Cefazolin plus Ceftazidime versus Imipenem / Cilastatin Monotherapy for Treatment of Capd Peritonitis — a Randomized Controlled Trial

2004 ◽  
Vol 24 (5) ◽  
pp. 440-446 ◽  
Author(s):  
Chi-Bon Leung ◽  
Cheuk-Chun Szeto ◽  
Kai-Ming Chow ◽  
Bonnie Ching-Ha Kwan ◽  
Angela Yee-Moon Wang ◽  
...  
Keyword(s):  
Treatment Group ◽  
Response Rate ◽  
Controlled Trial ◽  
Group Versus ◽  
Similar Efficacy ◽  
Primary Response ◽  
Control Group ◽  
Cure Rate ◽  
Open Label ◽  
Complete Cure

Background Peritonitis is a serious complication of peritoneal dialysis (PD). We studied the efficacy of imipenem / cilastatin monotherapy in the treatment of PD-related peritonitis. Methods We performed an open-label, randomized control study comparing imipenem / cilastatin monotherapy (treatment group) versus cefazolin plus ceftazidime (control group) in the treatment of PD peritonitis. The result was further compared to a historic group treated with cefazolin plus netilmycin. Outcome measures were primary response rate at day 10 and complete cure rate. Results We enrolled 51 patients in the treatment group, 51 in the control group, and identified 96 in the historic group. The primary response rate to the assigned antibiotics was 49.0%, 51.0%, and 49.0% for the treatment, control, and historic groups, respectively ( p = 0.97). The primary response rate allowing for change in antibiotic was 82.4%, 90.2%, and 82.3%, respectively, for the three groups ( p = 0.41). The complete cure rate was 72.5%, 80.4%, and 82.3%, respectively ( p = 0.60). Tenckhoff catheter removal was needed in 6 cases in the treatment group, 6 cases in the control group, and 13 cases in the historic group ( p = 0.90). Conclusions We concluded that monotherapy of imipenem / cilastatin has similar efficacy compared to the two standard regimens of cefazolin plus ceftazidime or netilmycin in the treatment of PD peritonitis.

scholarly journals Excellent Early Outcomes of Combined Chemotherapy with Arsenic Trioxide for Stage 4/M Neuroblastoma in Children A Multi center Nonrandomize d Controlled Trial

2021 ◽  
Author(s):  
Chunmou Li ◽  
Xiaomin Peng ◽  
Chuchu Feng ◽  
Xilin Xiong ◽  
Jianxin Li ◽  
...  
Keyword(s):  
Arsenic Trioxide ◽  
Pediatric Patients ◽  
Response Rate ◽  
Controlled Trial ◽  
Objective Response ◽  
Treatment Protocol ◽  
Control Group ◽  
Combined Chemotherapy ◽  
Open Label ◽  
Stage 4

This nonrandomized, multi center cohort, open label clinical trial evaluated theefficacy and safety of combined chemotherapy with arsenic trioxide (ATO) in childrenwith stage 4/M neuroblastoma (NB). We enrolled patients who were newly diagnosedwith NB and assessed as stage 4/M and received either traditional chemotherapy or ATOcombined with chemotherapy according to their own wishes. Twenty two patients wereenrolled i n the trial group (ATO combined with chemotherapy) and thirteen patientswere enrolled in the control group (traditional chemotherapy). Objective response rate(ORR) at 4 weeks after completing induction chemotherapy was defined as the mainoutcome and adv erse events were monitored and graded in the meantime. Data cutoffdate was Dec. 31, 2019. Finally, we found that p patients who received ATO combined with chemotherapy had a significantly higher response rate than those who treated with traditional chemotherapy (ORR: 86.36% vs 46.16%, P=0.020). Reversible cardiotoxicity was just observed in 3 patients who treated with ATO and no other differential adverse events were observed between two groups. ATO combined with chemotherapy can significantly improve end-induction response in high-risk neuroblastoma and our novel regimen is well tolerated in pediatric patients. These results highlight the superiority of chemotherapy with arsenic trioxide, which creates new opportunity for prolonging survival. Besides, this treatment protocol furthest minimizes therapeutic costs compared with anti-GD2 therapy, MIBG and proton therapy, and can decrease the burden to families and society. However, we also need to bring into more cases to consolidate our conclusion.

