scholarly journals Does additional antimicrobial treatment have a better effect on URTI cough resolution than homeopathic symptomatic therapy alone? A real-life preliminary observational study in a pediatric population

2015 ◽  
Vol 10 ◽  
Author(s):  
Alessandro Zanasi ◽  
Salvatore Cazzato ◽  
Massimiliano Mazzolini ◽  
Carla Maria Sofia Ierna ◽  
Marianna Mastroroberto ◽  
...  
Keyword(s):  
Observational Study ◽  
Antibiotic Treatment ◽  
Pediatric Population ◽  
Adult Population ◽  
Randomized Study ◽  
Real Life ◽  
Symptomatic Therapy ◽  
Oral Antibiotic ◽  
Acute Cough ◽  
Double Blind

Background. The effectiveness of a homeopathic syrup on cough has been demonstrated in an adult population in a previous double-blind randomized study. The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. Objectives. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Methods. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Results. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020). Conclusions. Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.

scholarly journals Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study

Pharmaceutics ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 1721
Author(s):  
Thibault Vallet ◽  
Yahya Bensouda ◽  
Jumpei Saito ◽  
Liv Mathiesen ◽  
Varsha Pokharkar ◽  
...  
Keyword(s):  
Observational Study ◽  
Real Life ◽  
Active Pharmaceutical Ingredient ◽  
Target Population ◽  
Resistant Bacteria ◽  
Oral Antibiotic ◽  
Multivariate Approach ◽  
Oral Antibiotics ◽  
Reference Framework ◽  
The Many

Antibiotics are among the most commonly prescribed drugs in children. Adherence to the treatment with these drugs is of the utmost importance to prevent the emergence of resistant bacteria, a global health threat. In children, medicine acceptability is likely to have a significant impact on compliance. Herein we used a multivariate approach, considering simultaneously the many aspects of acceptability to explore the drivers of oral antibiotic acceptability in children under twelve, especially in toddlers and in preschoolers. Based on 628 real-life observer reports of the intake of 133 distinct medicines, the acceptability reference framework highlighted the influence of many factors such as age and sex of patients, previous exposure to treatment, place of administration, administration device, flavor agent in excipients and active pharmaceutical ingredient. These findings from an international observational study emphasize the multidimensional nature of acceptability. Therefore, it is crucial to consider all these different aspects for assessing this multi-faceted concept and designing or prescribing a medicine in order to reach adequate acceptability in the target population.

scholarly journals Clinical evaluation of the synbiotic Prodefen Plus® in the prevention of the antibiotic-associated diarrhoea in subjects requiring antibiotic treatment

2020 ◽  
Vol 11 (6) ◽  
pp. 535-545
Author(s):  
C. Barreiro Guridi ◽  
A. Romeo Serena ◽  
S. Gallego Cabrera ◽  
I. Alaman Fernández ◽  
C. Royo Hernández ◽  
...  
Keyword(s):  
Antibiotic Treatment ◽  
Adult Population ◽  
Supportive Therapy ◽  
Food Supplement ◽  
Active Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Group A ◽  
Antibiotic Associated Diarrhoea ◽  
Dietary Food

Prodefen® is a dietary food supplement formulated as a synbiotic that has shown additional benefit to the standard supportive therapy in the management of acute viral diarrhoea in children. There is scarce evidence of this synbiotic in adults. The objective of this randomised double blind placebo-controlled clinical trial was to evaluate the efficacy and safety of Prodefen Plus® in the prevention of antibiotic-associated diarrhoea (AAD) in an adult population requiring either antibiotic treatment for an oral infection or antibiotic prophylaxis for a dental surgical procedure in a dental consultation. 151 subjects were randomised to the active (synbiotic) or control arm (placebo) for 14 days. There was a significantly higher reduction in the AAD incidence, and an improvement in the stool consistency in the active group. A higher reduction in both the frequency and duration of the diarrhoea episodes in the active group was also observed, as it was an improved perception of the diarrhoea severity. Overall, the study medication was well tolerated. In conclusion, results from this study confirm the beneficial effect of the synbiotic administered as adjuvant therapy in preventing the antibiotic-associated diarrhoea.

