Comparative Effectiveness of Amoxicillin and Amoxicillin-Clavulanate Potassium in Acute Paranasal Sinus Infections in Children: A Double-Blind, Placebo-Controlled Trial

PEDIATRICS ◽  
1986 ◽  
Vol 77 (6) ◽  
pp. 795-800 ◽  
Author(s):  
Ellen R. Wald ◽  
Darleen Chiponis ◽  
Jocyline Ledesma-Medina
Keyword(s):  
Group A Streptococcus ◽  
Maxillary Sinusitis ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Nasal Discharge ◽  
Cure Rate ◽  
Double Blind ◽  
Amoxicillin Clavulanate ◽  
Group A ◽  
To Receive

This study compared the relative effectiveness of two antimicrobial preparations, amoxicillin and amoxicillin-clavulanate potassium (Augmentin), in the treatment of acute maxillary sinusitis in children 2 to 16 years of age. Of 171 children with persistent (ten to 30 days' duration) nasal discharge or daytime cough or both, 136 (80%) had abnormal maxillary sinus radiographs. These children were stratified by age and severity of symptoms and randomly assigned to receive either amoxicillin, amoxicillin-clavulanate potassium, or placebo. After the exclusion of 28 children with throat cultures positive for group A Streptococcus and 15 who did not complete their medication, the remaining 93 children were evaluated: 30 received amoxicillin, 28 received amoxicillin-clavulanate potassium, and 35 received placebo. Clinical assessment was performed at three and ten days. On each occasion, children treated with an antibiotic were more likely to be cured than children receiving placebo (P < .01 at three days, P < .05 at ten days). The overall cure rate was 67% for amoxicillin, 64% for amoxicillin-clavulanate potassium, and 43% for placebo.

Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

2020 ◽  
pp. 1-3
Author(s):  
Maximilian Jorczyk
Keyword(s):  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Double Blind ◽  
Mechanically Ventilated ◽  
Before And After ◽  
Anti Inflammatory ◽  
To Receive ◽  
Therapeutic Possibilities ◽  
Inflammatory Effect

<b>Introduction:</b> Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. <b>Objective:</b> The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. <b>Methods:</b> This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for <i>Ureaplasma</i>. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). <b>Results:</b> Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O<sub>2</sub> dependency at 28 days/death in azithromycin-treated patients regardless of the detection of <i>Ureaplasma</i> in blood. <b>Conclusions:</b> Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O<sub>2</sub> dependency at 28 days/death in mechanically ventilated preterm neonates.

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Randomized Controlled ◽  
Venous Ulcers ◽  
Group A ◽  
Group B ◽  
To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

The effect of external ventricular drain tunneling length on CSF infection rate in pediatric patients: a randomized, double-blind, 3-arm controlled trial

2021 ◽  
pp. 1-8
Author(s):  
Esmaeil Mohammadi ◽  
Sara Hanaei ◽  
Sina Azadnajafabad ◽  
Keyvan Tayebi Meybodi ◽  
Zohreh Habibi ◽  
...  
Keyword(s):  
Infection Rate ◽  
Pediatric Patients ◽  
Controlled Trial ◽  
External Ventricular Drain ◽  
Hazard Ratio ◽  
Spontaneous Discharge ◽  
Standard Group ◽  
Double Blind ◽  
Group A ◽  
Group B