scholarly journals Efficacy and Safety of Lianhuaqingwen Capsules for the Prevention of Coronavirus Disease 2019: A Prospective Open-Label Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiaowei Gong ◽  
Boyun Yuan ◽  
Yadong Yuan ◽  
Fengju Li
Keyword(s):  
Nucleic Acid ◽  
Treatment Group ◽  
Close Contact ◽  
Controlled Trial ◽  
Control Group ◽  
Open Label ◽  
Medical Observation ◽  
Observation Period ◽  
Close Contacts ◽  
Nucleic Acid Tests

Coronavirus disease 2019 (COVID-19) has become a global pandemic. Community and close contact exposures continue to drive the COVID-19 pandemic. There is no confirmed effective treatment for suspected cases and close contacts. Lianhuaqingwen (LH) capsules, a repurposed Chinese herbal product that is currently on the market, have proven effective for influenza and COVID-19. To determine the safety and efficacy of LH capsules for the prevention of COVID-19, we conducted a prospective open-label controlled trial of LH capsules on subjects who had close contact with people infected with COVID-19. Subjects received LH capsules (4 capsules, three times daily) or the usual medical observation for 14 days. The primary endpoint was the rate of positive nucleic acid tests of nasal and pharyngeal swabs during the quarantine medical observation period. We included 1976 patients, including 1101 in the treatment group and 875 in the control group. The rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.27% vs. 1.14%, respectively; mean difference: −0.87%; 95% CI: −1.83 to −0.13; p = 0.0174 ) during the quarantine medical observation period (14 days). Among subjects with different close contact states, there was no significant difference in the rate of positive nucleic acid test results among close contacts in the treatment group and the control group (6.45% vs. 11.43%, respectively; p = 0.6762 ). Among secondary close contacts, the rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.09% vs. 0.71%, respectively; p = 0.0485 ). No serious adverse events were reported. Taken together, and in light of the safety and effectiveness profiles, these results show that LH capsules can be considered to prevent the progression of COVID-19 after close contact with an infected person. This trial is registered with ChiCTR2100043012.

Effectiveness and Safety of an Inactivated Enterovirus 71 Vaccine in Children Aged 6–71 Months in a Phase IV Study

2019 ◽  
Vol 71 (9) ◽  
pp. 2421-2427 ◽  
Author(s):  
Xuhua Guan ◽  
Yanchun Che ◽  
Sheng Wei ◽  
Shaoping Li ◽  
Zhimei Zhao ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Large Population ◽  
Enterovirus 71 ◽  
Group Versus ◽  
Vaccine Group ◽  
Incidence Density ◽  
Control Group ◽  
Passive Surveillance ◽  
Open Label ◽  
Phase Iv

Abstract Background Evaluation of a licensed inactivated enterovirus type 71 (EV71) vaccine is needed in a phase IV study with a large population to identify its effectiveness and safety for further application. Methods An open-label, controlled trial involving a large population of 155 995 children aged 6–71 months was performed; 40 724 were enrolled in the vaccine group and received 2 doses of inactivated EV71 vaccine at an interval of 1 month, and the remaining children were used as the control group. The EV71-infected cases with hand, foot, and mouth disease were monitored in the vaccine and control groups during a follow-up period of 14 months since the 28th day postinoculation through the local database of the Notifiable Infectious Diseases Network. The effectiveness of the vaccine was estimated by comparing the incidence density in the vaccine group versus that in the control group based upon EV71-infected patients identified via laboratory testing. In parallel, the active and passive surveillance for safety of the vaccine was conducted by home or telephone visits and by using the Adverse Event Following Immunization (AEFI) system, respectively. Results An overall level of 89.7% (95% confidence interval, 24.0–98.6%) vaccine effectiveness against EV71 infection and a 4.58% rate of reported adverse events were observed. Passive surveillance demonstrated a 0.31% rate of reported common minor reactions. Conclusions The clinical protection and safety of the EV71 vaccine were demonstrated in the immunization of a large population. Clinical Trials Registration NCT03001986.

scholarly journals Campylobacter Peritonitis Complicating Peritoneal Dialysis: A Review of 12 Consecutive Cases

