Prospective Trial of a Novel Nomogram to Achieve Updated Vancomycin Trough Concentrations

Purpose. To determine if the use of a novel vancomycin nomogram predicts dosing regimens that achieve target trough concentrations equal to or more accurate than dosing regimens calculated using traditional pharmacokinetic calculations, evaluate the incidence of subtherapeutic and supratherapeutic troughs, and assess pharmacist's impressions of the nomogram.Methods. Prospective, open-label study in 473 patients who had a new order for vancomycin and were >18 years of age and ≤120 kg. Patients were randomized to the active group, dosed using the nomogram, or to the control group, dosed using traditional pharmacokinetic calculations already in place at our institution.Results. Patients dosed via nomogram were within the appropriate trough range in 44% of cases compared to 33% in the control group (P=0.014). Vancomycin troughs less than 10 mcg/mL were significantly decreased with the use of nomogram (P=0.032). Incidence of supratherapeutic troughs, greater than 20 mcg/mL, was not significantly different between groups (P=0.706), and pharmacists agreed that the nomogram was easy to use and saved their time.Conclusions. A novel vancomycin nomogram was prospectively validated and found to be more effective than traditional pharmacokinetic dosing. The nomogram is being implemented as the standard dosing protocol at our institution.

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Rate of complete chemotherapy as planned with comprehensive geriatric assessment guided intervention among vulnerable elderly cancer patients: A randomized-open-label study.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e24021 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e24021-e24021

Author(s):

Manupol Maikami ◽

Napa Parinyanitikul ◽

Nattaya Poovorawan

Keyword(s):

Usual Care ◽

Cancer Patients ◽

Comprehensive Geriatric Assessment ◽

Intervention Group ◽

Control Group ◽

Open Label ◽

Elderly Cancer Patients ◽

Open Label Study ◽

Label Study ◽

Significant Difference

e24021 Background: The Geriatric 8 (G8) is a simplified screening tool to select the appropriate elderly patients for chemotherapy. Vulnerable patients with impaired G8 score might need additional comprehensive geriatric assessment (CGA) with intervention for individual problem. However, the impact of CGA and therapeutic intervention on rate of complete chemotherapy among these patients is rarely addressed. This study aims to evaluate the benefit of CGA guided intervention. Methods: A single center, randomized, open-label study which included newly diagnosed elderly cancer patients (age ≥ 65) with impaired G8 score (≤ 14) who were designated for chemotherapy. After the enrollment, patients were randomized to 1:1 ratio to receive CGA guided intervention (intervention group) or usual care (control group). The primary end point was the rate of complete chemotherapy at 90-day. Associated factors for complete chemotherapy were evaluated. Results: Between June 2019 and December 2019, 52 patients were randomized (26 patients for intervention group and 26 patients for control group). Mean age was 72 years, 59.6% was female, 40.4% had breast cancer and 51.9% had early stage cancer. With G8 assessment, 55.8% had intermediate (score 11-14) and 44.2% had low (score < 11) impaired G8 score. All baseline characteristics were balanced. Using per protocol analysis, there was no significant difference in rate of complete chemotherapy between groups (61.9% vs 50%, OR 1.63; 95%Cl 0.51-5.23; p = 0.42). Considering subgroup analysis in the intermediate G8 score patients, the intervention group had a significant higher rate of complete chemotherapy than control group (81.8% vs 66.7%, OR 2.71; p = 0.02), but no significant difference in low G8 score group (40% vs 27.3%, OR 1.78; p = 0.58). In univariate analysis, age below 75 years, BMI > 20 kg/m2 and intermediate G8 score showed significant factors for improving rate of complete chemotherapy. Conclusions: This is the first study in south-east Asia using CGA and intervention to improve rate of completion in chemotherapy. Although the CGA and intervention had no significant difference but had tendency to be better in completion rate of chemotherapy than usual care. The intermediate-impaired G8 score subgroup is more likely to benefit from CGA guided intervention for complete chemotherapy as planned.

