional stenting was necessary in 23.1%. At follow-up, binary stenosis was found in 23.2%, among the total population. Total rate of TLR and MACE were 7.7% and 3.6%, respectively, compared to 4.0% and 2.0% in patients for whom CB stand-alone procedure was feasible, while it was 20.0% and 6.7% for stented lesions. CONCLUSIONS: CB angioplasty as a stand-alone procedure may facilitate interventional treatment of ostial bifurcation lesions and may help to avoid complex stenting procedures. It is associated with a low rate of binary stenosis and TLR.