2013 ◽  
Vol 33 (2) ◽  
pp. 189-194
Author(s):  
Terry King-wing Ma ◽  
Kin Ping Lee ◽  
Kai Ming Chow ◽  
Wing Fai Pang ◽  
Bonnie Ching Ha Kwan ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Response Rate ◽  
Primary Response ◽  
Resistance Rate ◽  
Cure Rate ◽  
First Line ◽  
Dialysis Unit ◽  
Complete Cure ◽  
Conventional Antibiotics ◽  
Culture Negative

BackgroundPeritoneal dialysis–associated peritonitis secondary to Campylobacter organisms is uncommon. Few studies have assessed either treatment or clinical outcomes.MethodsWe reviewed all Campylobacter peritonitis episodes occurring in a single dialysis unit from 1994 to 2011.ResultsDuring the study period, 12 episodes of Campylobacter peritonitis (0.45% of all peritonitis episodes) were recorded. Diarrhea was uncommon (8.3%). The overall primary response rate was 91.7%; the complete cure rate was 75.0%. Among 6 patients who failed to respond to standard antibiotics by day 5, all improved after administration of an oral macrolide (erythromycin or clarithromycin). Of those 6 patients, 5 experienced a complete cure, and 1 patient experienced relapse of culture-negative peritonitis. No patient required Tenckhoff catheter removal or temporary hemodialysis support. The 30-day mortality was 0%.ConclusionsCampylobacter peritonitis might not respond to first-line conventional antibiotics, and an oral macrolide is recommended if Campylobacter is confirmed. The findings from our analysis do not support the use of fluoroquinolone, which is associated with a high resistance rate.

scholarly journals Safety and Efficacy of Repurposed Siddha Medicines in Mild, Moderate, and Severe COVID-19 Patients Admitted To a Government Tertiary Hospital Near Chennai, Tamil Nadu– An Open-Labeled, Randomized, Controlled Trial.

2021 ◽  
Author(s):  
Christian G J ◽  
Meenakumari Ramasamy ◽  
Shanthimalar Ramalingam ◽  
Sankar Ganesan ◽  
Ravichandran Vadugam Muthusamy ◽  
...  
Keyword(s):  
Treatment Group ◽  
Standard Care ◽  
Tamil Nadu ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Tertiary Hospital ◽  
Control Group ◽  
Open Label ◽  
Randomized Controlled ◽  
Oxygenation Status

Abstract BackgroundCOVID-19 resulted in loss of human lives owing to respiratory failure caused by dysregulated immune system. Though many treatments are evaluated, the most appropriate is yet to be established. We hypothesized accelerated recovery and reduced mortality in mild, moderate and severe COVID-19 with Siddha regimen consisting of natural products.MethodsIn a randomized, controlled open-label trial conducted on 200 hospitalized COVID-19 patients, they were allocated equally to be treated with add-on Siddha regimen with Standard care or only standard care. The primary and secondary end points were accelerated recovery (≤ 7 days) and mortality comparison between the groups respectively. Patients were followed through 90 days.ResultsIn this study the accelerated recovery was 59.0% and 27.0% in treatment and control group (ITT analyses) (p < 0.001) respectively and Odds for it were four times higher in the treatment group (OR: 3.9; 95% CI: 1.9, 8.0). The estimated median time for recovery in the treatment group was 7 days (95% CI: 6.0, 8.0; p=0.003) and 10 days (95% CI: 8.7, 11.3) in control. Hazard ratio for death in control was 2.3 times that of treatment group. No adverse reactions or alarming laboratory values were observed in response to intervention. In severe treatment group (n=80), mortality was 15.0% and 39.5% in control (n=81). The COVID stage progression was 65% less in treatment group.ConclusionSiddha regimen demonstrated that they can synergistically improve oxygenation status, enhance the recovery rate and reduce the mortality better as compared to only Standard of Care.

scholarly journals A Four Month Randomized Controlled Trial on the Efficacy of Once-daily Fenofibrate Monotherapy in Persons with Spinal Cord Injury