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Effect of personalized wrist orthosis for wrist pain with three-dimensional scanning and printing technique: A preliminary, randomized, controlled, open-label study

Prosthetics and Orthotics International ◽

10.1177/0309364618785725 ◽

2018 ◽

Vol 42 (6) ◽

pp. 636-643 ◽

Cited By ~ 5

Author(s):

Sang Jun Kim ◽

Sung Jae Kim ◽

Yong Ho Cha ◽

Keun Ho Lee ◽

Jeong-Yi Kwon

Keyword(s):

Hand Function ◽

Three Dimensional ◽

Wrist Pain ◽

Control Group ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

High Satisfaction ◽

Significant Difference ◽

Experimental Group

Background: Three-dimensional printer technology can produce the personalized orthosis in various forms. Objective: To develop a personalized wrist orthosis using a three-dimensional scanner and three-dimensional printer for patients with wrist pain. Study design: A preliminary, prospective, randomized, open-label study. Methods: A total of 22 patients with wrist pain were randomly assigned to the control and experimental groups. The control group wore a cock-up orthosis and the experimental group wore a three-dimensional-printed wrist orthosis for 1 week. The Patient-Rated Wrist Evaluation, Jebsen Hand Function Test, and Orthotics and Prosthetics Users’ Survey were checked before and 1 week after the application. Results: The Patient-Rated Wrist Evaluation showed significant pain relief in both groups. Two items of the 28 Orthotics and Prosthetics Users’ Survey questions, “Put toothpaste on brush and brush teeth” and “Dial a touch tone phone,” showed high satisfaction scores, with statistically significant difference in the experimental group ( p = 0.036 and 0.004). Conclusion: The three-dimensional-printed wrist orthosis was superior to the cock-up orthosis for two items of the Orthotics and Prosthetics Users’ Survey. Wrist pain was reduced in the group wearing the three-dimensional-printed wrist orthosis as well as the group wearing the cock-up orthosis, so the three-dimensional-printed wrist orthosis could possibly play the same role as the cock-up orthosis. Clinical relevance A three-dimensional-printed wrist orthosis can be a substitute for a conventional ready-made wrist orthosis for patients with wrist pain with more satisfaction.

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An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model

Malaria Journal ◽

10.1186/s12936-020-03409-z ◽

2020 ◽

Vol 19 (1) ◽

Author(s):

Jeffrey Livezey ◽

Patrick Twomey ◽

Meshell Morrison ◽

Susan Cicatelli ◽

Elizabeth H. Duncan ◽

...

Keyword(s):

Plasmodium Falciparum ◽

High Rate ◽

Control Group ◽

Infection Model ◽

Post Challenge ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Malaria Chemoprophylaxis ◽

To Receive

Abstract Background Malaria remains the top infectious disease threat facing the U.S. military in many forward operating environments. Compliance with malaria chemoprophylaxis remains a critical component in preventing malaria in the deployed Service Member. Studies of previous military operations show that compliance is consistently higher with weekly versus daily dosing regimens. Current FDA approved weekly chemoprophylaxis options have contraindications that can limit prescribing. The combination of chloroquine (CQ) with azithromycin (AZ) has previously been shown to be an efficacious treatment option for malaria, has pharmacokinetics compatible with weekly dosing, and has shown synergy when combined in vitro. Methods In this open label study, 18 healthy volunteers, aged 18–50 years (inclusive), were randomly assigned to receive either 300 mg CQ or 300 mg CQ and 2 gm azithromycin (CQAZ) of directly observed therapy, weekly for 3 weeks prior to undergoing mosquito bite challenge with chloroquine-resistant Plasmodium falciparum. Volunteers that remained asymptomatic and had no evidence of parasitaemia continued to receive weekly post-exposure chemoprophylaxis for 3 weeks following malaria challenge. The primary endpoint was the number of volunteers that remained asymptomatic and had no evidence of parasitaemia 28 days after the malaria challenge. Results All 6 (100%) volunteers randomized to the CQ control group became symptomatic with parasitaemia during the 28-day post-challenge period. Only 1/12 (8.3%) of volunteers in the CQAZ group developed symptoms and parasitaemia during the 28-day post-challenge period. However, after chemoprophylaxis was discontinued an additional 6 volunteers developed parasitaemia between days 28–41 after challenge, with 4 of 6 experiencing symptoms. 80% of subjects in the CQAZ group experienced treatment related gastrointestinal adverse events (including 13% that experienced severe nausea) compared to 38% in the CQ group. A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p = 0.03) and AUC (p = 0.044) levels in those volunteers who never became parasitaemic compared to those who did. Conclusion Given the high rate of side effects and poor efficacy when administered for 3 weeks before and after challenge, the combination of weekly chloroquine and azithromycin is a suboptimal regimen combination for weekly malaria chemoprophylaxis. Trial registration ClinicalTrials.gov NCT03278808

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Igg Food Antibody Guided Elimination-Rotation Diet Was More Effective than FODMAP Diet and Control Diet in the Treatment of Women with Mixed IBS—Results from an Open Label Study

Journal of Clinical Medicine ◽

10.3390/jcm10194317 ◽

2021 ◽

Vol 10 (19) ◽

pp. 4317

Author(s):

Lucyna Ostrowska ◽

Diana Wasiluk ◽

Camille F. J. Lieners ◽

Mirosława Gałęcka ◽

Anna Bartnicka ◽

...