Safety, pharmacokinetics, and efficacy of palonosetron in pediatric patients: A multicenter, stratified, double-blind, phase 3, randomized study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9570-9570 ◽  
Author(s):  
R. Kadota ◽  
V. Shen ◽  
Y. Messinger
Keyword(s):  
Total Dose ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
Randomized Study ◽  
Plasma Concentrations ◽  
Laboratory Data ◽  
Group Analysis ◽  
Systemic Exposure ◽  
Double Blind ◽  
Age Related

9570 Background: A single intravenous (IV) dose of palonosetron (PALO) 0.25 mg is used in the prevention of acute chemotherapy-induced nausea and vomiting (CINV) after highly (HEC) and moderately emetogenic chemotherapy (MEC) and in the prevention of delayed CINV after MEC. Since younger age is a risk factor that increases the likelihood of CINV, we conducted this study to explore the safety, pharmacokinetics (PK) and efficacy of PALO in pediatric patients receiving MEC (32% of patients) or HEC (68%). Methods: Sixty pediatric patients in 2 age strata, ages 2–11 and 12–17 years, were randomized to receive a single IV dose of PALO 3 mcg/kg (max total dose = 0.25 mg) or 10 mcg/kg (max total dose = 0.75 mg), with no concomitant antiemetics prior to MEC or HEC. The same doses were used in 12 additional younger patients (age range: 28 days - 23 months) treated in an open-label fashion. Safety, assessed as incidence of adverse events (AEs), was the primary between-group analysis endpoint. Plasma concentrations, PK parameters and efficacy (up to 24 hours after chemotherapy) were assessed descriptively for both PALO doses in each age group. Results: Only 3 AEs, 2 (pyrexia and pruritus) in the 3 mcg/kg dose group (5.7%) and 1 (pain) in the 10 mcg/kg group (2.7%), were judged possibly related to study medication by the investigators, and none of them were severe or led to study discontinuation. No cardiac safety issues were identified; vital signs and laboratory data did not raise any safety concerns for the administration of either dose of PALO. Systemic exposure (AUC) to PALO increased with increasing dose across all age groups (AUC0–8: 22.17–33.25 ng*h/mL at 3 mcg/kg dose; 49.85–75.1 ng*h/mL at 10 mcg/kg dose). Clearance and volume of distribution increased in correlation with age-related growth in body weight. T1/2 ranged from 21–37 hours across groups, slightly shorter than adult T1/2 of 40 hours. Complete Response (no emesis no rescue, 0–24 hours) rates showed overlapping Confidence Intervals in the two dose groups (37.1% [22.0%-55.1%] at 3 mcg/kg, n=35; and 54.1% [37.1%-70.2%] at 10 mcg/kg, n=37). Conclusions: PALO, dosed according to patient's weight at 3 and 10 mcg/kg, was effective and well tolerated in the pediatric population. No significant financial relationships to disclose.

Ex Vivo Inhibition of Platelet Aggregation in Patients with Severe Limb Arteriopathy Treated with BAY U3405, a Specific IX A2 Receptor Antagonist

1994 ◽  
Vol 72 (05) ◽  
pp. 659-662 ◽  
Author(s):  
S Bellucci ◽  
W Kedra ◽  
H Groussin ◽  
N Jaillet ◽  
P Molho-Sabatier ◽  
...  
Keyword(s):  
Platelet Aggregation ◽  
Ex Vivo ◽  
Randomized Study ◽  
In Vivo Studies ◽  
Walking Distance ◽  
Peripheral Blood Flow ◽  
Walking Ability ◽  
Double Blind ◽  
Platelet Factor

SummaryA double-blind, placebo-controlled randomized study with BAY U3405, a specific thromboxane A2 (TX A2) receptor blocker, was performed in patients suffering from severe stade II limb arteriopathy. BAY U3405 or placebo was administered in 16 patients at 20 mg four times a day (from day 1 to day 3). Hemostatic studies were done before therapy, and on day 2 and day 3 under therapy. On day 3, BAY U3405 was shown to induce a highly statistically significant decrease of the velocity and the intensity of the aggregations mediated by arachidonic acid (56 ± 37% for the velocity, 58 ± 26% for the intensity) or by U46619 endoperoxide analogue (36 ± 35% for the velocity, 37 ± 27% for the intensity). Similar results were already observed on day 2. By contrast, such a decrease was not noticed with ADP mediated platelet aggregation. Furthermore, plasma levels of betathrombo-globulin and platelet factor 4 remained unchanged. Peripheral hemodynamic parameters were also studied. The peripheral blood flow was measured using a Doppler ultrasound; the pain free walking distance and the total walking ability distance were determined under standardized conditions on a treadmill. These last two parameters show a trend to improvement which nevertheless was not statistically significant. All together these results encourage further in vivo studies using BAY U3405 or related compounds on a long-term administration.

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