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Michael F. La Fountaine ◽  
Christopher M. Cirnigliaro ◽  
Joshua C. Hobson ◽  
Alexander T. Lombard ◽  
Adam F. Specht ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Treatment Group ◽  
Controlled Trial ◽  
Serum Lipoprotein ◽  
Control Group ◽  
Lipoprotein Profile ◽  
Open Label ◽  
Once Daily ◽  
Cord Injury

AbstractAn open-label, randomized clinical trial of once-daily fenofibrate monotherapy administered for 2- (Mo2) and 4- (Mo4) months using modified intervention thresholds for triglyceride (TG) was performed in persons with chronic spinal cord injury (SCI). Fenofibrate (145 mg tablet) was self-administered daily in 10 persons with SCI for 4 months with monthly blood testing to quantify the lipoprotein profile (e.g., serum TG, LDL-C, and HDL-C concentrations). Eight SCI participants were control subjects. In comparison to the control group, the treatment group at Mo2 had a 40% (±12%; p < 0.05) reduction in serum TG concentration, a 28% (±21%; p < 0.05) increase in HDL-C and 14% (±20%; p < 0.05) decline in LDL-C. In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.

scholarly journals Chinese medicine (Q-14) in the Treatment of Patients with Coronavirus Disease 2019 (COVID-19): A Single-center, Open label, Randomised Controlled Trial

2021 ◽  
Author(s):  
Jia Liu ◽  
Wei Yang ◽  
Yue Liu ◽  
Cheng Lv ◽  
Lianguo Ruan ◽  
...  
Keyword(s):  
Treatment Group ◽  
Standard Care ◽  
Controlled Trial ◽  
Control Group ◽  
Chest Discomfort ◽  
Open Label ◽  
Conversion Time ◽  
Q 14 ◽  
Randomised Controlled ◽  
And Control

ABSTRACTOBJECTIVETo evaluate the efficacy and safety of Chinese medicine (Q-14) plus standard care compared with standard care alone in adult with coronavirus disease 2019 (COVID-19).Study DESIGNSingle-center, open label, randomised controlled trial.SETTINGWuhan Jinyintan Hospital, Wuhan, China, February 27 to March 27, 2020.PARTICIPANTS204 patients with laboratory confirmed COVID-19 were randomised in to treatment group and control group, which was 102 patients each group.INTERVENTIONSIn treatment group, Q-14 was administrated at 10g (granules), twice daily for 14 days and plus standard care. In control group, patients were given standard care alone for 14 days.MAIN OUTCOME MEASUREThe primary outcome was conversion time of SARS-CoV-2 viral assay. Adverse events were analyzed in the safety population.RESULTSAmong 204 patients, 195 were analyzed according to the intention to treat principle. There were 149 patients (71 vs. 78 in treatment group and control group respectively) turning to negative via SARS-CoV-2 viral assay. No statistically significance showed in conversion time between treatment group and control group (FAS: Median (IQR): 10.00 (9.00-11.00) vs. 10.00 (9.00-11.00); Mean rank: 67.92 vs. 81.44; P=0.051.). Time to recovery of fever was shorter in treatment group as compared in control group. The disappearance rate of symptom in cough, fatigue, chest discomfort was significantly higher in treatment group. In chest computed tomography (Chest CT) examinations, overall evaluation of chest CT examination after treatment compared with baseline showed more patients improved in treatment group .There were no significant differences in the other outcomes.CONCLUSIONAdministration of Q-14 on standard care for COVID-19 was useful for improvement of symptoms (such as fever, cough, fatigue and chest discomfort), while did not result in a significantly higher probability of negative conversion of SARS-CoV-2 viral assay. No serious adverse events were reported.TRIAL REGISTRATIONChiCTR2000030288

Efficacy of Nimodipine Plus Yufeng Ningxin Tablets for Patients with Frequent Migraine

Pharmacology ◽  
2018 ◽  
Vol 102 (1-2) ◽  
pp. 53-57
Author(s):  
Hongmei Mu ◽  
Liyong Wang
Keyword(s):  
Treatment Group ◽  
Visual Analogue Scale ◽  
Analogue Scale ◽  
Response Rate ◽  
Control Group ◽  
Migraine Treatment ◽  
Cure Rate ◽  
High Cure Rate ◽  
Vas Score ◽  
Significant Difference