Keyword(s):

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Control Diet ◽

Dietary Treatment ◽

Control Group ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Irritable Bowel ◽

Fodmap Diet

Irritable bowel syndrome (IBS) is a chronic disease with recurrent abdominal pain, disturbed bowel emptying, and changes in stool consistency. We compared the effectiveness of three different dietary treatment plans (G1-FM-low FODMAP diet, G2-IP IgG based elimination-rotation-diet, and as control group, the G3-K control diet recommended by an attending gastroenterologist) in treating patients diagnosed with mixed irritable bowel syndrome. A total of seventy-three female patients diagnosed with a mixed form of irritable bowel syndrome (IBS-M) were enrolled in the study. The diet of each patient in Group 1 (G1-FM) and 2 (G2-IP) was determined individually during a meeting with a dietitian. Patients from Group 3 (G3-K) received nutrition advice from a gastroenterologist. Significant differences in the reduction of IBS symptoms were found between the groups. IBS symptoms as well as comorbid symptoms significantly improved or disappeared completely in the G2-IP group (idiopathic abdominal pain, p < 0.001; abdominal pain after a meal, p < 0.001; abdominal pain during defecation, p = 0.008), while in the G1-FM group, some of the IBS symptoms significantly improved (mucus in stool, p = 0.031; bloating, p < 0.001). In group G3-K no significant improvement was seen. Based on the results of this open-label study, it was concluded that various dietary interventions in the treatment of IBS-M patients do not uniformly affect the course and outcomes of disease management. Rotation diets based on IgG show significantly better results compared to other diets.

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Intralesional Triamcinolone for Fistulous Tracts in Hidradenitis Suppurativa: An Uncontrolled Prospective Trial with Clinical and Ultrasonographic Follow-Up

Dermatology ◽

10.1159/000499934 ◽

2019 ◽

Vol 236 (1) ◽

pp. 46-51 ◽

Cited By ~ 2

Author(s):

Pedro Álvarez ◽

F. Javier García-Martínez ◽

Ines Poveda ◽

José Carlos Pascual

Keyword(s):

Hidradenitis Suppurativa ◽

Single Injection ◽

Small Sample Size ◽

Prospective Trial ◽

Small Sample ◽

Control Group ◽

Open Label ◽

Open Label Study ◽

Lost To Follow Up

Background: There is little evidence on the use of intralesional triamcinolone (ILT) for managing fistulous tracts in hidradenitis suppurativa (HS). Objective: To assess the clinical and ultrasound response to ILT for single fistulous lesions in HS patients. Methods: A prospective open-label study was conducted to assess response to ILT (40 mg/mL) for fistulous tracts in HS. Consecutive patients (Hurley II stage exclusively) presenting to our department were recruited from August 2016 to August 2018. They received a single injection of ILT as the sole treatment. Lesions were assessed clinically and by ultrasound at baseline and 90 days. Results: Of the 53 included HS patients with fistulous tracts, 36 (67.9%) were women, 30 (56.6%) were smokers, and 36 (67.9%) were obese or overweight (body mass index ≥25). Median Sartorius score was 9.0 (IQR 9.0–36.0), and median duration of the lesion treated was 6 months (IQR 3.0–12.0). Fistulous tracts were injected with 0.5 mL triamcinolone 40 mg/mL. Seven patients were lost to follow-up. At 90 days, 20 (43.5%) lesions showed clinical and ultrasound resolution, 13 (28.3%) showed only clinical resolution while persisting on ultrasound, and 13 (28.3%) persisted both clinically and on ultrasound. Mean clinical size decreased from 17.0 to 5.1 mm (p < 0.0001), while mean length on ultrasound decreased from 16.0 to 8.6 mm (p < 0.0001). Limitations: Small sample size and no control group. Conclusions: Our study suggests that ILT is beneficial for small fistulous tracts in HS.

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An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine-resistant Plasmodium falciparum in a controlled human malaria infection model

10.21203/rs.3.rs-37050/v3 ◽

2020 ◽

Author(s):

Jeffrey Livezey ◽

Patrick Twomey ◽

Meshell Morrison ◽

Susan Cicatelli ◽

Elizabeth H Duncan ◽

...