OBJECTIVE The role of tunneling an external ventricular drain (EVD) more than the standard 5 cm for controlling device-related infections remains controversial. METHODS This is a randomized, double-blind, 3-arm controlled trial done in the Children’s Medical Center in Tehran, Iran. Pediatric patients (< 18 years old) with temporary hydrocephalus requiring an EVD and no evidence of CSF infection or prior EVD insertion were enrolled. Patients were randomly assigned (1:1:1) into the following arms: 5-cm (standard; group A); 10-cm (group B); or 15-cm (group C) EVD tunnel lengths. The investigators, parents, and person performing the analysis were masked. The surgeon was informed of the length of the EVD by the monitoring board just before operation. Patients were followed until the EVD’s fate was established. Infection rate and other complications related to EVDs were assessed. RESULTS A total of 105 patients were enrolled in three random groups (group A = 36, group B = 35, and group C = 34). The EVD was removed because there was no further need in most cases (67.6%), followed by conversion to a new EVD or ventriculoperitoneal shunt (15.2%), infection (11.4%), and spontaneous discharge without further CSF diversion requirement (5.7%). No statistical difference was found in infection rate (p = 0.47) or EVD duration (p = 0.81) between the three groups. No group reached the efficacy point sooner than the standard group (group B: hazard ratio 1.21, 95% CI 0.75–1.94, p = 0.429; group C: hazard ratio 1.03, 95% CI 0.64–1.65, p = 0.91). CONCLUSIONS EVD tunnel lengths of 5 cm and longer did not show a difference in the infection rate in pediatric patients. Indeed, tunneling lengths of 5 cm and greater seem to be equally effective in preventing EVD infection. Clinical trial registration no.: IRCT20160430027680N2 (IRCT.ir)

scholarly journals Efficacy of Oral Acetaminophen and Intravenous Chlorpheniramine Maleate versus Placebo to Prevent Red Cell Transfusion Reactions in Children and Adolescent with Thalassemia: A Prospective, Randomized, Double-Blind Controlled Trial

Anemia ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Piya Rujkijyanont ◽  
Chalinee Monsereenusorn ◽  
Pimpat Manoonphol ◽  
Chanchai Traivaree
Keyword(s):  
Blood Transfusion ◽  
Controlled Trial ◽  
Febrile Reaction ◽  
Chlorpheniramine Maleate ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Urticarial Rash ◽  
To Receive ◽  
Transfusion Reactions ◽  
Rbc Transfusion

Background. Thalassemia is a common congenital hemolytic disorder. In severe cases, regular blood transfusion is essentially required. The role of premedications to prevent transfusion reactions is varied among institutions with no standard guideline. Objective. To prospectively compare the risk of transfusion reactions in thalassemia patients premedicated with acetaminophen and chlorpheniramine maleate (CPM) versus placebo prior to blood transfusion. Material and Method. A randomized, double-blinded, placebo-controlled transfusion reaction study of 147 eligible patients was analyzed. All administered red blood cell (RBC) products were leukoreduced blood products. Patients were monitored and followed for the development of transfusion reactions for 24 hours after RBC transfusion. Results. A total of 73 patients randomized to receive active drugs consisting of acetaminophen and CPM were compared to 74 patients receiving placebo. The overall incidences of febrile reaction and urticarial rash were 6.9% and 22% in the patients randomized to receive active drugs comparing with 9.5% and 35.2% in the patients receiving placebo with no significant differences between two groups. However, delayed development of urticarial rash at 4-24 hours after RBC transfusion was significantly higher in female and patients receiving placebo. Conclusion. Administration of premedications in thalassemia patients receiving RBC transfusion without a history of transfusion reactions does not decrease the overall risk of transfusion reactions. However, the use of CPM might be beneficial to prevent delayed urticarial rash in those patients especially in females (Thai Clinical Trial Registry (TCTR) study ID: 20140526001).

scholarly journals Effect of oral sugar solution for reducing pain in infants underwent diphtheria, pertussis, tetanus (DPT) im- munization: a randomized, double-blind controlled trial

2008 ◽  
Vol 48 (1) ◽  
pp. 23 ◽  
Author(s):  
Arief Priambodo ◽  
Madarina Julia ◽  
Djauhar Ismail
Keyword(s):  
Median Duration ◽  
Controlled Trial ◽  
Intervention Group ◽  
Oral Solution ◽  
Health Centers ◽  
Sugar Solution ◽  
Negative Effects ◽  
Double Blind ◽  
Primary Health ◽  
To Receive