Background/Aims: To test the effects of Nimodipine plus Yufeng Ningxin tablets on frequent migraine. Methods: Two hundred forty-two patients with frequent migraine were divided into the control group with those consuming Flunarizine (120 cases) and the treatment group with those consuming Nimodipine plus Yufeng Ningxin tablets (122 cases). The course of frequent migraine treatment lasted 7 weeks. The number of migraine days, visual analogue scale (VAS) score, and response rate were measured. Results: There was significant difference in the cure rate as the Nimodipine plus Yufeng Ningxin tablets group compared with the Flunarizine group (78.7 vs. 21.7%; p < 0.001). Fewer migraine days and VAS score were observed in the treatment group when compared with the control group (p < 0.05). Nimodipine plus Yufeng Ningxin tablets were superior to Flunarizine in terms of the response rate at week 7 (p < 0.05). Conclusion: Due to its high cure rate, treatment with Nimodipine plus Yufeng Ningxin tablets is recommended to control frequent migraine, and this hypothesis needs to be confirmed through further studies conducted on a more extensive population.

Regression of cardiac amyloid deposits with novel therapeutics: reaching new frontiers in cardiac ATTR amyloidosis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Chacko ◽  
A Martinez-Naharro ◽  
T Kotecha ◽  
R Martone ◽  
D Hutt ◽  
...  
Keyword(s):  
Treatment Group ◽  
Cardiac Amyloidosis ◽  
T1 Mapping ◽  
Group Versus ◽  
Control Group ◽  
Cardiac Amyloid ◽  
Attr Amyloidosis ◽  
Amyloid Load ◽  
The Impact

Abstract Background Cardiac involvement is the main driver of outcome in ATTR amyloidosis. Advances in therapeutics hold potential in transforming the course of the disease but the impact on cardiac amyloid load is unknown. The aim of this study was to evaluate the impact of patisiran, a new double stranded RNA based gene silencing therapy and a stabilizer, diflunisal, on cardiac amyloid load as measured by CMR and T1 mapping, in patients with ATTR amyloidosis. Methods and results Thirty-two patients with hereditary cardiac amyloidosis were studied. Sixteen patients received treatment with patisiran, and sixteen control subjects did not receive any disease modifying treatment. Patients were assessed with echocardiogram, CMR, NT-proBNP and six-minute walk time measurements at baseline and at 1 year (Mean interval 11.45±3.08 months in treatment group, mean interval 12.82±5.06 months in the control group). CMR analysis comprised LV volumes, T1 mapping to measure the extracellular volume (ECV) occupied by amyloid, T2 mapping and late gadolinium enhancement imaging. At 1-year follow-up, there was a substantial reduction in cardiac amyloid burden, in keeping with cardiac amyloid regression in 45% of patients on treatment. Overall the treatment group showed a reduction in ECV at 1 year follow up compared to an increase in ECV at 1 year in the control group (−1.37%, 95% CI: −3.43 to 0.68% versus 5.02%, 95% CI: 2.86% to 7.18% respectively, p&lt;0.001). The treatment group also showed an improvement in change in 6MWT at 1 year follow up compared to 6MWT at 1 year in the control group (−8.12 meters, 95% CI: −50.8 to 34.6 meters in the treatment group versus −132.27 meters, 95% CI: −216 to −48.6 meters in the control group, p=0.002). The treatment group showed a reduction in BNP at 1 year follow up compared to an increase in the control group (−567.87, 95% CI: −1288.90 to 153.15 in the treatment group versus 2004, 95% CI: 12.82 to 3995.45 in the control group, p&lt;0.001). There was no significant difference from baseline and 1-year data between the control and treatment groups for the difference in echocardiographic parameters, native T1, T2. There was a significant reduction in the percentage of injected dose by 99Tc-DPD scintigraphy in treated patients at 1 year compared to baseline. Conclusions These findings provide the first compelling evidence of substantial cardiac amyloid regression in ATTR amyloidosis, as well as the potential for CMR to be used to track response in treated patients with ATTR cardiac amyloidosis. Combination therapy with transthyretin knock down and stabilizing agents may well be synergistic given enhanced stoichiometry of stabilizers in the face of much reduced plasma transthyretin concentration. Funding Acknowledgement Type of funding source: None

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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