Keyword(s):

Plasmodium Falciparum ◽

High Rate ◽

Control Group ◽

Infection Model ◽

Post Challenge ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Malaria Chemoprophylaxis ◽

To Receive

Abstract BackgroundMalaria remains the top infectious disease threat facing the U.S. military in many forward operating environments. Compliance with malaria chemoprophylaxis remains a critical component in preventing malaria in the deployed Service Member. Studies of previous military operations show that compliance is consistently higher with weekly versus daily dosing regimens. Current FDA approved weekly chemoprophylaxis options have contraindications that can limit prescribing. The combination of chloroquine (CQ) with azithromycin (AZ) has previously been shown to be an efficacious treatment option for malaria, has pharmacokinetics compatible with weekly dosing, and has shown synergy when combined in vitro. MethodsIn this open label study 18 healthy volunteers, aged 18-50 years (inclusive), were randomly assigned to receive either 300 mg CQ or 300 mg CQ and 2 gm azithromycin (CQAZ) of directly observed therapy, weekly for 3 weeks prior to undergoing mosquito bite challenge with chloroquine-resistant Plasmodium falciparum. Volunteers that remained asymptomatic and had no evidence of parasitaemia continued to receive weekly post-exposure chemoprophylaxis for 3 weeks following malaria challenge. The primary endpoint was the number of volunteers that remained asymptomatic and had no evidence of parasitaemia 28 days after the malaria challenge.ResultsAll 6 (100%) volunteers randomized to the CQ control group became symptomatic with parasitaemia during the 28-day post-challenge period. Only 1/12 (8.3%) of volunteers in the CQAZ group developed symptoms and parasitaemia during the 28-day post-challenge period. However, after chemoprophylaxis was discontinued an additional 6 volunteers developed parasitaemia between days 28-41 after challenge, with 4 of 6 experiencing symptoms. 80% of subjects in the CQAZ group experienced treatment related gastrointestinal adverse events (including 13 % that experienced severe nausea) compared to 38% in the CQ group. A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p0.03) and AUC (p0.044) levels in those volunteers who never became parasitaemic compared to those who did. ConclusionGiven the high rate of side effects and poor efficacy when administered for 3 weeks before and after challenge, the combination of weekly chloroquine and azithromycin is a suboptimal regimen combination for weekly malaria chemoprophylaxis.Trial registration: ClinicalTrials.gov NCT03278808

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An Open Label Study of the Safety and Efficacy of a Single Dose of Weekly Chloroquine and Azithromycin Administered for Malaria Prophylaxis in Healthy Adults Challenged with 7G8 Chloroquine-Resistant Plasmodium falciparum in a Controlled Human Malaria Infection (CHMI) Model

10.21203/rs.3.rs-37050/v1 ◽

2020 ◽

Author(s):

Jeffrey Livezey ◽

Patrick Twomey ◽

Meshell Morrison ◽

Susan Cicatelli ◽

Elizabeth H Duncan ◽

...

Keyword(s):

Plasmodium Falciparum ◽

High Rate ◽

Control Group ◽

Directly Observed Therapy ◽

Post Challenge ◽

Open Label ◽

Severe Nausea ◽

Open Label Study ◽

Label Study ◽

To Receive

Abstract Background: Malaria remains the top infectious disease threat facing the U.S. military in many forward operating environments. Compliance with malaria chemoprophylaxis remains a critical component in preventing malaria in the deployed Service Member. Studies of previous military operations show that compliance is consistently higher with weekly versus daily dosing regimens. Current FDA approved weekly chemoprophylaxis options have contraindications that can limit prescribing. The combination of chloroquine (CQ) with azithromycin (AZ) has previously been shown to be an efficacious treatment option for malaria, has pharmacokinetics compatible with weekly dosing, and has shown synergy when combined in vitro. Methods: In this open label study 18 healthy volunteers, aged 18-50 years (inclusive), were randomly assigned to receive either 300 mg CQ or 300 mg CQ and 2 gm azithromycin (CQAZ) of directly observed therapy, weekly for 3 weeks prior to undergoing mosquito bite challenge with chloroquine-resistant Plasmodium falciparum. Volunteers that remained asymptomatic and had no evidence of parasitemia continued to receive weekly post-exposure chemoprophylaxis for 3 weeks following malaria challenge. The primary endpoint was the number of volunteers that remained asymptomatic and had no evidence of parasitemia 28 days after the malaria challenge.Results: All 6 (100%) volunteers randomized to the CQ control group became symptomatic with parasitemia during the 28 day post-challenge period. Only 1/12 (8.3%) of volunteers in the CQAZ group developed symptoms and parasitemia during the 28-day post-challenge period. However, after chemoprophylaxis was discontinued an additional 6 volunteers developed parasitemia between days 28-41 after challenge, with 4 of 6 experiencing symptoms. 80% of subjects in the CQAZ group experienced treatment related gastrointestinal adverse events (including 13 % that experienced severe nausea) compared to 38% in the CQ group. A comparison of the pharmacokinetics in the CQAZ group demonstrated higher azithromycin Cmax (p0.03) and AUC (p0.044) levels in those volunteers who never became parasitemic compared to those who did. Conclusion: Given the high rate of side effects and poor efficacy when administered for 3 weeks before and after challenge, the combination of weekly chloroquine and azithromycin is a suboptimal regimen combination for weekly malaria chemoprophylaxis.Trial registration: ClinicalTrials.gov NCT03278808