Background Infants are often subjected to painful procedures suchas diphtheria, pertussis, tetanus (DTP) immunization. Despiteits negative effects, pain in infants has not got enough attention.Sweet oral solution has analgesic effect.Objective To determine whether oral sugar solution can reducethe duration of crying in infants who got DTP immunization.Methods This was a randomized, double-blind controlled trialperformed at Growth and Development Clinic of Dr. SardjitoGeneral Hospital and two Primary Health Centers in Yogyakarta.Study subjects were 4-6 month-old infants who got the 3 rd DTPimmunization. Subjects were randomly allocated to receive 2 ml75% oral sugar solution (intervention group) or 2 ml drinkingwater (placebo) just before the immunization. Crying was recordedfrom just before the injection until 3 minutes after.Results Eighty-six subjects were enrolled; 42 subjects receivedsugar solution and 44 subjects received placebo. Sugar solutionreduced the median duration of first cry about 38 seconds or 32%(P=0.03) and reduced the median duration of total crying about35 seconds or 24% (P=0.02).Conclusion Administration of 2 ml 75% oral sugar solution canalleviate pain associated with DTP immunization as shown byreduced duration of crying.

A double-blind placebo-controlled trial of perioperative prophylactic antibiotics for elective neurosurgery

1988 ◽  
Vol 69 (5) ◽  
pp. 687-691 ◽  
Author(s):  
Ross Bullock ◽  
James R. van Dellen ◽  
William Ketelbey ◽  
S. Gustav Reinach
Keyword(s):  
Controlled Trial ◽  
Prophylactic Antibiotics ◽  
Risk Of Infection ◽  
Broad Spectrum Antibiotic ◽  
Wound Sepsis ◽  
Double Blind ◽  
Content Type ◽  
Exact Test ◽  
Significant Difference ◽  
To Receive

✓ In this study, 417 patients undergoing “clean” elective neurosurgical operative procedures were randomized to receive a broad-spectrum antibiotic (piperacillin) or placebo given as three perioperative doses, each 6 hours apart. Randomization was carried out by hospital pharmacists, and the investigators remained blinded until the end of the study. Twenty cases were excluded from analysis because either an unforeseen second operation was performed or antibiotic therapy was initiated within 30 days after surgery to treat infection or the risk of infection. Twelve of the 205 patients treated with placebo developed postoperative wound sepsis, and four of the 192 piperacillin-treated patients developed wound sepsis — a statistically significant difference (p < 0.05, Fisher's exact test). Piperacillin thus appeared to reduce the incidence of neurosurgical wound infection in this study.

scholarly journals Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

2021 ◽  
Author(s):  
Juan Manuel Figueroa ◽  
Monica Lombardo ◽  
Ariel Dogliotti ◽  
Luis Flynn ◽  
Robert P. Giugliano ◽  
...  
Keyword(s):  
Placebo Group ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Hospital Personnel ◽  
Culture Methods ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Efficacy ◽  
To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

ERYTHROMYCIN PROPIONATE AND POTASSIUM PENICILLIN V IN THE TREATMENT OF GROUP A STREPTOCOCCAL PHARYNGITIS

PEDIATRICS ◽  
1963 ◽  
Vol 31 (1) ◽  
pp. 22-28
Author(s):  
Maxwell Stillerman ◽  
Stanley H. Bernstein ◽  
Martha Smith ◽  
Jack D. Gorvoy
Keyword(s):  
Relative Effectiveness ◽  
Streptococcal Pharyngitis ◽  
Group A Streptococci ◽  
Cure Rate ◽  
Acute Pharyngitis ◽  
Penicillin V ◽  
Daily Dose ◽  
Group A ◽  
Potassium Penicillin

The relative effectiveness of erythromycin propionate and K penicillin V in two dosage schedules was evaluated in the treatment of 261 cases of acute pharyngitis from which Group A hemolytic streptococci were recovered from December, 1958, to June, 1959. Erythromycin propionate, in a daily dose of 30 mg/kg up to 1.0 gm, and K penicillin V, in daily doses of 375 mg and 750 mg, were administered orally for 10 days. The adjusted bacterial cure rate was 78% among 86 patients treated with erythromycin, 72% among 102 patients treated with K penicillin V, 375 mg, and 88% among 73 patients treated with K penicillin V, 750 mg. The data indicate that K penicillin V was more effective in eradicating Group A streptococci from the pharynx in a daily dose of 750 mg than 375 mg, and suggest that erythromycin propionate in the dosage used, was less effective than K penicillin V, 750 mg, but equally as effective as K penicillin V, 375 mg daily. The incidence, time of occurrence, and results of retreatments of bacterial relapses are presented, and two possible causes of relapses are considered.

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