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Effect of Dietary Modification for Targeting Histamine Activity in Patients of Allergic Rhinitis: a Randomised Open Label Study

10.21203/rs.3.rs-25717/v1 ◽

2020 ◽

Author(s):

Mohsin Ali Khan ◽

Zaw Ali Khan ◽

Abdul Naeem ◽

Nigar Naqvi ◽

Shikha Srivast ◽

...

Keyword(s):

Allergic Rhinitis ◽

Cell Activation ◽

Standard Treatment ◽

Immunoglobulin E ◽

Mast Cell Activation ◽

Dietary Modification ◽

Control Group ◽

Open Label ◽

Open Label Study ◽

Label Study

Abstract Allergic Rhinitis refers to immunoglobulin E mediated inflammation of the nasal cavity. Mast cell activation releases histamine, the inflammatory mediator that plays a central role in the biochemical mechanism of this disease. It is metabolised by Diamine Oxidase (DAO) and Histamine N-methyltransferase (HNMT). In this randomised open label study, we recruited 60 patients out of which 30 patients were provided standard treatment and 30 were provided standard treatment along with instructions for dietary modification. The dietary modification consisted of excluding commonly consumed histamine-rich foods and foods containing pro-histamine or anti-DAO active constituents. Each patient was followed up 3 times over the course of 15 days. The patients in the dietary modification group showed significant improvement in rhinitis symptoms within 7 days, while the control group’s improvement was not significant in the same amount of time. The overall improvement between the first and last visits was more significant in the dietary modification group as compared to the control group. Thus, the exclusion of histamine-rich foods and foods containing pro-histamine or anti-DAO compounds may be recommended to patients of allergic rhinitis for quicker and better recovery. This approach may also be explored in other conditions where histamine is implicated such as asthma and infections caused by coronaviruses.

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Bromhexine Hydrochloride Prophylaxis of COVID-19 for Medical Personnel: A Randomized Open-Label Study

10.1101/2021.03.03.21252855 ◽

2021 ◽

Author(s):

Evgeny N. Mikhaylov ◽

Tamara A. Lyubimtseva ◽

Aleksandr D. Vakhrushev ◽

Dmitry Stepanov ◽

Dmitry S. Lebedev ◽

...

Keyword(s):

Treatment Group ◽

Primary Endpoint ◽

Medical Staff ◽

Control Group ◽

Nasopharyngeal Swab ◽

Open Label ◽

Symptomatic Infection ◽

Open Label Study ◽

Label Study ◽

Pcr Test

ABSTRACTBackgroundBromhexine hydrochloride has been suggested as a TMPRSS2 protease blocker that precludes the penetration of the SARS-CoV-2 into cells. We aimed to assess the preventive potential of regular bromhexine hydrochloride intake for COVID-19 risk reduction in medical staff actively involved in the evaluation and treatment of patients with confirmed or suspected SARS-CoV-2 infection.MethodsIn a single-center randomized open-label study medical staff managing patients with suspected and confirmed COVID-19 were enrolled and followed-up for 8 weeks. The study began at the initiation of COVID-19 management in the clinic. We enrolled 50 participants without a history of SARS-CoV-2 infection: 25 were assigned to bromhexine hydrochloride treatment (8 mg 3 times per day), and 25 were controls. The composite primary endpoint was a positive nasopharyngeal swab polymerase chain reaction (PCR) test to SARS-CoV-2 or the signs of clinical infection within 28 days and at week 8. Secondary endpoints included the symptomatic infection rate and positive nasopharyngeal swab (PCR) tests.ResultsThe rate of the combined primary endpoint did not differ significantly between the active treatment group (2/25 [8%]) and control group (7/25 [28%]); P = 0.07. A fewer number of participants developed symptomatic infection (confirmed COVID-19) in the treatment group compared to controls (0/25 vs 5/25; P = 0.02).ConclusionBromhexine hydrochloride prophylaxis was associated with a reduced rate of symptomatic COVID-19. However, the prophylactic treatment was not associated with a lower combined primary endpoint rate, a positive swab PCR test and/or COVID-19. (ClinicalTrials.gov number, NCT04405999)

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